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Application of ImmTOR plus Sareptas investigational gene therapies will be evaluated for Duchenne Muscular Dystrophy and Limb-Girdle Muscular Dystrophies

CAMBRIDGE, Mass. and WATERTOWN, Mass., June 18, 2020 (GLOBE NEWSWIRE) --Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, and Selecta Biosciences, Inc. (NASDAQ: SELB) today announced that they have entered into a Research License and Option agreement granting Sarepta an option to license the rights to develop and commercialize Selectas immune tolerance platform, ImmTOR, for use in Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). In advance of exercising its option, Sarepta will conduct research and evaluate the utility of ImmTOR to minimize or prevent the formation of neutralizing antibodies (NAb) to adeno-associated virus (AAV) in connection with the administration of Sareptas DMD and LGMD gene therapy candidates.

Sareptas late-stage gene therapy candidates are delivered using AAV in particular, AAVrh74. AAVrh74 was selected because of its safety profile, superior muscle tropism, empirical demonstration of high expression, and low screen-out rate for pre-existing antibodies. Currently, however, all systemic AAV-delivered constructs are one-time therapies that cannot be re-dosed due to the robust post-administration development of NAbs specific to the AAV vector. Selecta is a leader in immune tolerance and has generated strong preclinical evidence to support the potential for re-dosing patients receiving gene therapy.Selecta has reported that in preclinical studies, when used in combination with AAV gene therapy vectors,Selectas ImmTOR immune tolerance platform inhibits the development of NAbs to the vector, permitting re-dosing of the gene therapy. i

As we build our enduring gene therapy engine, we intend not only to rapidly advance treatments for rare, life-ending diseases, but at the same time, to advance the state of genetic medicine science by continually improving the utility of gene therapy. If successful, the ability to re-dose will be an enormous leap forward in the science of gene therapy and provide invaluable benefits to patients beyond those we anticipate with one-time dosing. We are encouraged by the data generated on the ImmTOR platform and excited to join with Selecta to explore the possibility of unlocking the opportunity to safely and effectively re-dose AAV-mediated gene therapies in patients with DMD and LGMDs, if needed, said Doug Ingram, President and Chief Executive Officer, Sarepta Therapeutics.

We are pleased to build on our already strong foundation of strategic partnerships and expand the clinical application of the ImmTOR platform into neuromuscular diseases. The ability to re-dose gene therapy addresses one of the major challenges of one-time therapies today, said Carsten Brunn Ph.D., President and Chief Executive Officer of Selecta Biosciences. We are excited to collaborate with a leader in genetic medicine like Sarepta, and are confident that their expertise in rare diseases combined with our immune tolerance platform has the potential to enhance the long-term therapeutic benefit to patients with these debilitating conditions.

DMD is a rare, degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. LGMDs are a group of over 30 distinct diseases that cause weakness and wasting of the muscles around the hips and shoulders, eventually progressing to the arms and legs. LGMD can be caused by a single gene defect that affects specific proteins within the muscle cell, including those responsible for keeping the muscle membrane intact.

Under the terms of the research license and option agreement, Sarepta will make an initial payment to Selecta, and Selecta is eligible to receive certain pre-clinical milestone fees. If Sarepta exercises its options to enter any commercial license agreements, Selecta will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales. Additional financial details are not being disclosed.

About Selecta Biosciences, Inc.

Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its pioneering immune tolerance platform (ImmTOR). Selecta is committed to utilizing ImmTOR to potentially improve the efficacy of biologics, enable re-dosing of life-saving gene therapy, and create novel immunotherapies for autoimmune diseases. Selectas late-stage product candidate, SEL-212, is designed to be a monthly treatment for chronic refractory gout, a debilitating rare disease with a significant unmet medical need. SEL-212 consists of a combination of our ImmTOR platform co-administered with pegadricase, an enzyme designed to treat patients with symptomatic gout, refractory to standard uric acid lowering treatment. Selectas proprietary gene therapy product candidates are in development for certain rare inborn errors of metabolism and incorporate our ImmTOR platform with the goal of addressing barriers to repeat administration. In addition to our own pipeline of core discovery and clinical candidates, Selecta has established collaborative relationships with leading biopharmaceutical companies, including Asklepios BioPharmaceutical (AskBio) for gene therapy, and Swedish Orphan Biovitrum AB (Sobi) for SEL-212. Selecta is based in Watertown, Massachusetts. For more information, please visit http://www.selectabio.com.

