Need for a more reliable, accurate and cost-efficient testing platform

VANCOUVER, BC, June 7, 2022 /PRNewswire/ - Microbiome Insights, Inc., a global leader for end-to-end microbiome sequencing and comprehensive bioinformatic analysis,announced today it was awarded an $881,000 contract from Health Canada to develop a testing platform to accurately identify and characterize micro-organisms found in microbial biotechnology products, and predict their interactions that could mask or enhance adverse effects to determine risks to human and environmental health. This contract follows an initial agreement completed in 2021 and is part of Innovative Solutions Canada, a competitive federal funding program for innovators and federal agencies to collaborate and further commercialize new technology.

"Leveraging our expertise in metagenomics and metatranscriptomics, we are excited to continue our collaboration with Health Canada to develop a testing platform that will benefit both regulators and the manufacturers of microbial mixture products," said Dr. Pedro Dimitriu, the Head of Research and Development at Microbiome Insights. "The translation of microbiome science into products is accelerating and with this, there is a real need for a more reliable, accurate and cost-efficient way to determine the quality and safety of these new products."

Products with microbial mixtures have the capacity to perform novel and complex tasks in a diverse array of biotechnology applications, many of which support the goals of sustainability. The testing required for regulatory approval of these products can be costly, often relying on animal testing to understand their toxicity. There are no suitable test methodologies and novel approaches to determine the adverse effects of microbial mixtures.

As part of the Innovative Solutions Canada program, Microbiome Insights is developing a more reliable, accurate, and cost-efficient way to determine the quality and safety of these new products.

About Microbiome Insights Inc.

Microbiome Insights, Inc. is a global leader providing end-to-end microbiome sequencing and comprehensive bioinformatics analysis. The company is headquartered in Vancouver, Canada, where samples from around the world are processed in its College of American Pathologists (CAP) accredited laboratory. Working with clients from pharma, biotech, nutrition, cosmetic and agriculture companies, and world-leading academic and government research institutions, Microbiome Insights has supported over 700 microbiome studies, from basic research to commercial R&D and clinical trials. The company's expert bioinformaticians and data scientists deliver industry-leading insights, including biomarker discovery, machine-learning-based modelling and customized bioinformatics analysis.www.microbiomeinsights.com

Health Canada

Health Canada is the Federal department responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible and works to reduce health risks. Health Canada is committed to improving the lives of all of Canada 's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle, and effective use of the public health care system.www.canada.ca/en/health-canada.html

Innovative Solutions Canada

Innovative Solutions Canada (ISC) is a competitive federal funding program for innovators and federal agencies to collaborate and further commercialize new technology. It is a key component of the Canadian government's Innovation and Skills Plan, a multi-year plan to make Canada a global innovation leader and prepare Canadians to succeed in tomorrow's economy. http://www.ic.gc.ca/eic/site/101.nsf/eng/home

SOURCE Microbiome Insights

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Microbiome Insights awarded Innovative Solutions Canada contract by Health Canada to enhance regulatory testing for microbial biotechnology products -...

NEW YORK, June 06, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (NASDAQ: TLSA) ("Tiziana" or the "Company"), a clinical-stage biopharmaceutical company enabling breakthrough immunotherapies via novel routes of administration today announced that its Chief Executive Officer and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will present at the Biotechnology Innovation Organization (BIO) Annual Convention taking place at the San Diego Convention Center, Monday June 13 - Thursday, June 16, 2022. His presentation will be primarily focused on the recent clinical updates on nasal administration of foralumab, a fully human anti-CD3 monoclonal antibody, for treatment of patients with secondary progressive multiple sclerosis. He will also provide an update on the initiation of Phase 1b trial with first-ever oral capsules of foralumab for treatment of patients with mild-to-moderately active Crohns Disease. Company management will also be participating in one-on-one meetings throughout the conference.

Presentation Information

Presenter: Kunwar Shailubhai, Ph.D., Chief Executive Officer and Chief Scientific Officer, Tiziana Life SciencesTitle: Enabling Breakthrough Immunotherapies via Novel Routes of Drug Delivery

Day: Tuesday, June 14thTime: 2:00- 2:15 pm PDTLocation: Theater 1

To register for the conference and schedule a one-on-one meeting with Tiziana Life Sciences management, please visit https://www.bio.org/events/bio-international-convention/registration.

