The Vineti/EVERSANA partnership looks at the cell and gene therapy lifecycle holistically and tracks both the product and patient journeys concurrently. EVERSANA's pre- and post-commercial launch services effectively plan market access, clinical trial recruitment, global pricing, patient and HCP engagement, patient and market access and adherence support, therapy storage and distribution needs, and outcomes measurement, with each step measured and optimized by a fully integrated data and analytics platform.

Vineti's Personalized Therapy Management platform automates the Chain of Identity, Chain of Custody and Chain of Condition while enabling the sophisticated scheduling of manufacturing and shipping to hospitals and labs worldwide with industry-leading user experience.

Under the alliance, clients will be able to view patient orders that originated from Vineti and are supported by EVERSANA's integrated commercial services, giving a full view of the patient and product journeys and saving time going back and forth between systems and multiple vendors.

"We're very excited to partner with EVERSANA to help overcome the inherent complexity of cell and gene therapies and provide efficient, integrated solutions for manufacturers and patients," said Vineti CEO and Co-founder Amy DuRoss. "Vineti is focused on industrializing advanced therapies so that all patients in need can benefit. This type of integrated solution with EVERSANA is essential to that goal."

"We're amazed when we look at the pipeline for cell and gene therapies and the hope that's been created for millions of patients worldwide. But as an industry, we have to make that hope a reality by tackling the access, affordability and logistics challenges in this sector," said Jim Lang, CEO, EVERSANA. "That's why we are partnering with best-in-class technology providers like Vineti who share our vision for an accelerated regenerative medicine pipeline that gets products to patients safely, effectively and in a value- and data-driven model. Innovators carry less risk and more financial predictability, while their patients have the promise of healthier lives."

The alliance ensures that EVERSANA clients will be able to view patient orders that originated from Vineti, giving them a full view of the patient journey and saving time going back and forth between systems. Vineti clients will be able to access EVERSANA's solutions through the Vineti Alliance Network.

Media

Stacy Henry Vineti[emailprotected]

Sarah Zwicky EVERSANA[emailprotected]

About Vineti

Vineti is the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, manufacturing and clinical data for personalized therapies. The Vineti platform supports the full continuum of patient-specific therapies, including cancer vaccines and autologous and allogeneic therapies. The company is expanding rapidly, and Vineti's Personalized Therapy Management (PTM) platform was in use in hundreds of leading medical centers worldwide in 2019, on behalf of multiple biopharmaceutical partners. In 2019, the World Economic Forum selected Vineti as a global Technology Pioneer.

About EVERSANA

EVERSANA is the leading provider of global services to the life science industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

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Vineti and EVERSANA form strategic alliance to advance patient-centered services and supply chain automation for regenerative medicine - PRNewswire

ROCKVILLE, Md., July 30, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAVTechnology Platform, today announced that it will host a conference call on Thursday, August 6, 2020, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2020, and recent operational highlights.

To access the live call by phone, dial (800) 708-4539 (domestic) or (800) 619-6396 (international) and enter the passcode 49857700. To access a live or recorded webcast of the call, please visit the Investors section of the REGENXBIO website at http://www.regenxbio.com. The recorded webcast will be available for approximately 30 days following the call.

AboutREGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Contacts:

Tricia TruehartInvestor Relations and Corporate Communications347-926-7709[emailprotected]

Investors:Eleanor Barisser, 212-600-1902[emailprotected]

Media:David Rosen, 212-600-1902[emailprotected]

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REGENXBIO To Host Conference Call on August 6 to Discuss Second Quarter 2020 Financial Results and Recent Operational Highlights - PRNewswire

The Gene Therapy Market market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

It incorporates Gene Therapy Market market evolution study, involving the current scenario, growth rate (CAGR), and SWOT analysis. Important the study on Gene Therapy Market market takes a closer look at the top market performers and monitors the strategies that have enabled them to occupy a strong foothold in the market. Apart from this, the research brings to light real-time data about opportunities that will completely transform the trajectory of the business environment in the coming years to 2025. Some of the key players in the global Gene Therapy Market market is Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical, Advantagene.

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Gene Therapy Market Market: Competitive Landscape:

The competitive landscape further includes details about different players and their position on a global and a local level is also explained in detail in this compiled study. These insights were prepared through mapping business strategies and products that offer high revenue generation capacities. An overview of the Gene Therapy Market market Comprehensive analysis of the market Analyses of recent developments in the market Events in the market scenario of the past few years Emerging market segments and regional Gene Therapy Market markets Segmentations up to the second and/or third level Historical, current, and estimated market size in terms of value and volume Competitive analysis, with company overview, products, revenue, and strategies. An impartial assessment of the market Strategic recommendations to help companies increase their Gene Therapy Market market presence.

The Key Manufacturers covered in this Report:- Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical, Advantagene.

By Therapy Type:-SomaticGermlineBy Vector Type:-

non-viral Vectorsviral vectorsBy Application:-

Cancer DiseasesMonogenic DiseasesInfectious DiseasesCardiovascular Diseases Others

The key regions covered in the Gene Therapy Market market report are:

North America (U.S., Canada, Mexico)

South America (Cuba, Brazil, Argentina, and many others.)

Europe (Germany, U.K., France, Italy, Russia, Spain, etc.)

Asia (China, India, Russia, and many other Asian nations.)

Pacific region (Indonesia, Japan, and many other Pacific nations.)

Middle East & Africa (Saudi Arabia, South Africa, and many others.)

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Table of Contents

Report Overview: It includes major players of the global Gene Therapy Market Market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends: This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Gene Therapy Market Market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Gene Therapy Market Market are discussed.

Market Share by Manufacturers: Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type: This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application: Besides an overview of the global Gene Therapy Market Market by application, it gives a study on the consumption in the global Gene Therapy Market Market by application.

Production by Region: Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the global Gene Therapy Market Market are profiled in this section. The analysts have provided information about their recent developments in the global Gene Therapy Market Market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Gene Therapy Market Market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Gene Therapy Market Market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Gene Therapy Market Market.

Key Findings: This section gives a quick look at important findings of the research study.

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Global Gene Therapy Market Market Analysis by SWOT, Investment, Future Growth and Major Key Players 2020 to 2025 - Research Newspaper

NEW YORK, July 27, 2020 /PRNewswire/ -- Report Scope: The scope of this study encompasses an investigation of the markets cell and gene therapy tools such as GMP proteins, media, cell separation and activation reagents, viral and non-viral, cytokine release syndrome monitoring products, GMP antibodies, leukapheresis instrumentation, immunoassays (multiplex and singleplex) and bioreactors.The analyst examines each tool type, determines its current market status, examines its impact on future markets, and presents forecasts of growth over the next five years.

Read the full report: https://www.reportlinker.com/p05938974/?utm_source=PRN

Technological issues, including the latest trends, are discussed. The analyst examined the industry on a worldwide basis, from both application and demand perspectives, in the major regions of the world.