Selecta Forward-Looking Statements:

SelectaBiosciences, Inc. (the company), including without limitation, the companys actions regarding the monitoring and assessment of COVID-19 on the companys operations, clinical trials and manufacturing, Sareptas plans to evaluate its gene therapies in combination with the companys ImmTOR technology, the possibility of Sarepta exercising an option to enter into a commercial license agreement, the unique proprietary technology platform of the company and the unique proprietary platform of its partners, the potential of ImmTOR to enable re-dosing of AAV gene therapy, the ability of the companys ImmTOR platform to unlock the full potential of biologic therapies, the potential treatment applications for product candidates utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the novelty of treatment paradigms that Sarepta is able to develop in combination with the companys ImmTOR technology, the potential of any therapies developed by Sarepta in combination with the companys ImmTOR technology to fulfill unmet medical needs, the companys plan to apply its ImmTOR technology platform to a range of biologics for rare and serious diseases, the ability of Sareptas existing therapies to target the heart and skeletal muscle, expected payments to be made to the company under the Research License and Option Agreement, the potential of the ImmTOR technology platform generally and the companys ability to grow its strategic partnerships, the sufficiency of the companys cash, cash equivalents and short-term investments, and other statements containing the words anticipate, believe, continue, could, estimate, expect, hypothesize, intend, may, plan, potential, predict, project, should, target, would, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the effect of the COVID-19 outbreak on any of the companys planned or ongoing clinical trials, manufacturing activities, supply chain and operations, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the companys ImmTOR technology, Sareptas ability to research and develop therapeutic candidates using the companys ImmTOR technology, undesirable side effects of the companys product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials as well as the impact of the COVID-19 outbreak on those third parties and their ability to continue their operations, the companys inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, managements ability to perform as expected, potential delays in regulatory approvals, Sareptas ability to make up-front and milestone payments, the companys business development strategy, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the companys recurring losses from operations and negative cash flows from operations raise substantial doubt regarding its ability to continue as a going concern, substantial fluctuation in the price of its common stock including stock market fluctuations that occur as a result of the COVID-19 outbreak, and other important factors discussed in the Risk Factors section of the companys most recent Quarterly Report on Form 10-Q, and in other filings that the company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the companys views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any intention to update any forward-looking statements included in this press release.

AboutSarepta Therapeutics

At Sarepta, we are leading a revolution in precision genetic medicine and every day is an opportunity to change the lives of people living with rare disease. The Company has built an impressive position in Duchenne muscular dystrophy (DMD) and in gene therapies for limb-girdle muscular dystrophies (LGMDs), mucopolysaccharidosis type IIIA, Charcot-Marie-Tooth (CMT), and other CNS-related disorders, with more than 40 programs in various stages of development. The Companys programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visitwww.sarepta.comor follow us onTwitter,LinkedIn,InstagramandFacebook.

Sarepta Forward-Looking Statement

This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the parties undertakings under the agreement and potential payments and fees; the potential benefits of Sareptas gene therapy product candidates; the potential of ImmTOR to enable re-dosing of AAV gene therapy; Sareptas intention to rapidly advance treatments for rare, life-ending diseases, and to advance the state of the genetic medicine science by continually improving the utility of gene therapy; the potential of re-dosing to provide invaluable benefits to patients beyond those Sarepta anticipates with one-time dosing;the possibility of unlocking the opportunity to safely and effectively re-dose AAV-mediated gene therapies in patients with DMD and LGMDs, if needed; and the potential of the collaboration between Sarepta and Selecta to enhance the long-term therapeutic benefit to patients with these debilitating conditions.