Dr. Shailubhai will also attend the BioNJ 29th Annual Dinner Meeting and Innovation Celebration, gathering and honoring members of New Jerseys life science ecosystem, on Thursday, June 9, 2022 at 4:45 pm EDT. This meeting, taking place at the Hilton in East Brunswick New Jersey, was originally planned for February, and was postponed due to the surge of the Omicron variant.

About BIO and the BIO International ConventionThe Biotechnology Innovation Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. Our mission is to be the champion of biotechnology and the advocate for our member organizationsboth large and small. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. Corporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. We also represent state and regional biotech associations, service providers to the industry and academic centers. Currently there are over 3,000+ international and domestic companies registered to attend BIO 2022 across the biotech industry.

About BioNJFounded in 1994, BioNJ, the New Jersey partner of BIO, has been hard at work in its mission to enhance the climate for life sciences in the State. As the representative of an industry that has the potential to change the course of human health, make our environment cleaner and the foods we eat safer and healthier, BioNJ is single-minded in its commitment to the growth and prosperity of this industry within the state of New Jersey.

About Tiziana Life SciencesTiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tizianas innovative intranasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tizianas two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tizianas technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For further information please contact:

Tiziana Life Sciences:Hana Malik, Business Development and Investor Relations Manager +44 (0) 207 495 2379email:info@tizianalifesciences.com

United States:

Investors:Irina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

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Tiziana Life Sciences to Present at the 2022 Biotechnology Innovation Organization Annual Convention to Discuss Recent Updates to Ongoing Clinical...

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase II SUMMIT trial, assessing the efficacy of combined neratinib, fulvestrant, and trastuzumab in patients with hormone receptor positive, HER2-negative, HER2-mutant metastatic breast cancer, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held in person from June 3-7 in Chicago, IL, and online. The poster, entitled Neratinib + fulvestrant + trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): outcomes and biomarker analysis from the SUMMIT trial, was presented at the Breast Cancer -- Metastatic Poster Session (poster #1028) by Komal L. Jhaveri, MD, FACP, Medical Oncologist at Memorial Sloan Kettering Cancer Center on June 6 at 9:00 a.m. ET.

Earlier genomic analyses from a cohort treated with a combination of neratinib and fulvestrant suggest that resistance to neratinib may occur via mutant allele amplification or secondary HER2 mutations. The addition of trastuzumab to the combination of neratinib and fulvestrant in this trial demonstrated positive durable responses in patients with HR-positive, HER2-mutant MBC who had received prior CDK4/6 inhibitors (CDK4/6i).

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that included a cohort evaluating the efficacy of the triplet combination of neratinib (N), plus fulvestrant (F), plus trastuzumab (T), in patients with HR-positive, HER2-negative, HER2-mutant metastatic breast cancer, as identified by local genomic sequencing, who had previously received CDK4/6 inhibitors. In order to confirm the contribution of neratinib to the combination, a small, randomized cohort comparing neratinib plus fulvestrant plus trastuzumab versus fulvestrant plus trastuzumab versus fulvestrant was also included. A range of HER2 allelic variants was represented in the cohort. Patients who received the triplet regimen were enrolled in the non-randomized cohort and received 240 mg of neratinib per day intramuscularly, 500 mg intravenous fulvestrant on days 1 and 15 of Cycle 1 and then every 4 weeks, 8mg/kg body weight trastuzumab initially and then 6mg/kg every 3 weeks. Patients in the randomized cohort received either a combination of neratinib, fulvestrant, and trastuzumab, or fulvestrant and trastuzumab, or fulvestrant alone in a 1:1:1 ratio. To counter the side effects of diarrhea, loperamide prophylaxis was mandatory for the first two treatment cycles. Patients who were randomized to the combination of fulvestrant and trastuzumab, or fulvestrant alone, could cross over to receive neratinib, fulvestrant, and trastuzumab at progression. Efficacy was assessed using objective response rate (ORR) and clinical benefit rate (CBR). Tumor tissue was retrospectively assessed by central next-generation sequencing (NGS).

The table below summarizes the efficacy of SUMMIT MBC patients who received neratinib plus fulvestrant plus trastuzumab, those who received fulvestrant plus trastuzumab, and those who received fulvestrant alone; and also those who received fulvestrant plus trastuzumab or fulvestrant and then crossed over to neratinib plus fulvestrant plus trastuzumab upon progression. Patients who received neratinib plus fulvestrant plus trastuzumab (non-randomized + randomized) had a 35.3% investigator-assessed objective response rate, 14.3-month duration of response, 41.7% clinical benefit rate, and 8.2-month median progression-free survival. Neratinib appears to be a critical component of the combination therapy, as demonstrated by lack of response in the small cohort of patients treated with fulvestrant or fulvestrant plus trastuzumab, and by response in a subset of those patients upon crossover to neratinib plus fulvestrant plus trastuzumab.