Report Includes: - 77 data tables - An overview of the global market for immunoassay-based cell and gene therapy tools, and reagents within the life sciences industry - Analyses of the global market trends, with data corresponding to market size for 2017-2019, and projections of compound annual growth rates (CAGRs) through 2024 - Information about in vitro diagnostics (IVD), its background and importance of IVD testing - Discussion on prevalence of infectious disease, metabolic disorders and chronic ailments as drivers of immunoassay testing market - Description of recent technologies such as chemiluminescent immunoassays (CLIA), fluorescent immunoassays, multiplex assays and rapid diagnostic technologies - Evaluation of market potential for immunoassay-based cell and gene therapy tools and reagents, current market size and market forecast, and market share analysis of the leading players engaged - Patent review and new developments, R&D efforts, industrial changes with emphasis on recent investments, and current state of the immunoassay technology - Company profiles of the key market participants, including Bio-Rad Laboratories, Cytiva Life Sciences, Luminex Corp., Millipore Sigma, Thermo Fisher Scientific and STEMCELL Technologies

Reasons for Doing this Study: Gene and cell therapy are emerging as important tools to treat human health.Techniques such as CAR-T therapy have emerged as key ways of treating many different types of cancers.

The promise of gene therapy using technologies such as CRISPR is starting to be realized in clinical trials, and markets are scaling up to treat other diseases as well, particularly rare gene- based diseases.As these therapies are coming to the fore, a new market for tools to develop these therapies using standard methodologies is emerging.

This report will cover what those tools are, how they impact the larger life science tools market, and how they will evolve over the next five years.

Read the full report: https://www.reportlinker.com/p05938974/?utm_source=PRN

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

Contact Clare: [emailprotected] US: (339)-368-6001 Intl: +1 339-368-6001

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Cell and Gene Therapy Tools, and Reagents: Global Markets - PRNewswire

Oxford, UK 31st July, 2020: Oxford Biomedica plc (LSE:OXB) (Oxford Biomedica or the Group), a leading gene and cell therapy group, announced today that it has signed a three year Clinical Supply Agreement (CSA) with a wholly-owned subsidiary of Axovant Gene Therapies Ltd. (Axovant) (Nasdaq: AXGT). The CSA builds on the worldwide license agreement signed between the two companies in June 2018 for the Parkinsons disease gene therapy program OXB-102, now called AXO-Lenti-PD.

Under the terms of the CSA, Oxford Biomedica will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD, a clinical-stage gene therapy product to treat moderate to severe Parkinsons Disease based on Oxford Biomedicas LentiVector platform. Axovant is currently conducting a Phase 2 SUNRISE-PD trial with AXO-Lenti-PD. Dosing of all patients in the second cohort is completed with 6-month safety and efficacy data expected in the fourth quarter of 2020. OXB expects to manufacture AXO-Lenti-PD in its commercial-scale GMP manufacturing facilities including Oxbox in the UK, and additionally in other OXB GMP facilities as required to ensure security of supply.

John Dawson, Chief Executive Officer of Oxford Biomedica, said: This new Agreement builds upon our existing worldwide licensing agreement with Axovant and highlights the strengths of Oxford Biomedica's commercial GMP manufacturing capabilities. We are pleased with how the partnership is progressing and excited by the clinical progress to date. The agreement today signals our commitment to the efficient ongoing development of this much needed product for patients with Parkinsons disease.

We are now at a stage in the partnership where we can determine the manufacturing activities and infrastructure required to support the mid and late-stage development of AXO-Lenti-PD in a way which is compatible with later commercialisation and we look forward to this next phase of our partnership.

Pavan Cheruvu, Chief Executive Officer at Axovant Gene Therapies, said: This Agreement with Oxford Biomedica means that together we can continue to advance the development of AXO-Lenti-PD in Parkinsons disease. We are pleased to extend our partnership with Oxford Biomedica, a world leader in lentiviral vector development and manufacturing, as we scale-up AXO-Lenti-PD production to support our Phase 2 and Phase 3 clinical studies and enable commercialization of the product. This marks another mutual accomplishment for our Parkinsons disease program where we expect to enroll the first subject in a randomized, sham-controlled trial in 2021.

About Oxford Biomedica

Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford Biomedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Additionally the group has signed a Clinical and Commercial Supply Agreement with AstraZeneca for manufacture of the adeno based COVID-19 vaccine candidate, AZN1222. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available atwww.oxb.com

About AXO-Lenti-PD

AXO-Lenti-PD is an investigational gene therapy for the treatment of Parkinsons disease that is designed to deliver three genes (tyrosine hydroxylase, cyclohydrolase 1, and aromatic L-amino acid decarboxylase) via a single lentiviral vector to encode a set of critical enzymes required for dopamine synthesis, with the goal of reducing variability and restoring steady levels of dopamine in the brain. The investigational gene therapy aims to provide patient benefit for years following a single administration. The SUNRISE-PD Phase 2 trial is ongoing with dosing completed for all patients in cohort 2, with 6 month safety and efficacy data expected in Q4 2020. Axovant expects to dose the first patient in the Part B randomized, sham controlled study in 2021.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

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Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant Gene Therapies for Manufacture and Supply of AXO-Lenti-PD - PharmiWeb.com

London UK, 27th July 2020 CPI, MicrofluidX and the Cell and Gene Therapy Catapult (CGT Catapult) announced today their collaboration in a project to develop bioprocessing technology for the rapid scale-up of cell and gene therapies.

The technology has the potential to overcome a major bottleneck in the development of these novel treatments, and reduce the time and costs associated with bringing such therapies to market.

Significant advances have been made in recent years in the use of cell and gene therapies in disease areas with unmet clinical needs. However, reliable methods are still required to scale up the manufacture of these complex technologies to commercial levels. Cell and gene therapies are produced from inherently variable living cells. As such, it is highly challenging to achieve consistent performance at different scales, which can lead to prolonged development times. In turn, this can significantly raise the cost of these therapies upon entry to the market.

The microfluidic cell culture technology being developed by MicrofluidX will provide manufacturers of cell and gene therapies with fine process control throughout development, ensuring consistent quality. The technology can be used to optimise cell characteristics and growth conditions early in development, before rapidly transitioning to large-scale manufacturing without the need to invest time in redesigning processes. Crucially, using microfluidics greatly reduces the consumption of expensive reagents, cutting down overall development costs. MicrofluidX recently closed an initial funding round raising 1.4 million for its microfluidic platform. The company is now working with CPI and CGT Catapult to secure further funding and validate its prototypes.

CPI is an independent technology innovation centre and founding member of the UK Governments High Value Manufacturing Catapult. CPIs state-of-the-art facilities provide expertise and advanced equipment for developing GMP-compliant bioprocessing technology. In addition, CPI has drawn from its extensive experience in securing public funding to help MicrofluidX secure 500k of grant funding from Innovate UK for development of the microfluidic bioprocessing platform.

CGT Catapult have more than 230 experts in the industrialisation, manufacturing and clinical adoption of cell and gene therapies, and support industry and academic partners to develop and commercialise these transformative medicines. In this collaboration, the organisation will support MicrofluidX to implement, test and optimise the microfluidics platform, utilising the technology and expertise at the CGT Catapult development centre laboratories in London.

Dr Antoine Espinet, Founder and CEO, MicrofluidX, said:

We are excited to be working with CPI and the Cell and Gene Therapy Catapult on the development of our innovative microfluidics platform. Our technology will cut the time and costs required to bring cell and gene therapies to market, improving access to these novel treatments.

