Daily Archives: August 6, 2022

SHANGHAI, Aug. 6, 2022 /PRNewswire/ -- Epigenic Therapeutics Co., Ltd., a frontier biotechnology company dedicated to developing next generation gene editing therapy utilizing regulation of epigenetic genome for wide variety of diseases, today announced it has secured $20 million in Series Angel and Pre-A funding. Series Pre-A funding is jointly invested by Morningside Venture Capital, Kingray Capital, Trinity Innovation Fundand TigerYeah Capital. Angel investor FountainBridge Capital is also participating.

Proceeds of financing will be used to validate advances of the Company's proprietary epigenetic editing in non-human primates, expand expertise and capabilities, and sponsor early-stage clinical investigations.

Epigenetic modification is a natural andheritable gene regulation mechanism in the human body without altering the underlying DNA sequence. Leveraging company's proprietary and patented technology platform, scientists are able to harness endogenous epigenetic gene regulation pathway to precisely and efficiently deliver medicine to target cells and tissues, and achieve potent and durable therapeutic impact. Epigenic Therapeutics has gathered highly talented scientists and industry veterans to direct discovery and development.

"Epigenetic editing is an emerging and highly differentiated gene editing technology." Said Bob Zhang, co-founder and CEO of Epigenic Therapeutics, "along with our scientific co-founders and advisers, we are able to expand our understanding of precise regulation of epigenetic genome, and unlock its potential as medicine for many diseases. With the funding, we will continue expanding our team and capabilities, validate the technology platform in animal model, and accelerate our leading product from discovery to clinical development."

"Epigenic Therapeutics is uniquely positioned in various gene editing therapy developers. We are thrilled to invest in Epigenic Therapeutics and we believe this company has solid foundation to further explore and develop precise genome medicine to benefit many patients." Commented by Michael Xue, Managing Director of Morningside Venture Capital.

About Epigenic Therapeutics' Technology PlatformEpigenic Therapeutics' proprietary technology platform employs its own artificial intelligence (AI) algorithms to explore and obtain an optimized CRISPR-Cascomponent to regulate target gene(s) or govern the expression of one or multiple gene(s) at once without changing the sequence of the DNA. Among peer technologies,our platform is capable to overcome the potential risk rising from DNA cleavage including but not limited to off-target effect, short half-life and challengingpatientcompliance issues. Combing a patented lipid nanoparticle (LNP) medicine delivery system, Epigenic Therapeutics'platform has been proven to precisely and efficiently deliver medicine to target cells and tissuesex vivoandin vivoin ocular, neurodegeneration, metabolic, and rare disease models.

About Epigenic TherapeuticsEpigenic Therapeutics is a frontier biotechnology company dedicated to developing next generation gene editing therapy utilizing regulation of epigenetic genome for a variety of diseases. Founded in 2021 by leading scientists focused on discovering gene editing technologies and developing gene editing therapies, the company has multiple product candidates in the pipeline, including treatment for ocular, neurodegeneration, metabolic, and rare diseases. For more information, visit http://www.epigenictx.com

About Morningside Venture CapitalMorningside Ventures was founded in 1986 by the Chan Family of Hong Kong. Since its establishment, Morningside has been focusing on trends of the forefront life science and healthcare industries over the world, spreading its business scope and investment footprint over North America, Europe and Greater China. Morningside comprises a group of investment professionals who are entrepreneurial, have deep industry knowledge and profound experience in venture capital management. For more information, please visit http://www.morningside.com

About Kingray CapitalKingray Capital was founded in 2018, focusing on investment opportunities in the fields of information security, new energy, industrial intelligence, medical and health care and enterprise services. Kingray Capital is committed to helping high-tech enterprises grow rapidly and creating long-term and stable investment returns for investors.