Table: Efficacy Findings from HR+ Metastatic Breast Cancer Patients

Non-randomized +

Randomized

After crossover

Randomized

After crossover

Randomized HR+

HR+

from F+T to

HR+

from F to N+F+T

Prior CDK4/6i

Prior CDK4/6i

N+F+T

Prior CDK4/6i

(N+F+T, n=51)

(F+T, n=7)

(n=4)

(F, n=7)

(n=6)

18 (35.3)

0

1 (25.0)

0

2 (33.3)

1 (2.0)

0

0

0

0

17 (33.3)

0

1 (25.0)

0

2 (33.3)

Best overall response*

25 (49.0)

0

1 (25.0)

0

2 (33.3)

14.3 (6.4NE)

No response

6.2 (NENE)

No response

6.3 (6.26.4)

24 (47.1)

0

1 (25.0)

0

5 (83.3)

8.2 (4.712.7)

3.9 (1.94.1)

8.25 (NENE)

4.1 (1.64.1)

NE

These results suggest that the combination of neratinib, fulvestrant, and trastuzumab together is promising for treating HR+ and HER2-mutated MBC with prior exposure to CDK4/6i across a range of HER2 mutations.

Dr. Jhaveri, an investigator of the trial, said, Patients with hormone receptor-positive, HER2-negative, HER2-mutant metastatic breast cancer who had received prior treatment with CDK4/6 inhibitors demonstrated encouraging clinical activity with durable responses when treated with the triplet combination of neratinib with fulvestrant and trastuzumab. These responses were observed in patients whose tumors harbored a wide spectrum of HER2 mutations, including those with co-occurring HER3 mutations, regardless of ductal or lobular histology, and with a range of HER2 protein expression.

Alan H. Auerbach, Chief Executive Officer, and President of Puma Biotechnology added, HER2 mutations can be readily and accurately identified and are clinically actionable for targeted therapy in metastatic breast cancers. We are very pleased with the updated activity seen with the combination of neratinib plus trastuzumab plus fulvestrant therapy in this heavily pretreated metastatic breast cancer patient population with HER2-mutated disease.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

Important Safety Information Regarding NERLYNX (neratinib) U.S. Indication

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

The most common adverse reactions (reported in 5% of patients) were as follows:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

DRUG INTERACTIONS:

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Puma Biotechnology Presents Outcomes from the Metastatic Breast Cancer Cohort of the SUMMIT Trial at the ASCO 2022 Annual Meeting - Business Wire

Megan Wieser

June 4 2022 7:40 AM| updated June 6 2022 1:48 PM

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EDWARDSVILLE On Friday, May 27, the Illinois Industrial Biotechnology Partnership Act was signed into law by Governor JB Pritzker and establishes the Industrial Biotechnology Public-Private Partnership as a State-sponsored board consisting of specified members to promote and market Illinois as a destination for research, development and commercialization for industrial biotechnology.

The National Corn-to-Ethanol Research Center (NCERC) at Southern Illinois University Edwardsville has been a leading institution for research in industrial biotechnology in Illinois and the United States since its doors opened in 2003. Today, it celebrates the signing of this historic legislation.

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The bill was passed unanimously by both the Illinois House of Representatives and the Illinois Senate with bipartisan support. The Partnership will consist of 12 members, including the Illinois Department of Agriculture, Illinois Department of Commerce and Economic Opportunity, Illinois Department of Labor, NCERC, and several other Illinois-based research organizations and companies that serve the biotechnology sector. The members of the Partnership will lead in leveraging Illinois existing assets and building incentives to attract new companies to the state to perform research and establish manufacturing facilities.

The passing of Illinois Senate Bill 1693 is a significant step in the right direction for providing the support and incentives companies need to bring their biotechnology businesses to the state of Illinois, said NCERC Executive John Caupert. Now, centers like NCERC will be part of a network with a singular mission to attract more economic growth for our state. This activity will bring in more tax dollars, jobs, and other critical components to establish a burgeoning industry in Illinois.

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NCERC serves companies in the private sector through contractual research services and has helped to commercialize more than 80 technologies that are now in the commercial marketplace, contributing to tens of thousands of jobs and more than $7 billion of annual revenue. By attracting clients from across the globe to perform research at its facility in SIUEs University Park, it also draws hundreds of thousands of dollars in revenue for the nearby hospitality industry. In addition to economic benefits, NCERCs research in biotechnology also supports a variety of workforce training programs by providing hands-on learning opportunities to college students and recent graduates. Since 2014, hundreds of employees who have passed through NCERC on their career paths have found gainful employment in the private sector.