Lucy Foley, Director of Biologics, CPI, said:

We look forward to working with MicrofluidX, following our successful grant application. This technology could play an important role in the future development of cell and gene therapies, and our expertise in the manufacturing of biologics will help to ensure that the technology is market-ready as quickly as possible.

Matthew Durdy, CEO, CGT Catapult, commented:

We are delighted to be supporting the development of this microfluidic bioprocessing platform, technology which shows significant promise for scaling up cell and gene therapy manufacture. The Cell and Gene Therapy Catapult is looking forward to working with MicrofluidX and CPI, innovating together to overcome barriers in the UK industry.

About CPI

CPI works with partners to translate inventions into products and processes that enhance health and wellbeing, protect and improve our environment and increase productivity across industries. With a deep understanding of technology fore-sighting, innovation processes and funding, outstanding technical expertise and industry-relevant assets, we enable the accelerated development of transformational products and processes that have the potential to disrupt and revolutionise markets. We also engage in incremental technological innovation that allows established products and processes to be optimised for better performance and efficient manufacture. Through the breadth of our technology platforms, we support our partners across many diverse markets, including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation. http://www.uk-cpi.com

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 230 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.

About MicrofluidX

MicrofluidX is tackling the problems of process control, scalability, and cost associated with cell bioprocessing, in particular for autologous cell and gene therapy. Its automated, closed technology allows biologists to easily carry out process development by running dozens of cell culture conditions in parallel with extreme process control, and to scale up seamlessly up to several billion cells for manufacturing at a fraction of the current costs. https://www.microfluidx.co.uk/

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CPI, the Cell and Gene Therapy Catapult and MicrofluidX announce development of technology to rapidly scale up cell and gene therapy manufacture -...

ATLANTA, July 30, 2020 /PRNewswire/ --Expression Therapeutics has announced the appointment of Bill Swaney as the Vice President of Manufacturing. He comes to Expression Therapeutics from the Cincinnati Children's Hospital Medical Center where he was the Director of the Vector Production Facility & Viral Vector Core. Mr. Swaney is an internationally recognized expert in GMP cell and gene therapy manufacturing and has conducted over 70 GMP production runs for academic and commercial clients.

"We are pleased to welcome Bill, a pioneer in cell and gene therapy manufacturing, to Expression Therapeutics. Under his leadership, we now have a complete manufacturing team, making us one of the few biotechnology companies with its own therapeutic pipeline and in-house manufacturing, with the capability to provide CDMO services to commercial clients," said Mohan Rao, Ph.D., CEO of Expression Therapeutics.

Expression Therapeutics has also announced today the construction of a 43,000-sq ft manufacturing facility in Cincinnati, Ohio. The facility will manufacture lentiviral (LV), retroviral (RV), and adeno associated viral (AAV) GMP vectors,with a mix of 30-180 liter runs in cell stacks and up to 1,000 liter runs in bioreactors, and will have the capability to manufacture up to 100 GMP vector products per year. Additionally, it provides the necessary infrastructure to fulfill Expression Therapeutics' ex vivo cell processing and recombinant protein production needs. Expression Therapeutics is using prefabricated PODs from G-CON Manufacturing, Inc. for its ISO Class 7 cleanroom suites.

"We decided to utilize advanced pre-built modular cleanrooms from G-CON to accelerate our buildout and commence vector manufacturing this year. With vector GMP manufacturing backlogs today typically exceeding 18 months, we wanted to bring on additional capacity as soon as possible to serve clients," said Bill Swaney, Vice President of Manufacturing for Expression Therapeutics.

Expression Therapeutics is a biotechnology company based in Atlanta and Cincinnati. The current therapeutic pipeline includes advanced gene therapies for hemophilia, neuroblastoma, T-cell leukemia/lymphoma, acute myeloid leukemia (AML), and primary immunodeficiencies such as hemophagocytic lymphohistiocytosis (HLH).

For manufacturing inquiries, please contact Bill Swaney at wswaney@expressiontherapeutics.com.

For all other inquiries, please contact:Ashley WalshDirector of Corporate DevelopmentExpression Therapeutics1860 Montreal RoadTucker, Georgia 30084awalsh@expressiontherapeutics.com+1 312.637.2975

View original content to download multimedia:http://www.prnewswire.com/news-releases/expression-therapeutics-announces-bill-swaney-as-vp-of-manufacturing-and-the-construction-of-cell-and-gene-therapy-manufacturing-301103194.html

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Expression Therapeutics Announces Bill Swaney as VP of Manufacturing and the Construction of Cell and Gene Therapy Manufacturing - BioSpace

As more knowledge is revealed about the genetic underpinnings of cancers, cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients.

The development of chimeric antigen receptor T cell (CAR-T cell) therapiessuch as Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel)and their success in combating hematological malignancies, has paved the way for a surge in investment in CGT, especially adoptive cellular transfer (ACT), in oncology. While in the beginning, we were somewhat limited to CAR-T monotherapies anchored in single antigen targets for CD19-expressing lymphomas and leukemias, research has grown to include expanded and multi-targeting modalities, including additional adoptive cell therapy immune cell vehicles (e.g. NK cells, macrophages, dendritic cells, CD 4+ T cells, etc.). Therefore, it is likely CAR-T cells may be used as both monotherapy, or in combination with novel agents.

Estimates as of February 2020 suggest there are more than 1,000 CGT trials globally, with nearly 600 of those in oncology. Whats more, recent market intelligence projects the global CGT market will continue to rise at a compound annual growth rate of 36.25 percent between 2019 and 2025. The investment in oncology emphasizes the importance of developing innovative and accelerated ways to deliver CGT trials and address the challenges of scaling to commercialization. As such, the demand for understanding how to solve these challenges will continue to increase over the next decade.

The success of CGT has transformed the delivery of clinical trial services, requiring the design of new workflows, processes, and tools to address the nuances and complexities of how CGT trials are executed compared to traditional trials. As the industry evolves, the next generation of adoptive cellular transfer products will move closer to becoming a front-line treatment, as opposed to being limited to relapsed or refractory patients, and will have improved safety and durability of response. Developing improved investigational products requires the use of laboratory services to better identify targets and biomarkers, such as advancing polymerase chain reaction (PCR) and liquid biopsy techniques.

Here, we outline the challenges in designing and executing oncology CGT clinical trials and potential solutions to those complexities.

Challenges in designing and executing CGT clinical trials

Cell therapies are living medicines, with many being autologous, requiring each patient sample to have its own process. This personalization creates a more complex development cycle than other biologic drugs. One of the main challenges in this approach is developing well-defined characteristics or attributes (i.e., cell phenotype of functional measurements) that are well correlated with outcomes for these investigational products, as there are many causes of variability. For example, there may be differences in cells from donor to donor, which can make it difficult to determine which factors drive efficacy and safety. Notably, with CAR-T therapies, significant side effects include cytokine release syndrome (caused by the production of a large number of inflammatory molecules by CAR-T cells) and neurotoxicity, both of which are related to therapeutic efficacy. New characteristic safety profiles could emerge, which need specific considerations on how to manage patients.