About Trinity Innovation FundTrinity Innovation Fund ("TIF") is dedicated to investing on biomedical innovations. Our limited partners (LPs) include renowned biopharmaceutical companies and investment institutions. Embedded in our name, TRINITY represents the basic philosophy as "Triad of scientists, managers and investors, let professionals do their own jobs". As investor, TIF helps scientists to transform research outcomes, managers to develop corporates. Together, we turn Innovation into Cure. Leveraging on our profound industry knowledge and resources, we are committed to accelerating growth of our portfolio companies via strategy optimization, recruitment of key positions, partnering and more.

About TigerYeah CapitalTigerYeah Capital, an independent venture capital institution under Tigermed, was founded in 2014.TigerYeah Capital focuses on equity investment in the early and growing medical and health field. The management team has deep industrial background, extensive industrial resources and rich investment experience. Since its inception, TigerYeah Capital whose investment portfolio covers medical devices, biomedicine, CRO and health food has completed nearly 100 projects with the investment of 1.5 billion yuan. Through empowering the invested enterprises, TigerYeah Capital values the development of China and the global medical and health industry and makes contribution to public health.

About FountainBridge CapitalFountainbridge Capital is an avant-garde and emerging venture capital focusing on early-stage innovations. Starting even from ideas or concepts, Fountainbridge works closely with entrepreneurs and researchers to set up new companies and translate innovation into market products. Under the guidance of deep research, Fountainbridge has made outstanding investments in cutting-edge technology including semiconductor, cloud computing, bio-tech and green energy, and consumer innovation like new retailing, overseas brand and novel consumer-electronics. Being the first investor of most portfolios, Fountainbridge is the founder and also the co-founder of start-ups. With a robust ecosystem built, Fountainbridge helps in growth strategy, top industrial experts'recruitment, patent application, legal counseling, and continuous fundraising. Many of Fountainbridge portfolios has become market leaders.

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Epigenic Therapeutics Raises $20 Million in Series Angel and Pre-A Funding to Advance Next Generation Gene Editing Therapy - PR Newswire

The Food and Drug Administration has halted testing of a preclinical cancer medicine from Beam Therapeutics, the biotechnology company announced Monday.

Beam, a high-profile developer of a gene editing technique known as base editing, said in a short statement that the FDA put its request to start human trials of the experimental treatment on clinical hold.

Beam didnt say why the FDA paused its application. The biotech was informed of the agencys decision via an email on Friday, and expects to provide an update pending discussion with the FDA. The regulator will provide Beam with a formal letter within 30 days.

Company shares fell by more than 10% in pre-market trading Monday.

Beam is the leading developer of base editing, an approach borne out of research from the labs of Harvard University gene editing specialist David Liu. Unlike the first generation of CRISPR editing, which cuts both strands of DNA, base editing is designed to change single DNA letters without causing a double-stranded break, a method thats thought to carry fewer risks.

Beam was formed five years ago to turn the approach into human medicines and has since received significant financial support. The company raised $180 million in an initial public offering in February 2020 and in January got $300 million upfront from Pfizer in a wide-ranging research deal. The biotech had $1.2 billion in cash on its balance sheet at the end of the first quarter.

The company has already been cleared by U.S. regulators to start a study of BEAM-101, a drug for sickle cell disease, and expects to start enrolling patients in that trial later this year. Verve Therapeutics also recently began clinical testing of a heart disease drug that uses Beams base editing technology.

BEAM-201, an experimental treatment for leukemia and lymphoma, was expected to follow this year along with a second sickle cell drug called BEAM-102.

Verves treatment is an infusion of a drug that performs base editing inside the body. Beams two most advanced programs, including the cancer drug now on hold, genetically modify cells outside the body.

BEAM-201 is meant to overcome some of the limitations of personalized cancer cell therapies from Bristol Myers Squibb, Novartis and Gilead, which are approved to treat certain leukemias and lymphomas. The treatment uses cells from donors, rather than patients themselves, and silences multiple genes simultaneously an approach Beam claims could make those cells more durable. Several developers of so-called off-the-shelf cell therapies have struggled to prove their drugs are as long-lasting as personalized treatments, however.