These forward-looking statements involve risks and uncertainties, many of which are beyond our control. Known risk factors include, among others: the expected benefits and opportunities related to the collaboration between Sarepta and Selecta may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development. In particular, the collaboration may not result in any viable treatments suitable for commercialization due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement; success in preclinical trials does not ensure that later clinical trials will be successful; Sarepta may not be able to execute on its business plans and goals, including meeting its expected or planned regulatory milestones and timelines, clinical development plans, and bringing its product candidates to market, due to a variety of reasons, many of which may be outside of Sareptas control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover Sareptas product candidates and the COVID-19 pandemic; and even if Sareptas programs result in new commercialized products, Sarepta may not achieve the expected revenues from the sale of such products; and those risks identified under the heading Risk Factors in Sareptas most recent Annual Report on Form 10-K for the year ended December 31, 2019, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect Sareptas business, results of operations and the trading price of Sareptas common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Selecta Contacts:For Media:Joshua R. MansbachSolebury Trout+1-646-378-2964jmansbach@soleburytrout.com

For Investors:Lee M. SternSolebury Trout+1-646-378-2922lstern@soleburytrout.com

Sarepta Contacts: Investors:Ian Estepan, 617-274-4052iestepan@sarepta.com

Media:Tracy Sorrentino, 617-301-8566tsorrentino@sarepta.com

_____________________________iNature Communications,October 2018.

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Sarepta Therapeutics and Selecta Biosciences Enter into Research License and Option Agreement for Selecta's ImmTOR Immune Tolerance Platform in...

A research team led by Francesca Luca, Ph.D., associate professor of Wayne State Universitys Center for Molecular Medicine and Genetics, has published a study that annotated environmental components that can increase or decrease disease risk through changes in gene expression in 43 genes that could exacerbate or buffer the genetic risk for cardiovascular disease. Their results highlight the importance of evaluating genetic risk in the context of gene-environment interactions to improve precision medicine.

Interpreting Coronary Artery Disease Risk Through GeneEnvironment Interactions in Gene Regulation was published in Genetics, the journal of the Genetics Society of America.

The study, said Dr. Luca, also of the WSU Department of Obstetrics and Gynecology, illustrates that combining genome-wide molecular data with large-scale population-based studies is a powerful approach to investigate how genes and the environment interact to influence risk of cardiovascular disease.

By identifying regions of DNA important for endothelial cell response to different common environmental exposures, the researchers discovered that caffeine can influence the risk of cardiovascular disease. The study demonstrates the potentially beneficial and/or detrimental effects of certain environmental exposures on the cardiovascular disease risk differ depending on individual DNA sequence.

The study focused on cardiovascular disease, Dr. Luca said, because it is the leading cause of death, both in the United States and worldwide. Also, the disease is highly multifactorial, with large contributions from both environmental and genetic risk factors. By treating endothelial cells under a controlled environment, we can discover how these genetic and environmental risk factors influence each other at the molecular level, she said. Our lab has developed expertise in cardiovascular research, with additional projects using endothelial cells to develop new assays to test the regulatory activity of genetic variants. The approach outlined in this paper can be applied to many different diseases; for example, our lab has also focused on how bacteria in the human gut affect gene expression in the colon, and also on the effect of psychosocial stress on asthma.

While the work identified regions of the genome important for how endothelial cells respond to the environment and can influence the risk of cardiovascular disease, the researchers do not yet know exactly which genetic variants are directly responsible. A former graduate student, Cynthia Kalita, developed an assay to test thousands of genetic variants for gene regulatory activity. The researchers can test the variants discovered in their study using that assay to validate and explore the mechanisms by which they exert their effects, Dr. Luca said. They also are developing computational/statistical methods that can yield better personalized risk scores.

We have extended our approach to study cardiomyocytes, which are the muscle cells of the heart. Healthy heart tissue is difficult to obtain, so we have collaborated with researchers at the University of Chicago to derive cardiomyocytes from stem cells, Dr. Luca said. This will allow us to shift our focus from the vasculature to the heart itself, where we can study diseases like cardiomyopathies and arrhythmias.