Moreover, as biotech companies start to move toward solid tumor targets, the treatment of patients with advanced solid tumors has become more dependent on tissue biomarkers to help guide management decisions. As a result, the ability to obtain tissue for the production or expansion of cell therapies adds another burden. Further, targeted therapies are associated with superior clinical outcomes, but to obtain updated biomarkers and targets, large biopsy specimens are often needed. This is not always feasible, either because lesions are not safely accessible to a surgeon or an interventional radiologist, or because the patient declines further invasive procedures.

Allogeneic therapies, or those using cells from healthy donors, may avoid some complexities of modifying a patients own cells. For example, Gracell Biotechnologies recently presented preliminary results of a first-in-human, universal CAR-T therapy, GC027which targets CD7 on malignant T cellsfor treating adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia. The ability to produce hundreds of viable cells for multiple infusions can overcome issues related to the time it takes to manufacture T-cells, costs to generate a product for each patient, failures in the ability to generate a product from a patients immune cells, and the heterogeneity of T-cell products. However, allogeneic approaches will need to circumnavigate challenges in tissue-matching, which means that human leukocyte antigen typing becomes important in many cases, possibly limiting the target population.

Gene editing and other engineered products, such as T-cell receptor (TCR)-engineered T cells, to treat cancer, are entering into safety and feasibility trials. For example, the first clinical trial using CRISPR-Cas 9 editing to engineer T cells in patients with refractory cancer launched in the fall of 2019. These experimental technologies will raise similar challenges as they move forward through early phase clinical trials.

Conclusion

Over the next 10 years, we will continue to witness significant advances and excitement as CGT saves the lives of patients. First, the industry will conquer the challenges created by the tumor microenvironment, opening opportunities to successfully tackle a broader range of solid tumors. Second, new strategies will emerge to improve the manufacturing and delivery of autologous and allogeneic therapies, improving cost-efficiency. These future advances will be assisted by enhanced diagnostic assays and other tests to improve our understanding of targeting and treating cancer.

Originally posted here:

Navigating Complexity in Oncology Cell and Gene Therapy Clinical Trials - Clinical OMICs News

BOSTON and LONDON, July 30, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will host a conference call and live webcast on Thursday, August 6, 2020, at 8:00 a.m. ET to review business updates and its second quarter 2020 financial results.

A live webcast will be available under "News & Events" in the Investors & Media section of the company's website at http://www.orchard-tx.com. The conference call can be accessed by dialing (866) 987-6504 (U.S. domestic) or +1 (602) 563-8620 (international) and referring to conference ID 7392139. A replay of the webcast will be archived on the Orchard website following the presentation.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Contacts

Investors

Renee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

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Orchard Therapeutics to Webcast Conference Call of Second Quarter 2020 Financial Results - BioSpace

AUSTIN, Texas--(BUSINESS WIRE)--Genprex, Inc. (Genprex or the Company) (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that its Chairman and Chief Executive Officer, Rodney Varner, has participated in a second-round live interview on the Big Biz Show, an emmy-award winning nationally syndicated TV and radio show. A replay of the interview is available for viewing on the Companys website at https://bit.ly/2Esvq05.

During this interview, Mr. Varner discusses:

The Big Biz Show covers current business events, internet-related issues and other hot topics in the business world. The Big Biz Show is seen and heard in over 100 million broadcast TV homes, 150 radio stations in the U.S. and in 175 countries. The Emmy Award winning show was named by TALKERS Magazine as one of the Top 10 Most Influential Financial Shows.

The Big Biz Show can be seen and heard every weeknight on YouTOO America Television Network at 8 p.m. ET, the following morning at 7 a.m. ET, and every weekday on BizTalk Radio at 2 p.m. ET. Additionally, the show can be accessed digitally by visiting BizTVClub.com, where you can watch the Big Biz Show every weeknight at 9 p.m. ET.

To watch Mr. Varners first live appearance on the Big Biz Show in June 2020, visit Genprexs website.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprexs technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Companys lead product candidate, Oncoprex, is being evaluated as a treatment for non-small cell lung cancer (NSCLC). Oncoprex has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for Oncoprex immunogene therapy for NSCLC in combination therapy with osimertinib (AstraZenecas Tagrisso) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Companys web site at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprexs product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Companys future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. These and other risks and uncertainties are described more fully under the caption Risk Factors and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Genprex CEO Participates in a Second-Round Live Interview on the Big Biz Show - Business Wire

No serious adverse events reported through 24 weeks of a 52 week trial.

A single-injection intravitreal gene therapy that can durably express an intraocular anti-VEGF agent could reduce the need for repeated anti-VEGF injections and improve outcomes for patients with neovascular age-related macular degeneration (nAMD).

A team, led by Charles C. Wykoff, MD, PhD, Director of Clinical Research, Retina Consultants of Houston, presented initial findings at theAmerican Society of Retina Specialists (ASRS) 2020 Virtual Meeting on the safety and biological activity of a novel intravitreal anti-VEGF gene therapy in neovascular age-related macular degeneration.

A single-injection intravitreal gene therapy that can durably express an intraocular anti-VEGF agent could reduce the need for repeated anti-VEGF injections and improve outcomes for patients with nAMD.

In the ongoing phase 1 OPTIC study, the investigators are assessing the safety, tolerability, and efficacy of a single intravitreal injection of ADVM-022.

Included in the multicenter, open-label, multiple cohort, dose-ranging study are patients with nAMD who have demonstrated a response to anti-VEGF therapy, who were administered an intravitreal injection of ADVM-022 t 6x10^11 vg/eye for cohort 1 (n = 6) and at 2x10^11 vg/eye for cohort 2 (n = 6).

The investigators evaluated incidence and severity of adverse events, changes in best corrected visual acuity (BCVA), change in central subfield thickness (CST), and the number of aflibercept rescue injections.

Patients in the first cohort previously received frequent anti-VEGF injections, with a mean of 6.2 injections in the preceding 8 months. This patient population also had relatively good baseline BCVA (mean 65.8 ETDRS letters) and a mean baseline CST of 369.2m.

The first 24 weeks of the trial have been positive, with no serious adverse events, dose limiting toxicities or non-ocular adverse events related to ADVM-022 reported.

While ocular inflammation was seen in all patients, it occurred most frequently in the anterior segment and was generally mild and manageable with topical steroids. BCVA was also maintained with a mean change of -2.0 ETDRS letters (90% CI, -9.1-5.1). CST improved with a mean change -52.7m (90% CI, -86.5 to -18.8).

Signs of CNV disease activity on OCT improved or stabilized in the entire patient population, with no rescue injections needed. The study will continue up to 52 total weeks.

ADVM-022 is designed to provide sustained therapeutic levels of aflibercept following a single intravitreal injection, the authors wrote. Patients in cohort 1 of OPTIC treated with a single injection of ADVM-022 were able to maintain vision and improve anatomical outcomes without receiving any rescue aflibercept injections through week 24.

In a separate study presented at ASRS 2020, researchers showed new data on the treatment burden and vision acuity on anti-VEGF injection patterns for nAMD.