The drug is the latest gene-based medicine, meanwhile, to be slowed by regulators. The FDA has recently paused testing of a number of gene replacement or gene editing therapies, wary of potential safety concerns.

This is obviously negative for the stock and reiterates a high level of scrutiny from the regulators on novel technologies like gene/base editing, wrote RBC Capital Markets analyst Luca Issi in a research note. However, we also note that the [application] was submitted at the end of June, so we assume no patient has been dosed, and it is possible that the hold is simply procedural in nature.

Beam is seeking to treat patients with either relapsed or refractory T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma.

Read more from the original source:
FDA halts testing of Beam's base editing cancer therapy - BioPharma Dive

OHSU researchers will receive a grant to helpadvance a first-of-its-kind method to turn an individuals skin cell into an egg, with the potential to produce viable embryos. (OHSU/Christine Torres Hicks)

Scientists at Oregon Health & Science University have received significant philanthropic support to advance a first-of-its-kind method to turn an individuals skin cell into an egg, with the potential to produce viable embryos.

The technique, initially demonstrated in mice, could eventually provide a new avenue for child-bearing among couples unable to produce viable eggs of their own.

Paula Amato, M.D., professor of obstetrics and gynecology in the OHSU School of Medicine, andShoukhrat Mitalipov, Ph.D., director of the OHSU Center for Embryonic Cell and Gene Therapy. (OHSU/Christine Torres Hicks)

Even though the proof of concept in mice shows promise, significant challenges remain to be resolved before the technique could be ready for clinical trials under strict ethical and scientific oversight. Even then, Congress currently precludes the Food and Drug Administration from providing oversight for clinical trials involving genetic modification of human embryos.

Shoukhrat Mitalipov, Ph.D., (OHSU)

It will take probably a decade before we can say were ready, said Shoukhrat Mitalipov, Ph.D., director of the OHSU Center for Embryonic Cell and Gene Therapy. The science behind it is complex, but we think were on the right path.

This type of research is not funded by the National Institutes of Health, so it depends on philanthropic support. For this project, Open Philanthropy awarded $4 million over three years through the OHSU Foundation.

Paula Amato, M.D. (OHSU)

Paula Amato, M.D., professor of obstetrics and gynecology in the OHSU School of Medicine, sees the potential for an enormous benefit to families struggling to have children if the technique proves successful.

Age-related decline in fertility remains an intractable problem in our field, especially as women are delaying childbearing, said Amato, who is the principal investigator for the grant award.

The technique holds promise for helping families to have genetically related children, a cohort that includes women unable to produce viable eggs because of age or other causes, including previous treatment for cancer. It also raises the possibility of men in same-sex relationships having children genetically related to both partners.

The skin cell can come from somebody who doesnt have any eggs themselves, Amato said. The biggest implication is for female, age-related infertility. It can also come from women with premature ovarian insufficiency due to cancer treatment or genetic conditions, or from men who would be able to produce a genetically related child with a male partner.

The award from Open Philanthropy will enable OHSU researchers to develop the technique in early human embryos using eggs and sperm from research donors. As with other groundbreaking research at OHSU including a gene-editing discovery that generated worldwide attention in 2017 none of the early embryos will be allowed to develop past the early blastocyst stage.

Researchers will build on a study in mice published this January in the journal Communications Biology.

The study demonstrated that it is possible to produce normal eggs by transplanting skin-cell nuclei into donor eggs from which the nuclei have been removed. Known as somatic cell nuclear transfer, the technique was famously used in 1997 to clone a sheep in Scotland named Dolly. In contrast to a direct clone of one parent, the mouse study published earlier this year required OHSU and collaborating scientists to cut the donor DNA in half and then fertilize the resulting egg with sperm to generate a viable embryo with chromosomes from both parents.