As the cost of DNA sequencing continues to decrease, Dr. Luca expects that genetic testing will play a greater role in preventive health care. To fully realize the potential of precision medicine, we need to consider both genetic and environmental risk factors of disease, and how they interact. While there are already direct-to-consumer tests that prescribe an individualized diet based on DNA, these products currently offer no demonstrated clinical value. However, with very large numbers of individuals for whom we have both DNA sequencing and information on diet and lifestyle, we may one day be able to offer better recommendations.

Others involved in the study included Anthony Findley, an M.D./Ph.D. student; Allison Richards, Ph.D., a research scientist; Cristiano Petrini, of the Center for Molecular Medicine and Genetics; Adnan Alazizi, lab manager; Elizabeth Doman, of the Center for Molecular Medicine and Genetics; Alexander Shanku, Ph.D., research scientist; Gordon Davis, of the Center for Molecular Medicine and Genetics; Nancy Hauff, Department of Obstetrics and Gynecology; Yoram Sorokin, M.D., professor of Obstetrics and Gynecology; Xiaoquan Wen, of the Department of Biostatistics at the University of Michigan; and Roger Pique-Regi, Ph.D., associate professor of the Center for Molecular Medicine and Genetics, and of the Department of Obstetrics and Gynecology.

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Researchers identify environmental components that affect gene expression in cardiovascular disease - The South End

Posted 18 June 2020 | By Michael Mezher

Officials from the US Food and Drug Administration (FDA) discussed the agencys recent efforts to support the development of products to treat rare diseases during a session at DIAs Global Annual Meeting on Wednesday.Orphan and rare pediatric disease designationsWhile the number of products approved to treat rare diseases has increased over the last decade, the vast majority of rare diseases lack approved treatment options.Janet Maynard, director of FDAs Office of Orphan Products Development, gave an update on FDAs orphan drug designation program. According to Maynard, orphan drug designation requests have stabilized at just over 500 requests per year since 2016. The number of designations granted have also remained stable, in the mid-300s since 2015, with a spike to 477 in 2017.Maynard also discussed FDAs rare pediatric disease designation and priority review voucher program, which is set to sunset later this year without legislative action.Between 2013 and 2016 we saw a steady increase in terms of the number of rare pediatric disease designations requests we have received, and that number has remained greater than 50 since 2016, she said. FDA has granted more than 50 rare pediatric disease designations each year since 2017.However, Maynard pointed out that, After 30 September 2020, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug and that designation was granted by 30 September 2020, and that the agency will no longer issue vouchers regardless of designation after 30 September 2022.Companies looking to get in under the wire will need to submit requests for rare pediatric disease designation soon, Maynard said. FDA guarantees a 60-day review for rare pediatric disease designation requests issued alongside a fast track or orphan designation request but does not commit to a specific timeline for requests submitted separately.The Offices of Orphan Product Development and Pediatric Therapeutics cannot commit to providing a response to rare pediatric disease designation requests by 30 September 2020 for any requests received after 31 July 2020, Maynard said.OND reorganization and rare disease hubAfter undergoing a major reorganization earlier this year, FDAs Office of New Drugs (OND) is better equipped to address rare disease drug development, said Hylton Joffe, acting director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine.Joffes office oversees three clinical divisions, the Division of Pediatrics and Maternal Health, the Division of Rare Diseases and Medical Genetics and the Division of Urology, Obstetrics and Gynecology.You can imagine, given the significant burden of rare diseases in children, how having these three divisions together could lead to very strong collaborations in the rare disease space, Joffe said.Joffe pointed out that the newly created Division of Rare Diseases and Medical Genetics, which oversees the rare disease group and inborn errors review group, is the only division within OND that is solely focused on rare diseases. While other offices within OND also deal with rare diseases, We see this new division and this office as the new OND rare disease hub, Joffe said, adding that the goal of the hub will be to enhance communication and consistency for rare diseases.Gene therapiesFollowing the approval of the first few gene therapies, Elizabeth Hart, branch chief at the Office of Tissues and Advanced Therapies within the Center of Biologics Evaluation and Research, said expectations are high for future gene therapies to treat rare diseases.Hart said that the number of gene therapies in development has increased significantly in recent years, with investigational new drug applications (INDs) for gene therapies increasing more than 140% between 2016 and 2019. According to Hart, 70% of gene therapy INDs are targeting rare diseases.While the approval standard for gene therapies and other rare diseases is the same as for other drugs, Hart said that the clinical development plans for those products could look very different from those for more common conditions.We do have the option to exert regulatory flexibility, and this is especially important for rare diseases. Clinical development programs for the different diseases may vary substantially, and so they really need to be individualized, she said.Hart also said that, There are no specific minimum number of patients to be studied to establish effectiveness and safety of a gene therapy, the number of subjects needed is determined on a case by case basis taking into consideration the persuasiveness of the data, including comprehensiveness and quality; the nature of the benefit provided; the length of the treatment exposure, the patient population that would be treated after marketing approval; and concerns for potential harm from the treatment.