In the study, the investigators reviewed the Level 1 evidence of currently approved anti-VEGF agents, as well as those likely to undergo review by regulatory authorities. The researchers analyzed the anti-VEGF agents and treatment dosing regimen for each study and collected the baseline ETDRS letters, mean number of injections over a 12-month period, and change in ETDRS letters over the course of 12 months.

They analyzed a total of 23 injection regiments from studies involving 6860 eyes, including 8 (31.6%, n = 2165) involving ranibizumab every 4 weeks or pro re nata and 6 (28.6%; n = 1962) involving aflibercept dosed every 4 or 8 weeks.

The study, Intravitreal Gene Therapy for Neovascular AMD With ADVM-022: Results of the Phase 1 OPTIC Trial, was published online by ASRS 2020.

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Ongoing Trial Assesses New Anti-VEGF Gene Therapy Injection for nAMD - MD Magazine

According to the latest report published by PMR, the Cancer Gene Therapy market is anticipated to grow at a steady pace over the forecast period (2019-2029). The report sheds light on the various trends and restraining factors that are expected to shape the growth of the Cancer Gene Therapy in the upcoming years. The report ponders over the various parameters that are expected to impact revenue generation, sales, and demand for the Cancer Gene Therapy in the various regional markets.

According to the study, the Cancer Gene Therapy market is likely to attain a market value of ~US$ XX by 2019 and grow at a CAGR of ~XX% during the assessment period. The market study introspects the competition landscape of the Cancer Gene Therapy market and highlights the key developments and technological innovations witnessed in the current Cancer Gene Therapy market landscape.

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Key findings of the Cancer Gene Therapy market report:

Cancer Gene Therapy Market Segmentation

The report dissects the Cancer Gene Therapy market into different segments to provide a fair understanding of the different aspects of the Cancer Gene Therapy market.

The regional analysis of the Cancer Gene Therapy market sheds light on the growth prospects of the Cancer Gene Therapy market in different regions. The current market trends, the impact of regulatory policies, market share, size, and value of each regional market are presented in the report supported by easy-to-understand graphs and tables.

Some of the major companies operating in the global cancer gene therapy market are Cell Genesys, Advantagene, GenVec, BioCancell, Celgene and Epeius Biotechnologies. Other leading players in cancer gene therapy market include Introgen Therapeutics, ZIOPHARM Oncology, MultiVir and Shenzhen SiBiono GeneTech

Key points covered in the report

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Key Questions Related to the Cancer Gene Therapy Market Addressed in the Report

Why Choose PMR?

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Increasing Government Investments and Favorable Policies to Aid the Growth of the Cancer Gene Therapy Market2020 - Owned

With reliable and impactful research methodologies, PMR provides critical information pertaining to the growth of the global Cancer Gene Therapy market. Our team of analysts monitor the ongoing developments within the Cancer Gene Therapy space and provide an unbiased assessment of the global Cancer Gene Therapy market. The data included in the report are procured from reliable and trustworthy primary and secondary sources.

According to the findings of the report, the value of the global Cancer Gene Therapy market in 2018 was ~US$ XX (Mn/Bn) and expected to attain a value of ~US$ XX (Mn/Bn) by the end of 2029. In addition, the report reveals that the global Cancer Gene Therapy market is likely to grow at a CAGR of XX% during the forecast period (2019-2029).

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Some of the leading companies profiled in the market study include:

The Cancer Gene Therapy market report provides an extensive analysis of the different product types including:

The presented market study includes a brief introduction of the Cancer Gene Therapy market to enhance the reading experience of our users. Further, a thorough quantitative and qualitative analysis of each of these segments is provided in the report along with graphs, tables, and figures to support the data.

Some of the major companies operating in the global cancer gene therapy market are Cell Genesys, Advantagene, GenVec, BioCancell, Celgene and Epeius Biotechnologies. Other leading players in cancer gene therapy market include Introgen Therapeutics, ZIOPHARM Oncology, MultiVir and Shenzhen SiBiono GeneTech

Key points covered in the report

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Key information drawn from the Cancer Gene Therapy market study

The market report aims to address the following queries:

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Consumer Demand for Eco-friendly Products Set to Boost the Prospects of the Cancer Gene Therapy Market2020 - Owned

NEW YORK, July 27, 2020 /PRNewswire/ -- Report Scope:The scope of this study encompasses an investigation of the markets cell and gene therapy tools such as GMP proteins, media, cell separation and activation reagents, viral and non-viral, cytokine release syndrome monitoring products, GMP antibodies, leukapheresis instrumentation, immunoassays (multiplex and singleplex) and bioreactors.The analyst examines each tool type, determines its current market status, examines its impact on future markets, and presents forecasts of growth over the next five years.

Read the full report: https://www.reportlinker.com/p05938974/?utm_source=PRN

Technological issues, including the latest trends, are discussed. The analyst examined the industry on a worldwide basis, from both application and demand perspectives, in the major regions of the world.

Report Includes:- 77 data tables- An overview of the global market for immunoassay-based cell and gene therapy tools, and reagents within the life sciences industry- Analyses of the global market trends, with data corresponding to market size for 2017-2019, and projections of compound annual growth rates (CAGRs) through 2024- Information about in vitro diagnostics (IVD), its background and importance of IVD testing- Discussion on prevalence of infectious disease, metabolic disorders and chronic ailments as drivers of immunoassay testing market- Description of recent technologies such as chemiluminescent immunoassays (CLIA), fluorescent immunoassays, multiplex assays and rapid diagnostic technologies- Evaluation of market potential for immunoassay-based cell and gene therapy tools and reagents, current market size and market forecast, and market share analysis of the leading players engaged- Patent review and new developments, R&D efforts, industrial changes with emphasis on recent investments, and current state of the immunoassay technology- Company profiles of the key market participants, including Bio-Rad Laboratories, Cytiva Life Sciences, Luminex Corp., Millipore Sigma, Thermo Fisher Scientific and STEMCELL Technologies

Reasons for Doing this Study:Gene and cell therapy are emerging as important tools to treat human health.Techniques such as CAR-T therapy have emerged as key ways of treating many different types of cancers.

The promise of gene therapy using technologies such as CRISPR is starting to be realized in clinical trials, and markets are scaling up to treat other diseases as well, particularly rare gene- based diseases.As these therapies are coming to the fore, a new market for tools to develop these therapies using standard methodologies is emerging.

This report will cover what those tools are, how they impact the larger life science tools market, and how they will evolve over the next five years.

Read the full report: https://www.reportlinker.com/p05938974/?utm_source=PRN

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cell and Gene Therapy Tools, and Reagents: Global Markets - cnweekly

For Immediate Release: July 24, 2020

Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.

Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patients own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Were seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine.

MCL is a rare form of cancerous B-cell non-Hodgkins lymphoma that usually occurs in middle-aged or older adults. In patients with MCL, B-cells, a type of white blood cell which help the body fight infection, change into cancer cells that start to form tumors in the lymph nodes and quickly spread to other areas of the body.

Each dose of Tecartus is a customized treatment created using a patients own immune system to help fight the lymphoma. The patients T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells. These modified T cells are then infused back into the patient.

The safety and efficacy of Tecartus was established in a multicenter clinical trial of 60 adults with refractory or relapsed MCL who were followed for at least six months after their first objective disease response. The complete remission rate after treatment with Tecartus was 62 percent, with an objective response rate of 87 percent.