The process involves implanting the skin cell nuclei into a donor egg, and then allowing the egg to discard half its skin cell chromosomes a process similar to meiosis, when cells divide to produce sperm or egg cells. This results in a haploid egg with a single set of chromosomes with precisely half the chromosomes of the diploid skin cell with two sets of chromosomes. At just the right phase of the cell cycle, the new egg is combined with sperm chromosomes through in vitro fertilization.

An embryo then develops with the correct diploid number of chromosomes from each parent.

We had to show in the mouse that this hypothesis works, Mitalipov said. Open Philanthropy saw the implications for fertility with a new way of looking into this. The key is inducing haploidy.

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OHSU advancing first-of-its-kind strategy to overcome infertility - OHSU News

Wilmington, Delaware, United States, Transparency Market Research Inc.: Gene therapy is one of the best treatment options for most chronic diseases. It involves inserting a functional copy of a gene into a defective cell. Gene therapy is useful in the treatment of cancers, inherited disorders, cardiovascular diseases, and infectious pathogen neurological disorders.

Read Report Overview https://www.transparencymarketresearch.com/viral-vectors-manufacturing-market.html

Viral or non-viral vector methods are used in efficient transfer of therapeutic gene into the target cells. Viral vectors used in gene therapy include adenovirus, lentivirus, retrovirus, and adeno-associated viral (AAV). Non-viral vectors generally depend on delivery of plasmid DNA.

Development of quality vectors in terms of formulation, physical size, cost, and delivery function is quite challenging. To minimize this problem, manufacturers use various approaches such as development of cell line culture, current good manufacturing practices, cell culture system, and expression systems that are used in the development of vectors. This is projected to boost the growth of the global viral vectors manufacturing market.

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Additionally, increase in the number of gene therapy candidates due to rapid development of diseases and rise in funding for gene therapies are expected to fuel the growth of the global viral vectors manufacturing market. The Alliance for Cancer Gene Therapy (ACGT) is a public charity foundation in the U.S. which funds for advancement in cancer gene therapies from laboratory to clinical trials. However, high cost of gene therapies and possible mutagenesis restrain the market.

The global viral vectors manufacturing market can be segmented based on type, disease, application, and region. In terms of type, the global market can be divided into adenoviral vectors, retroviral vectors, adeno-associated viral vectors, and others. The retroviral vectors segment dominated the global viral vectors manufacturing market due to ease of application in major target diseases such as cancer and genetic disorders. Based on disease, the global viral vectors manufacturing market can be classified into cancers, infectious diseases, genetic disorders, and other diseases.

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The genetic disorders segment is anticipated to dominate the market due to increase in research activities on various genetic disorders such as sickle cell anemia, hemophilia A and B, and Huntingtons disease, and a strong gene therapy pipeline in the last phase of drug development. In terms of application, the global market can be bifurcated into gene therapy and vaccinology. The gene therapy segment is expected to account for the largest share of the market due to increase in the number of gene therapy clinical trials conducted for chronic diseases such as cancer, cardiovascular diseases, and neurodegenerative diseases globally.

Geographically, the global viral vectors manufacturing market can be segmented into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. Each region can be divide into specific countries/sub-regions such as the U.S., Canada, the U.K., Germany, Brazil, China, India, and GCC Countries. North America dominated the global viral vectors manufacturing market because of increase in research activities, large number of regenerative medicine companies, rise in prevalence of target diseases, and availability of funds. Asia Pacific is expected to be the most attractive market during the forecast period due to increase in health awareness and demand for advanced medical technology.

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Key players operating in the global viral vectors manufacturing market are Lonza, Merck, Oxford BioMedica, CGT Catapult, Cobra Biologics, uniQure, FUJIFILM Diosynth Biotechnologies, Kaneka Eurogentec, and Spark Therapeutics, among others. These players adopt various strategies such as collaborations, agreements, partnerships, and launch of new products to gain competitive advantage in the market.