To learn more about NCERC, visit EthanolResearch.com.

About NCERC

The NCERC at SIUE is a nationally recognized research center dedicated to the development and commercialization of biotechnologies. Their unique research laboratories house bench- to demonstration-scale bioreactors and pretreatment and downstream processing equipment, making it the perfect partner to companies in the biotechnology industry. Through their contractual research services, NCERC has played an instrumental role in commercializing more than eighty products that are now used in the commercial marketplace. In addition to its research and development services, NCERC leverages its experienced staff and unique facility to provide a variety of workforce training and education initiatives to train the next generation of bioeconomy professionals. For more information, contact Jackie Hayes at jhayes@ethanolresearch.com, or visit http://www.EthanolResearch.com.

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NCERC Celebrates the Passing of the Illinois Industrial Biotechnology Partnership Act - RiverBender.com

The new report on Animal Health Biotechnology Market Report 2022 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2030 offered by Market Research, Inc. includes a comprehensive analysis of the market size, geographical landscape along with the revenue estimation of the industry. In addition, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Animal Health Biotechnology Market.

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Animal Health Biotechnology Market 2022- Analysis and In-Depth Research on Market Size, Trends, Emerging Growth Factors and Forecast To 2030 - Digital...

Digital Genome Engineering Market Size and Share is Estimated to Growth by US$ 60.35 at CAGR 11.1% during Forecast period 2028

This press release was orginally distributed by SBWire

Londan, United kingdom (SBWIRE) 06/06/2022 Digital Genome Engineering is a comprehensive digital set of genetic material that occurs in a cell or an organism. It allows experts to get a nearer look at genetic disorders, with instant access to sequence data and tools to resolve unending custom queries. Thus, the aforementioned parameters will augment the market growth. Digital Genome Engineering deals with genes & their functions and assists in finding causes behind chronic disorders and also to resolve them. This technology has sparked a revolt in invention-centred research & systems biology to expedite insight of the most complex genetic systems.

The global Digital Genome Engineering market research report provides an in-depth analysis of the existing and future state of the industry. The study comprises all market data and is based on extensive primary and secondary research. Statistics by type, industry, channel, and other parameters are included in the analysis, as well as market volume and value for each category. The coronavirus pandemic has an influence on the global economy. Several market conditions have shifted. The market is fast evolving, according to the study report, and its influence is being studied both now and in the future.

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The study offers exact figures for the industry's market size, share, production capacity, demand, and growth for the anticipated year. This is the most recent market effect analysis research for COVID-19. The Digital Genome Engineering market research looks at the market's top businesses, distributors, and the entire structure of the industrial chain. It also evaluates the aspects and criteria that may have an impact on market expansion.

The Major Key Company Profiles included in Digital Genome Engineering market study are:

-Abbott Laboratories-Agilent Technologies Inc-Becton, Dickinson and Company-Biomerieux SA-Bio-rad Laboratories Inc-Roche-Illumina Inc-Inscripta-Oxford Nanopore Technologies Ltd-Pacific Bioscience-Perkinelmer Inc-Qiagen NV-Regeneron Pharmaceuticals-Thermo Fisher Scientific Inc

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The research looks on the industry's growth goals, cost awareness, and manufacturing procedures. Market segmentation by product type, application, end-user, and geography is discussed in the Digital Genome Engineering research report. A basic industry overview, as well as categorization, definition, and, as a result, the supply and demand chain structure, are included in the market study. Global research includes global marketing data, competitive climate surveys, growth rates, and critical development status information.

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Segmentation by type:

-Miss Target Assessment-Target Efficiency Prediction-Typing Efficiency Prediction-Measurement of Editing Efficiency of Target Genome-Other

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-Hospital-Research Institute-Institutions of Higher Learning

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1 Scope of the Report2 Executive Summary3 Digital Genome Engineering Market Size by Player4 Digital Genome Engineering by Regions5 Americas6 APAC7 Europe8 Middle East & Africa9 Market Drivers, Challenges and Trends10 Global Digital Genome Engineering Market Forecast11 Key Players Analysis12 Research Findings and Conclusion

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Digital Genome Engineering Market Size and Industry Analysis 2022 : Biotechnology Revolution to Boom the Digital Genome Business with Latest Research...