The label carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR-T cells causing high fever and flu-like symptoms, and for neurologic toxicities. Both CRS and neurologic toxicities can be fatal or life-threatening. The most common side effects of Tecartus include serious infections, low blood cell counts and a weakened immune system. Side effects from treatment usually appear within the first one to two weeks after treatment, but some side effects may occur later.

Because of the risk of CRS and neurological toxicities, Tecartus is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The risk mitigation measures for Tecartus are identical to those of the current REMS Program for another CAR-T therapy, Yescarta.

To further evaluate the long-term safety of Tecartus, the FDA is also requiring the manufacturer to conduct a post-marketing observational study involving patients treated with Tecartus.

Tecartus was approved under the Accelerated Approval pathway and was granted Priority Review and Breakthrough Therapy designations. Tecartus also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The Tecartus application was reviewed using a cross-agency approach. The clinical review was coordinated by the FDA's Oncology Center of Excellence, while CBER conducted all other aspects of review and made the final product approval determination. The FDA remains committed to supporting safe and effective treatment options that have the potential of providing lifesaving results.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

07/24/2020

Link:

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL - FDA.gov

Impact Analysis of Covid-19

The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

Get Sample PDF Including COVID19 Impact Analysis Of Personalized Gene Therapy Treatments for Cancer, https://www.coherentmarketinsights.com/insight/request-pdf/60

The Personalized Gene Therapy Treatments for Cancer Market is expected to have a highly positive outlook for the next five years 2020-2027 according to a recently released Personalized Gene Therapy Treatments for Cancer Market research report. The report has been added to his large database by Coherent Market Insights. This report is a guide that covers key strategic developments of the market including acquisitions & mergers, new technology launch, agreements, partnerships, collaborations & joint ventures, research & development, technology, and regional expansion of major participants involved in the market on the global and regional basis.

It also going to elaborate the opportunities out there in micro niches for stakeholders to take a position, step by step investigation of the competitive landscape and even commodity professional services of famous players which include Amgen, Inc., SynerGene Therapeutics, Inc., Chengdu Shi Endor Biological Engineering Technology Co., Ltd., Cold Genesys, Inc., Takara Bio, Inc., Bellicum Pharmaceuticals, Inc., Ziopharm Oncology, Inc., OncoSec Medical, Inc., Sevion Therapeutics, Inc., and Burzynski Clinic.

The key features of the Personalized Gene Therapy Treatments for Cancer Market report 2020-2027 are the organization, extensive amount of analysis, and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the market.

The comprehensive value chain analysis of the Personalized Gene Therapy Treatments for Cancer market will assist in attaining better product differentiation, along with a detailed understanding of the core competency of each activity involved. The market attractiveness analysis provided in the report measures the potential value of the Personalized Gene Therapy Treatments for Cancer providing business strategists with the latest growth opportunities.

Questions have been answered at Personalized Gene Therapy Treatments for Cancer Market report:

Economy Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, along with Strategies) The length of the global Personalized Gene Therapy Treatments for Cancer market opportunity? How share promote Personalized Gene Therapy Treatments for Cancer their worth from different manufacturing brands? Which will be the niches at which players profiling with thorough plans, financials, and also recent advancements should set a presence? Which will be the anticipated growth rates for your own Personalized Gene Therapy Treatments for Cancer economy altogether and also for every segment inside? Which will be the Personalized Gene Therapy Treatments for Cancer application and types and forecast accompanied closely by producers?

The research report on the Personalized Gene Therapy Treatments for Cancer market evaluates the growth trends of the industry through historical study and estimates future prospects based on comprehensive research. The report extensively provides market share, growth, trends, and forecasts for the period 2020-2027. The market size in terms of revenue (USD MN) is calculated for the study period along with the details of the factors affecting the market growth (drivers and restraints).

Key Topics Covered:

Part 01: Executive SummaryPart 02: Scope Of The ReportPart 03: Research MethodologyPart 04: Market Landscape Market Ecosystem Market Characteristics Market Segmentation Analysis

Part 05: Market Sizing Market Definition Market Sizing 2020 Market Size And Forecast 2020-2027

Part 06: Five Forces Analysis Bargaining Power of Buyers Bargaining Power of Suppliers Threat of New Entrants Threat of Substitutes Threat of Rivalry Market Condition

Part 07: Customer LandscapePart 08: Regional Landscape Geographical Segmentation Regional Comparison Americas Market Size And Forecast 2020-2027 EMEA Market Size And Forecast 2020-2027 APAC Market Size And Forecast 2020-2027

Part 09: Decision FrameworkPart 10: Drivers And Challenges Market Drivers Market Challenges

Part 11: Market TrendsPart 12: Vendor Landscape Overview Landscape Disruption Vendors Covered Vendor Classification Market Positioning Of Vendors

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Covid 19 Analysis On Personalized Gene Therapy Treatments for Cancer Market 2020 Top 10 Countries Exclusive Data, Demand, Share and Growth Analysis by...

The UKs capability to manufacture vaccines has received a substantial boost today (Thursday 23 July), as the government announces an additional 100 million to ensure that any successful COVID-19 vaccine can be produced at scale in the UK.

The investment will fund a state-of-the-art Cell and Gene Therapy Catapult Manufacturing Innovation Centre to accelerate the mass production of a successful COVID-19 vaccine in the UK. Due to open in December 2021, the Centre will have the capacity to produce millions of doses each month, ensuring the UK has the capabilities to manufacture vaccines and advanced medicines, including for emerging diseases, far into the future.

Located in Braintree, Essex, the government initiative will upgrade an existing facility to create a fully-licensed manufacturing centre. Doing so will increase the UKs ability to respond to diseases like coronavirus and to prepare for potential future pandemics while creating new, high-skilled jobs to fuel the UKs economic recovery.

The new centre will complement the Vaccines Manufacturing and Innovation Centre (VMIC), which is currently under construction in Oxfordshire thanks to a 93 million investment from the government. Once complete next year, the facility will have the capacity to produce enough vaccine doses to serve the entire UK population at scale.

While the centre is under construction, the government has invested an additional 38 million to establish a rapid deployment facility, opening later this summer, that will support efforts to ensure a successful vaccine is widely available to the public as soon as possible.

Business Secretary Alok Sharma said:

We are taking all necessary steps to ensure we can vaccinate the public as soon as a successful COVID-19 vaccine becomes available.

This new Cell and Gene Therapy Catapult Manufacturing Innovation Centre, alongside crucial investment in skills, will support our efforts to rapidly produce millions of doses of a coronavirus vaccine while ensuring the UK can respond quickly to potential future pandemics.

To support these enhanced vaccine manufacturing capabilities, the government will invest an additional 4.7 million for the Cell and Gene Therapy Catapult to ensure that the UK has the best skills and expertise through the development of virtual and physical national Centres for Advanced Therapies Training and Skills, in partnership with industry.

The facilities and online training platform will provide industry-standard skills and experience in advanced gene therapy and vaccine manufacturing, including sterile techniques for Good Manufacturing Practice which is the minimum standard that a medicines manufacturer must meet in their production processes.