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Viral Vectors Manufacturing Market: Increase in the Number of Gene Therapy Candidates due to Rapid Development of Diseases to Drive the Market -...

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SAN FRANCISCO--(BUSINESS WIRE)--1health.io Inc. (1health), an industry-leading healthcare tech company that empowers laboratories to make diagnostic testing accessible and affordable at scale, announces the launch of its Next Generation Diagnostic Platform.

With 1healths innovative platform, laboratories can expand market reach in the clinical and direct-to-consumer segments, and launch tests to healthcare providers, clinicians, and consumers faster, all while offering improved accuracy and an intuitive user interface.

Building on its years of healthcare experience and processing nearly four million diagnostic tests since 2021, 1health has created its next gen platform to enable labs to track insurance, obtain physician authorization, facilitate test ordering and shipping, report on test results quickly, and more. Test ordering is automated in such a way that any testing process - no matter how simple or complex - can be configured into a repeatable, easy-to-use approach. The platforms accuracy and speed enable doctors to focus more on individualized patient care and provide better outcomes for population health. In addition, the platform enables labs to outsource services needed in a product testing workflow to partner organizations. Labs can also stand up a direct-to-consumer store in days using 1health.

1healths Next Generation Diagnostic Platform is modern, cloud-based, secure and compliant, and easy-to-use for all types of testing. It drives affordable, accurate, and timely healthcare outcomes which in turn lead to higher patient satisfaction and better lives lived.

We are entering an exciting age of precision medicine powered by next generation testing and diagnostic services. 1healths mission is to help our lab partners make testing easy to access, affordable, and simple to order, states Mehdi Maghsoodnia, Chief Executive Officer of 1health.

With our direct-to-consumer capabilities, labs can enlist a 3PL to handle shipping and logistics, send orders automatically to specific physicians for review and approval, and, if desired, allow businesses to re-package tests with their own product brand, states Nikhil Arun, VP of Product at 1health. The flexibility, speed, and market reach that 1health offers labs is unprecedented, adds Arun.

No question that 1health is revolutionizing the lab testing experience for patients and healthcare providers, states customer Blaine Smith, COO at Apollo Health Group. In addition, the ability to get a lab up and running in 30 days is an incredibly fast timeline for this kind of deployment, adds Smith.

1healths Next Generation Diagnostic Platform saves precious time, reduces chronic process errors, improves testing visibility, and provides global reach of critical lab tests that may not be available locally. The end result is stronger, more-trusted relationships between laboratories and their customers, better healthcare outcomes for consumers, and ultimately more lives saved.

About 1health.io

1health is driving healthcare innovation by revolutionizing the way laboratories service medical providers and consumers. By providing a modern, secure, and easy-to-use software platform, 1health enables lab testing results to be accurately delivered in minutes, not days or weeks, thereby reducing costs and expanding growth opportunities for laboratories. The result is stronger, more-trusted relationships between laboratories and their customers, better healthcare outcomes for consumers, and ultimately more lives saved.

1health is proud to help leading-edge laboratories like St. Jude Labs, Thomas Scientific, Lucira Health, Gene by Gene, Apollo Health Group, Premier Lab Solutions, and many others and provides testing services to hundreds of leading enterprise companies including Raleys, Starbucks, General Motors Cruise, and the U.S. Air Force. Learn more at: 1health.io.

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Revolutionizing Healthcare Testing: 1health Unveils Next Generation Diagnostic Platform that Enables Precision Medicine at Scale - Business Wire

CAMBRIDGE, Mass., Aug. 4, 2022 /PRNewswire/ --Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, today announced financial results for the second quarter ended June 30, 2022, and highlighted recent Company progress.