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FDA officials update on orphan drugs, gene therapies at DIA - Regulatory Focus

ST. LOUIS, June 18, 2020 /PRNewswire/ -- OpenCell Technologies, an R&D-stage biomedical venture, has announced the hiring of Kevin Gutshall as CEO. Kevin leaves his role as MilliporeSigma's director of life science business development and M&A focusing on the cell and gene therapy business unit, to join OpenCell and lead its efforts to translate and commercialize its core technology platform, POROS.

OpenCell was established based on technology developed at the Georgia Institute of Technology, by Engineering faculty and company co-founders Mark Meacham, PhD, Andrei Fedorov, PhD, and Levent Degertekin, PhD. Dr. Meacham was subsequently recruited to Washington University in St. Louis, and OpenCell relocated to the BioGenerator Labs in the Cortex Innovation Community adjacent to the Washington University School of Medicine. The company's core technology, which has broad applications ranging from fuel and energy to life sciences, is focused on the rapidly emerging cell and gene therapy market.

"I am thrilled to join OpenCell, as it is now poised to move from an R&D stage to a commercial business," said Gutshall. "I believe that the POROS platform will be a disruptive technology platform in the cell and gene therapy marketplace."

During its seed stage, the company benefitted from BioGenerator Entrepreneurs-in-Residence (EIR) that brought key expertise to the company as it pivoted from the research tools market to cell and gene therapy applications. Paul Olivo, MD, PhD, a former BioGenerator EIR and current Venture Partner at Synchrony Bio, which also participated in the current financing, serves as a key advisor to OpenCell, managing the company's research team. In her role as BioGenerator EIR, Heather Holeman, PhD, now CEO of Lifespan Biosciences, facilitated key business development connections for the company. Concurrent with the financing, Charlie Bolten, Senior Vice President of BioGenerator, joins OpenCell's board of directors.

"Together with Synchrony Bio, BioGenerator's investment in OpenCell is the culmination of extensive due diligence and hands-on support by our investment, Entrepreneur-in-Residence and Grants-2-Business teams," said Bolten. "With the successful recruitment of a CEO with deep experience in commercialization, business development and M&A, we are pleased to see OpenCell take an important step toward commercializing the POROS platform."

"I am excited to welcome Kevin as the new CEO of OpenCell," added Chad Stiening, OpenCell Executive Chairman and Managing Director at Synchrony Bio. "His professional background and personal passion in the cell and gene therapy space is a perfect fit for the company as it seeks to realize the full potential of its technology and enable the development and manufacturing of promising new therapies in this dynamic market."

In addition to investments from BioGenerator and Synchrony Bio, the company has leveraged significant Federal grant funding over $3M total to help secure equity financing and achieve key milestones that helped attract strategic partnering interest as well as its new CEO.

About OpenCellOpenCell Technologies provides efficient, high-throughput and scalable transfection tools to the Life Science Industry, enabling it to use difficult-to-transfect cells (e.g., primary and cancer stem cell cultures) in development of cell-based analysis techniques and discovery of new therapeutic cell-based therapies. Unlike currently available products, the OpenCell technology features precise control of biophysical actions on a single-cell basis without sacrificing throughput. OpenCell's vision is to realize a novel, cost-effective approach to transfection that will overcome existing research and development obstacles.Our mission is to make cellular therapies effective, affordable and scalable for the clinical and research communities. Visit opencelltech.com for more information.