Employment in the cell and gene therapy sector is predicted to reach over 6,000 jobs by 2024, with over 3,000 in manufacturing and bioprocessing.

Matthew Durdy, CEO, Cell and Gene Therapy Catapult commented:

This commitment from government through the Vaccines Taskforce will enable continued growth and productivity in the cell and gene therapy sector, as well as providing vital resource for vaccine manufacturing and economic recovery from the COVID-19 pandemic.

We are delighted to be able to deploy the specialist capabilities of the Cell and Gene Therapy Catapult in such an important initiative. Accelerating the availability of COVID-19 vaccines, increasing skills and employment, and facilitating growth of the advanced medicines industry will make a valuable contribution to the recovery of the economy.

Kate Bingham, Chair of the Vaccines Taskforce said:

Todays announcement is another important milestone for us. The work of the Vaccines Taskforce is focused on protecting the UK against COVID-19 through vaccination as quickly as possible.

In order to vaccinate our high-risk populations at the earliest opportunity, the government has agreed to proactively manufacture vaccines now, so we have millions of doses of vaccine ready if they are shown to be safe and effective. The acquisition of this state-of-the-art manufacturing centre will not only help us with this, but also ensures we are well-placed as a country to be able to cope with any pandemics or health crises in the future.

As well as addressing the immediate need to produce a COVID-19 vaccine, the new Cell and Gene Therapy Centre, developed with Innovate UK and the Cell and Gene Therapy Catapult, will be at the forefront of the growing UK cell and gene therapy industry. Scientists and researchers based in the centre will accelerate the time taken for new treatments to be delivered to patients by developing cutting-edge therapies to treat life changing diseases, such as diabetes, heart disease and cancer.

The UK is at the forefront of international efforts to research and develop a COVID-19 vaccine and has provided 131 million funding to University of Oxford and Imperial College London to accelerate their work on 2 vaccine candidates.

This follows news on Monday (20 July) that the government secured early access to 90 million vaccine doses from the BioNTech/Pfizer alliance and Valneva as part of its strategy to build a portfolio of promising new vaccines to protect the UK from COVID-19. In addition, treatments containing COVID-19-neutralising antibodies have been secured from AstraZeneca to protect those who cannot receive vaccines.

The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation.

With more than 230 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.

The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit the Cell and Gene Therapy Catapult or Innovate UK.

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Over 100 million cash boost to manufacture millions of doses of COVID-19 vaccine - GOV.UK

SEATTLE, July 27, 2020 /PRNewswire/ --AGC Biologics, a Global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that they will acquire the majority of the share capital of Molecular Medicine S.p.A. ("MolMed") on July 31, 2020. MolMed is a biotechnology company focused on research, development, production and clinical validation of cell and gene therapies for the treatment of cancer and rare diseases. AGC Biologics is now one of the very few CDMO's in the world offering both plasmid production and end-to-end cell and gene therapy services.

Cell and gene therapy is an innovative and rapidly growing therapeutic field that aims to treat diseases that do not have adequate treatments to date. Approximately 1,000 clinical trials are underway worldwide, with some products receiving market authorization in the last few years and approximately 50 new therapies expected to be authorized by 2030. Thanks to its two commercially authorized facilities, MolMed offers GMP services for the development and production of cell and gene therapies. MolMed brings deep experience and expertise in providing development and GMP manufacturing services for viral vectors and genetically modified cells, from the preclinical phase through commercial demand.

"While we work hard to take care of each other and our customers during this very challenging and uncertain time, it's also important that we ensure the continued growth of our company," says AGC Biologics CEO Patricio Massera. "AGC Biologics is committed to continuously expanding our offerings and growing our capacity to serve all the needs of current and future customers. We are very pleased to be adding MolMed and its great cell and gene therapy capabilities and track record to AGC Biologics' global CDMO service offerings."

About AGC Biologics:AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,000 employees worldwide. AGC Biologics' global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.

AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial mammalian and microbial production. Integrated service offerings include plasmid (GMP pDNA) manufacturing, cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1 Expression System for mammalian production. Learn more at http://www.agcbio.com.

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AGC to Complete the Acquisition of MolMed on July 31, 2020 - NBC Right Now

When you think of a typical meal in the US South, you will likely recall the rich, hearty dishes that have immortalized themselves in the food culture of the Southern States. Fried chicken, mashed potatoes, gravy, macaroni and cheese; its all mouth-watering stuff, but of course there is a catch. Foods like these are loaded with fats and, as a result, calories. A diet heavy in such dishes can have a detrimental impact on your health and wreak havoc on your heart and circulatory system.

The CDC has highlighted the fact that, as a result of such diets, various forms of heart disease kill more Southerners than any other disease. One such example can be found in the fact that Southern Counties record a much higher death rate for diseases such as strokes than the rest of America. Strokes are fast acting and deadly, occurring every 40 seconds in the United States, claiming a life every four minutes. Thats 140,000 deaths a year, the third highest total from any disease. Globally, strokes are an epidemic and the second highest cause of death.

While a satisfying cure remains elusive, advances in biotechnology are offering new hope to the millions of people who experience strokes.

What is a stroke?

A stroke is triggered when a blood vessel in the brain gets blocked or bursts. Striking when the blood supply to part of the brain is cut off, a stroke deprives brain cells (neurons) of their critical supply of oxygen. If neurons go without oxygen for more than a few minutes, they start to die by the millions, so it is critical to act fast if you see any signs of onset. Typically a patient will exhibit distinct physical symptoms such as facial drooping, inability to raise arms and slurred speech, and the stroke usually occurs in one of two ways. During an ischemic stroke, the blood supply is stopped by a clot in a blood vessel, which accounts for roughly 85 percent of cases. A hemorrhagic stroke, in contrast, occurs when a blood vessel within the brain becomes weak and bursts.

Regardless of which scenario occurs, a stroke poses a serious threat to the health of a patient. A constant blood supply is the single most essential component in keeping the brain operational. Every cell within the body relies on oxygen from the blood in order to make energy and function, and the brain is a very oxygen-hungry organ. Despite its relatively small size, your brain requires 20 percent of your total oxygen supply. The damage can, therefore, be severe and irreversible if the blood supply to the brain is cut off for more than 10 minutes. For this reason, it is essential that current stroke therapies are administered quickly, but many stroke victims are still likely to suffer long-term consequences that can take years to correct. Consequently, scientists work tirelessly to find better therapies for stroke patients.

Treatment shortfalls and arduous recovery

The need for new and innovative therapies for stroke patients is driven by limitations in currently approved medical interventions. There are two current drug regimens used to treat strokes. Anticoagulants such as warfarin break up existing bloodclots, preventing the most common types of strokes. Antiplatelets such as clopidogrel (Plavix) can be used to help prevent blood clots from forming altogether. But neither one of these drug types repairs the brain damage often associated with strokes.

Additionally, surgery can be performed to treat brain swelling and help prevent further bleeding, but the lingering problem is that patients are still often left with long-term issues after suffering a stroke. Recovery can be a long and arduous process because of the difficulty the brain has in replacing the cellular connections that are lost when neurons die as a result of a stroke. When the cells die, the functions they are responsible for are lost. Regaining those functions often involves a long course of reablement therapies aimed at teaching the brain to build new connections and re-learn skills that were lost after a stroke.