"This has been an exciting second quarter for Omega, in which we were thrilled to receive FDA clearance of our first IND application for OTX-2002, representing the first ever Omega Epigenomic ControllerTM, a new class of programmable mRNA therapeutics. This is a critical milestone for Omega as we enter our next phase of growth and reflects our pioneering work to realizethe potential ofepigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Additionally, we were also pleased to share exciting, new supportive preclinical data, both from our lead program OTX-2002 in hepatocellular carcinoma, as well as from another program in our pipeline focused on non-small cell lung cancer, a potential future indication. We look forward to continuing this momentum as we enter the clinic in the second half of this year and further exploring the broad ranging capabilities of our novel platform in additional therapeutic areas."

Recent Business Highlights

Development Pipeline and Platform

Corporate

Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $173.7 million.

Research and development (R&D) expenses for the second quarter of 2022 were $19.4 million, compared to $11.2 million for the second quarter of 2021. The $8.2 million increase in R&D expense was primarily driven by an increase in personnel-related expenses, external manufacturing costs, and study costs in support of the advancement of our programs

General and administrative (G&A) expenses for the second quarter of 2022 were $6.2 million, compared to $3.6 million for the second quarter of 2021. The $2.6 million increase in G&A expense was primarily driven by an increase in personnel-related expenses to support business growth.

Net loss for the second quarter of 2022 was $25.9 million, compared to $15.4 million for the second quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company's growth and operations as a public company.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, are designed to target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visitomegatherapeutics.com, or follow us onTwitterandLinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of our Phase 1/2 MYCHELANGELOTM clinical trial; the potential of the OMEGA platform to engineer programmable epigenetic mRNA therapeutics that successfully regulate gene expression by targeting insulated genomic domains; expectations surrounding the potential of our product candidates, including our lead OEC candidate OTX-2002; and expectations regarding our pipeline, including trial design, initiation of preclinical studies and advancement of multiple preclinical development programs in oncology, immunology, regenerative medicine, and select monogenic diseases. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; potential delays in and unforeseen costs arising from our clinical trials; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason Braco, Ph.D.LifeSci Communications646.751.4361[emailprotected]

Omega Therapeutics, Inc.

Condensed consolidated statements of operations and comprehensive loss

(thousands, except share and per share amounts)

Three Months Ended June30,

Six Months Ended June30,

2022

2021

2022

2021

Collaboration revenue from related party

$

476

$

$

743

$

Operating expenses:

Research and development

19,387

11,184

33,659

20,933

General and administrative

6,202

3,637

11,336

6,452

Related party expense, net

741

384

1,562

763

Total operating expenses

26,330

15,205

46,557

28,148

Loss from operations

(25,854)

(15,205)

(45,814)

(28,148)

Other expense, net:

Interest expense, net

(55)

(190)

(210)

(402)

Change in fair value of warrant liability

(11)

(340)

Other expense, net

(3)

(4)

(52)

(8)

Total other expense, net

(58)

(205)

(262)

(750)

Net loss

$

(25,912)

$

(15,410)

$

(46,076)

$

(28,898)

Net loss per common stock attributable to common

stockholders, basic and diluted

$

(0.54)

$

(3.36)

$

(0.96)

$

Read more from the original source:
Omega Therapeutics Reports Second Quarter 2022 Financial Results and Highlights Recent Company Progress - PR Newswire

image:Collaboration between the Global Alliance for Genomics and Health (GA4GH) and the Standards Council of Canada resulted in GA4GH Phenopackets being published as an ISO standard. view more

Credit: GA4GH / Stephanie Li

The International Organization for Standardization (ISO) has published Phenopackets, the first clear computational way to responsibly share individual patient traits, removing a major barrier to research on disease diagnosis, treatment, and mechanism discovery.

The standard was initially developed by the Global Alliance for Genomics and Health (GA4GH) and championed at ISOunder the Canadian Mirror Committee to ISO/TC215/SC1Genomics informatics, and supported by the Standards Council of Canada.