About BioGenerator BioGenerator, the investment arm of BioSTL, produces a sustained pipeline of successful bioscience companies and entrepreneurs in St.Louis by creating, growing and investing in promising new enterprises. Visit biogenerator.org for additional information, and follow us on LinkedIn and Twitter.

About Synchrony BioSynchrony Bio seeks to achieve consistently superior investor returns in early-stage biomedical and life science ventures by aligning seasoned talent, staged investment capital, and process efficiencies.Careful and coordinated alignment of all three is key to overcoming unique challenges faced by medical device and diagnostics ventures, in order to realize significant upside and superior returns.Synchrony's extended network of experts and advisors includes professionals with deep, cross-functional experience and backgrounds. Visit synchronybio.com for additional information.

SOURCE BioSTL

http://www.biostl.org

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Cell and gene therapy-focused OpenCell Technologies hires MilliporeSigma executive Kevin Gutshall as new CEO - PRNewswire

]]> Giroctocogene fitelparvovec is being developed as part of an agreement between Sangamo and Pfizer for the global development of gene therapies for hemophilia A. Credit: Coolcaesar.

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Pfizer and Sangamo Therapeutics have reported positive follow-up data from the Phase I/II Alta study of giroctocogene fitelparvovec (PF-07055480) to treat patients with severe hemophilia A.

The investigational gene therapy Giroctocogene fitelparvovec consists of a recombinant adeno-associated virus serotype 6 vector (AAV6) encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII.

The open-label, dose-ranging, multi-centre Alta clinical trial has been designed to assess the safety and tolerability of the therapy in severe hemophilia A patients.

Across four dose cohorts, the mean age of the 11 patients assessed is 30 years and all are male.

All five patients with severe hemophilia A were given the 3e13 vg/kg dose and they showed sustained factor VIII (FVIII) activity levels, with a median of 64.2% via chromogenic assay.

No patients experienced bleeding events or required FVIII infusions during the trial.

Pfizer Rare Disease Research Unit senior vice-president and chief scientific officer Seng Cheng said: We are excited that these data affirm previous findings from this Phase I/II study, and that all five patients have sustained levels of factor VIII activity with no bleeding events or use of factor replacement therapy.

The Phase III lead in study is ongoing, and we look forward to dosing patients with this investigational gene therapy in the pivotal Phase III trial later this year.

Giroctocogene fitelparvovec received orphan drug, fast track, and regenerative medicine advanced therapy (RMAT) designations from the US Food and Drug Administration and Orphan Medicinal Product designation from the European Medicines Agency.

The therapy is being developed as part of a collaboration agreement between Sangamo and Pfizer for the global development and commercialisation of gene therapies for hemophilia A.

Sangamo chief medical officer Bettina Cockroft said: These follow-up data indicate that treatment with giroctocogene fitelparvovec resulted in sustained factor levels up to 14 months following treatment and suggests the potential of this investigational gene therapy to alleviate the treatment burden of current hemophilia disease management.

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Pfizer and Sangamo report positive data from hemophilia A therapy trial - Clinical Trials Arena

UCLA researchers and colleagues have received a $13.65 million grant from the National Institutes of Health to investigate and further develop an immunotherapy known as CAR T, which uses genetically modified stem cells to target and destroy HIV.

The five-year grant, part of an NIH effort to develop gene-engineering technologies to cure HIV/AIDS, will fund a collaboration among UCLA; CSL-Behring, a biotechnology company in the United States and Australia; and the University of WashingtonFred Hutchinson Cancer Research Center.

Scott Kitchen, an associate professor of medicine in the division of hematology and oncology, and Irvin Chen, director of the UCLA AIDS Instituteat the David Geffen School of Medicine at UCLA, are leading the effort. The project will build on their previous research using CAR T therapy to combat the virus, which is constantly mutating and difficult to beat.