Why gene therapy provides promise

Research indicates that in many instances, a brain can heal itself after a stroke. Cells that are damaged are not beyond repair. They can regenerate. Researchers in the field are pushing for pharmaceutical options to help speed up this regeneration of the lost network of brain cells. This is where gene therapy could make a real difference. Gene therapy offers scientists the tools required to genetically reprogram cells to help speed up the regeneration process during stroke recovery.

The use of gene therapy is still very much in its infancy, with a lot of research underway to ensure the technology can be implemented safely and effectively. Direct administration of DNA into the brain offers the advantage of producing high concentrations of therapeutic agents in a relatively localized environment. Gene transfer also provides longer duration of effect than traditional drug therapy. Recent studies have shown a lot of promise.

In one such study, researchers at Penn State University developed a gene therapy platform using a gene called neurogenic differentiation 1 (NeuroD1). The study, which was conducted on mice, investigated the potential of using a retrovirus to deliver NeuroD1 directly into the brains of mice that had suffered from a stroke. Researchers found that the therapy converted glial cells into the neuronal cells that are critical to regenerating lost brain tissue. Mice treated with this novel gene therapy not only lost less brain tissue but also showed a significant improvement in motor function. According to the leader of the research team, Prof Gong Chen:

The biggest obstacle for brain repair is that neurons cannot regenerate themselves. Many clinical trials for stroke have failed over the past several decades, largely because none of them can regenerate enough new neurons to replenish the lost neurons. I believe that turning glial cells that are already present in the brain into new neurons is the best way to replenish the lost neurons.

In another study from Florida Atlantic University, a research team explored the potential of using a protein called granulocyte-colony stimulating factor (G-CSF) to give cells in the brains of mice the genetic push they needed to trigger regeneration after stroke. The results were, once again, very positive, with treated mice showing an improvement in prognosis after stroke. The cells were more resistant to damage-induced death and this significantly improved behavioral functions in treated mice.

This therapy provides another promising avenue, but study co-author Prof Howard Prentice emphasized the need for further investigation:

Future research will need to focus on uncovering the complete mechanisms by which GCSF retains the ER and mitochondrial homeostasis.

While Prentice underscored the preliminary nature of this research, the data generated so far indicate gene therapies are extremely promising avenues for improving the lives of stroke patients. And just last month, a team at the University of San Diego Medical School released a study showing that just a single treatment that inhibits a gene known as PTB resulted in the disappearance of symptoms associated with Parkinsons disease and other neurodegenerative impairments.

Its my dream to see this through to clinical trials, to test this approach as a treatment for Parkinsons disease, but also many other diseases where neurons are lost, such as Alzheimers and Huntingtons diseases and stroke, said Xiang-Dong Fu, head of the research team. And dreaming even bigger what if we could target PTB to correct defects in other parts of the brain, to treat things like inherited brain defects?

The positive nature of Xiang-Dong Fus outlook is something we can all feel inspired by. At present, the road to recovery for stroke patients is long and their quality of life can suffer. But we have the potential to kick-start that recovery and help the brain rebuild the precious connections that enable stroke victims to lead healthier lives. For now, theres no easy answer; preventing a stroke remains a better option than treating and recovering from one. But the constant influx of advances in gene therapy could provide a quicker route to repairing the severe damage when it does occurdramatically boosting the quality of life for millions of people.

Sam Moxon has a PhD in regenerative medicine and is currently involved in dementia research. He is a freelance writer with an interest in the development of new technologies to diagnose and treat degenerative diseases. Follow him on Twitter @DrSamMoxon

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Strokes often deadly but gene therapy offers hope to rebuild critically damaged brain cells - Genetic Literacy Project

Global Gene Therapy for Age-related Macular Degeneration (COVID-19) Market Report 2020 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026 (Based on 2020 COVID-19 Worldwide Spread)

The Gene Therapy for Age-related Macular Degeneration market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, the impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

>>>Download Sample PDF (including COVID19 Impact Analysis, full TOC, Tables and Figures) of Tablet PC (COVID-19) Market: https://industrystatsreport.com/Request/Sample?ResearchPostId=11998&RequestType=Sample

Latest research report on Gene Therapy for Age-related Macular Degeneration Market delivers a comprehensive study on current market trends. The outcome also includes revenue forecasts, statistics, market valuations which illustrates its growth trends and competitive landscape as well as the key players in the business.

Macular degeneration is a condition in which, macula, a part of the retina, gets damaged or deteriorated. This condition usually affects individuals who are aged 50 years and above and therefore, it is called age-related macular degeneration (AMD). AMD is the leading cause of vision loss and is directly related to the advancement of age. But smoking also plays a vital role in causing AMD. AMD is characterized by the presence of a blurred area near the center of vision that leads to distorted vision. There are two different types of AMD, including dry (atrophic) AMD (dAMD) and wet (neovascular/exudative) AMD (wAMD). The dAMD is the most common type of AMD and accounts for almost 80%-90% of the overall AMD cases.

It has been observed that age-related macular degeneration (AMD) is one of the major causes for vision loss and is characterized by the formation of a blurred area near the center of vision, a condition that mostly affects the geriatric population. According to the CDC, almost 2 million individuals in the US suffer from AMD and by 2050, this number will reach more than 5 million. This will subsequently demand the need for the development of innovative treatments for AMD, driving the markets growth.

The market research analysts have predicted that with the introduction of techniques such as fluorescein angiography, the global age-related macular degeneration market will register a CAGR of more than 7% by 2020. With the unavailability of FDA-approved treatment for dry AMD (dAMD) and the treatment of wet AMD (wAMD) involving the need of intravitreal injections for an indefinite period, gene therapy is emerging as the most-efficient approach for the treatment of age-related macular degeneration (AMD).

According to this pipeline analysis report, most of the gene therapy molecules in the pipeline are being developed for wet AMD (wAMD). Our market research analysts have also identified that most of these molecules are in the pre-clinical development stage and a considerable number of molecules have been discontinued from development.

This report focuses on the global Gene Therapy for Age-related Macular Degeneration status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Gene Therapy for Age-related Macular Degeneration development in United States, Europe and China.

The key players covered in this study RetroSense Therapeutics REGENXBIO AGTC

Market segment by Type, the product can be split into Subretinal Intravitreal Unspecified

Market segment by Application, split into Monotherapy Combination Therapy

In this study, the years considered to estimate the market size of Gene Therapy for Age-related Macular Degeneration are as follows: History Year: 2014-2018 Base Year: 2018 Estimated Year: 2019 Forecast Year 2019 to 2025

Market segment by Regions/Countries, this report covers United States Europe China Japan Southeast Asia India Central & South America

The study objectives of this report are: To analyze global Gene Therapy for Age-related Macular Degeneration status, future forecast, growth opportunity, key market and key players. To present the Gene Therapy for Age-related Macular Degeneration development in United States, Europe and China. To strategically profile the key players and comprehensively analyze their development plan and strategies. To define, describe and forecast the market by product type, market and key regions.

For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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Gene Therapy for Age-related Macular Degeneration Market 2020 | Present Scenario and Growth Prospects 2025 - Bulletin Line