We finally have the very first standard for phenotype data available worldwide, said University of Colorado professor Melissa Haendel, a GA4GH contributor who launched the Phenopacket idea eight years ago.

Having this ISO standard will encourage software developers, infrastructure developers, healthcare systems to consider Phenopackets as a method for sharing patient-level information securely and in a deidentified way that can be useful for everything from rare to infectious diseases, and addressing many kinds of public health questions, Haendel said.

The standard, ISO 4454 Genomics informatics Phenopackets: A format for phenotypic data exchange, was published on 6 July 2022.

Phenopackets debuted at ISO thanks to theleadership of GA4GH and through the support of Canadas National Member Body, theStandards Council of Canada (SCC), and itsInnovation Initiative.

Beyond furthering the UN Sustainable Development goals for good health and innovation, Phenopackets has the potential to benefit a range of Canadian and global organisations, from Google to the Canadian Institute of Health Research to the Red Cross.

A Phenopacket is a packet of data typically a file that humans and computers can read. It describes a personsphenotype, a term for the way our genes manifest in our bodies, such as hair colour, hormone levels, or a bad reaction to a drug.

For more than a millennium, physicians have used the same technology for recording and sharing phenotypes: the written note.

While handwritten scrawl has morphed into sophisticated electronic health records, fundamentally, little has changed. Clinicians may record two patients identical phenotypes in vastly different ways that are difficult to compare.

For bioinformaticians studying how genes affect our chances of cancer, rare disease, and illness, this freewheeling flexibility is a problem.

If somebody gives you a piece of paper with a bunch of scribbled stuff and says, Do research with that, youre going to go, Well I dont know what that is! You have to read it, understand it, extract all the data, and make sense of it in your head. And that takes time, said Julius Jacobsen, a bioinformatics software developer at Queen Mary University of London who co-leads the GA4GH team working on Phenopackets.

But the Phenopacket provides a sense of how all the bits fit together, like a blank form. All someone has to do is fill in the pre-existing fields, and then they can give you a nice piece of structured information which anyone can understand, said Jacobsen.

So in 2019, GA4GH the worlds standards organisation for genomics approved thePhenopacket standardfor storing phenotypic data in predictable formats that computers everywhere can read.

A few months later, the newly-formed ISO Genomics Informatics subcommittee met in the South Korean city of Daegu. The group chose Phenopackets as one of its very first standards to develop, working in tandem with GA4GH contributors updating the original version of the standard. (Phenopackets v2was adopted forthe ISO standard after being approved in February.)

To officially propose Phenopackets to ISO, GA4GH Work Stream manager Lindsay Smith, who is based at the Ontario Institute for Cancer Research in Toronto, collaborated with the Canadian Mirror Committee to ISO/TC215/SC1, with the support of SCC.

Through programs like its Innovation Initiative, SCC helps innovators to commercialise technologies and facilitates their participation on national and international standardisation committees for the benefit of economic growth and the health and safety of Canadians.

Finding ways to advance health technologies has been an important area of interest for the Innovation Initiative, said Chantal Guay, CEO of SCC. Developing an ISO standard is key to aligning perspectives internationally and promoting shared health information across the world.

Many rounds of reviews from ISO experts in Japan, India, Canada, the U.S., and Korea ensured that Phenopackets would work in diverse healthcare systems.

In Japan, a network of 14 major biobanks has implemented Phenopackets, with 920,000 samples and 250,000 genomic and omics data provided by 490,000 individuals,said Soichi Ogishima, a member of the ISO project team that reviewed Phenopackets.

Researchers can access phenotypic information with GA4GHs Phenopackets standard for capturing clinical data and integrating them with genomic data to develop precision medicine,added Ogishima, a professor of genomic informatics at Tohoku University in Sendai, Japan.

The humble Phenopacket has the potential to transform the treatment of common disease.