The overarching goal of our proposed studies is to identify a newgene therapy strategy to safely and effectively modify a patients own stem cells to resist HIV infection andsimultaneously enhance their ability to recognize and destroy infected cells in the body in hopes of curing HIV infection, said Kitchen, who also directs the humanized mouse core laboratory for UCLAs Center for AIDS Research and Jonsson Comprehensive Cancer Center.It is a huge boost to our efforts at UCLA and elsewhere to find a creative strategy to defeat HIV.

The only known cure of an HIV-infected person was announced in 2008. The famous Berlin patient received a stem cell transplant from a donor whose cells naturally lacked a crucial receptor that HIV binds to in order to kill cells and destroy the immune system. The main problems with this approach, the researchers say, are that the donor and recipient have to be highly matched often a rare event and that it often fails to produce a sufficient amount of HIV-protected cells that can clear the virus from the body.

Transplantation of blood-forming stem cells has been the only treatment strategy that has resulted ina functional cure for HIV infection, Kitchen said. Over 13 years after the first successfully cured HIV-infected patient, there is a substantial need to develop strategies that are capable of being used on everyone with HIV infection.

One of those strategies, CAR T, has been the subject of ongoing research at UCLA by Chen, Kitchen and others. This approach involves genetically engineering a patients own blood-forming stem cells to carry genes for chimeric antigen receptors, or CARs. Once these stem cells are modified and transplanted back into the patient, they form specialized infection-fighting white blood cells known as T cells in this case, CAR T cells that specifically seek out and kill HIV-infected cells. In a recent study, the UCLA scientists found that engineered CAR T cells not only destroyed infected cells but also lived for more than two years the length of the study.

The thinking behind the NIH-funded project, the researchers say, is that a combination of CARs and broadly neutralizing antibodies may be a long-lasting, perhaps permanent, cure for HIV.

Our work under the NIH grant will provide a great deal of insight into ways the immune response can be modified to better fight HIV infection, said Chen, who is a professor of medicine and of microbiology, immunology and molecular genetics at the Geffen School of Medicine. The development of this unique strategy that allows the body to develop multiple ways to attack HIV could have an impact on other diseases as well, including the development of similar approaches targeting other types of chronic viral infections and cancers.

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UCLA receives nearly $14 million from NIH to investigate gene therapy to combat HIV - UCLA Newsroom

Overview: Regenerative medicine is an interdisciplinary field that applies life science and engineering principles for the regeneration or repair of injured/diseased tissues or organs resulting from various causes including, disease, defects, trauma and aging. The field includes the generation and use of tissue engineering, therapeutic stem cells and the production of artificial organs. It also allows scientists to grow organs or tissues in the lab and implant them in the body safely when the body fails to heal itself. Notably, it has great potential to solve the problem of organ shortage.

Request For Report [emailprotected]https://www.trendsmarketresearch.com/report/sample/9918

According to the estimation of World Health Organization, there is an increasing prevalence of diabetes among adults over the age of 18 years, that has increased to 8.5% in 2014 compared to 4.5% in 1980 across the globe. As per the estimation of Arthritis Foundation, the number of people expected to be diagnosed from arthritis will be more than 78 million, by 2040.

The market for regenerative medicine is driven by increasing prevalence of neuronal disease, cancer and genetic disease, emerging application of regenerative medicine, and advancement in technology. Huge number of ongoing clinical trails and strong product pipeline are providing market growth oppurtunity. High cost of the treatment, regulatory issues and ethical issuesare hampering the market growth.

Market Analysis: The Global Regenerative Medicine market is estimated to witness a CAGR of 16.6% during the forecast period 20182024. The global market is analyzed based on three segments Therapy, Application and regions.

Regional Analysis: The regions covered in the report are the North America, Europe, Asia Pacific, and Rest of the World (ROW). North America is the major shareholder in the global regenerative medicine market, followed by Europe. Asia-Pacific region is expected to have the fastest growth rate with the market growth centered at Japan, China and India. This is mainly due to increasing funding in healthcare research, rising research activities, growing patient pool, flexible regulatory environment for clinical trials, and rising healthcare expenditure.