Asthma, inflammatory bowel disease, schizophrenia, and other complex conditions are unlikely to be one disease. But its been difficult to divide these diseases into groups that respond to specific treatments. One reason is because everybody uses their own formats, so you cannot combine data, said Peter Robinson, a computational biologist at the Jackson Laboratory who co-leads the GA4GH Phenopackets development team.

By using Phenopackets, well be able to improve precision medicine for individuals by being able to compare and cluster patients based upon their individual characteristics, he said.

The standard could also improvestudy and diagnosis of rare disease.

There should be a tool for patients to share their information as Phenopackets, said Haendel. Right now, there are rare disease patients all over social media sharing free text that could be structured in such a way that we could mine it as data for example, to identify patients who have the same condition around the world.

Patient matchmaking would get easier with a database of cases described in the Phenopacket format.

Many journals in human genetics are willing to consider cajoling or requiring authors to submit Phenopackets together with case reports. Usually if you find a new disease gene, youll describe ten patients, but none of that information is accessible at the patient level, said Robinson.

In June, Robinson, Jacobsen, Haendel, Smith, and collaborators published anarticle inNature Biotechnologyoutlining how Phenopackets lets researchers and cliniciansexchange patient characteristics more effectively and link those data to genomic information.

While the Phenopacket schema is stillavailable free of costfrom GA4GH, ISO publication significantly broadens its reach. Beyond Japanese biobanks, databases like the widely-used BioSamples have already implemented Phenopackets. Electronic health record vendors and national health systems are considering the standard.

As an added benefit, any organisation that adopts Phenopackets can easily link to other powerful clinical and research tools from the GA4GHGenomic Data Toolkit.

Going forward, there are plans to build Phenopackets into standards for sharing electronic health records, such as Fast Healthcare Interoperability Resources (FHIR) by the Health Level 7 (HL7) organisation.

Phenopackets was chosen as one of HL7sVulcan Accelerator projects. Accelerator projects try to improve how clinical studies are designed, conducted and reported by advancing the implementation of research-ready standards. A project to represent Phenopackets in the FHIR standard is underway to make sure that this schema thats now an ISO standard can also be used in the context of HL7, said Haendel.

Phenopackets may be the first GA4GH standard published by ISO, but it will not be the last. Currently, the ISO Genomics Informatics subcommittee is reviewing a proposed standard for genomic surveillance systems such as the public health systems that track Covid-19 variants spreading around the world. GA4GH standards feature prominently within the requirements.

When standards development organisations align their work, everyone benefits.

The ISO publication of Phenopackets exemplifies the benefits of standards coordination. When different standards-setting bodies collaborate, it amplifies the impact of all our standards. Truly global standards expand responsible data sharing and bring the benefits of precision medicine to more patients and their families, said Peter Goodhand, Chief Executive Officer of GA4GH.

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About the Global Alliance for Genomics and Health (GA4GH)

The Global Alliance for Genomics and Health (GA4GH) is an international, nonprofit alliance formed in 2013 to accelerate the potential of research and medicine to advance human health. Bringing together 600+ leading organisations working in healthcare, research, patient advocacy, life science, and information technology, the GA4GH community is working together to create frameworks and standards to enable the responsible, voluntary, and secure sharing of genomic and health-related data.

About the Standards Council of Canada (SCC)

Since 1970, the Standards Council of Canada (SCC) has helped make life safer, healthier, more prosperous and sustainable for people, communities and businesses in Canada through the power of standardization. SCC works with a vast network of partners nationally and around the world, acting as Canadas voice on standards and accreditation on the international stage, including as a member of the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC). As the countrys leading accreditation organization, SCC creates market confidence at home and abroad by ensuring conformity assessment bodies meet the highest expectations. In all these ways, SCC opens a world of possibilities. For more information, visithttps://www.scc-ccn.ca(link is external)

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Reshaping how doctors and researchers share phenotypic information: first GA4GH standard published by ISO - EurekAlert