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Therapy Analysis:Immunotherapy occupied major market share of global regenerative medicine market in 2017, and is expected to remain same during the forecasted period. Increasing product approvals, emerging technological advancements in cell and gene therapy, flexible regulatory for stem cell based research, and growing awareness regarding the benefits of stem cell therapies.

Application Analysis: The market by application is segmented into cancer, central nervous system, orthopedic and musculoskeletal, diabetes, dermatology, cardiovascular and others. Among various application, dermatology occupied the largest share in 2017 and cancer segment is expected to grow at fastest rate during the forecasted period. Growing aging population, changing lifestyle, increasing disease prevalence makes cancer, the fastest growing application segment during the forecasted period.

Key Players: Allergan plc, Integra lifesciences, Mimedx Group, Inc., Medtronic plc, Organogenesis Inc., Zimmer Biomet, Acelity L.P. Inc., Nuvasive, Inc., Stryker Corporation, Japan Tissue Engineering Co., Ltd. (Fujifilm Holdings Corporation subsidiary), Osiris Therapeutics, Inc., Vericel Corporationand other predominate and niche players.

Competitive Analysis: Currently dermatology segment dominates the global regenerative medicine segment. A lot of researches are going on cancer, CNS, cardiovascular, orthopedic & musculoskeletal applications. The increasing importance of regenerative medicine has resulted in the launch of new products and also increased acquisition, approvals, funding to develop new product.

For instance, in August 2017, Tissue Regenix Group plc completed the acquisition of acquisition of CellRight Technologies, an US based specialist in regenerative osteoinductive bone scaffolds. In April 2018, Roche acquired a program named Inception 5, focused on regenerative therapies for multiple sclerosis. In May 2018, Novartis received second FDA approval for Kymriah, CAR-T cell therapy for B-cell acute lymphoblastic leukemia (ALL)

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Benefits: The report provides complete details about the usage and adoption rate of regenerative medicine in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

Link:
Regenerative Medicine Market to Record a Robust Growth Rate for the COVID-19 Period - Cole of Duty

Houston has played a significant role in boosting the nations biotech industry. While Houston is still a hotspot for energy and oil, the city is steadily becoming a burgeoning life sciences hub. In fact, the city boasted the third fastest-growing biotech community in the nation between 2014 and 2017, according to a CBRE report. Houstons biotech industry is gaining momentum due to an increase in funding as well. According to the Greater Houston Partnership, nearly $180 million in VC funding was allocated to the citys ecosystem of life sciences-related companies in 2019 alone.

Like many startups and tech companies across Houston, the citys life sciences leaders have been tackling some of the worlds most pressing issues. Whether theyre developing oncology drug candidates or advancing genomic medicine through the creation of sequencing technologies, the citys biotech organizations are pulling on decades of research and determination to transform the medical landscape on a global scale. Heres a look at 15 biotech companies in Houston making a major impact on medical research and discovery.

Founded: 2015

Focus: Canine Cancer Treatment

What they do:CAVU Biotherapiesprovides immune-based solutions to treat cancer and autoimmune diseases in dogs. The company offers an immune health monitoring service, which describes a dogs immune system through the use of a blood sample, as well as an autologous prescription product that retrains and expands a dogs T cells to recognize and fight cancer. CAVU Biotherapies ultimate aim is to use its immune-guided medicine to treat horses, cats, andeventually, humans.

Founded: 2006

Focus: Stem Cell Banking + Therapy

What they do: Founded by David Eller and Dr. Stanley Jones, Celltex Therapeutics focuses on developing stem cell therapies for a variety of conditions. The companys stem cell processing and banking methods are designed to ensure the genetic integrity and uniformity of an individuals cells in quantities necessary for therapeutic applications. Using proprietary technology, Celltex Therapeutics enables stem cells to be used for regenerative therapy for conditions like vascular, autoimmune and degenerative diseases.

Founded: 2006

Focus: Cell Therapy

What they do: InGeneron is a clinical stage cell therapy company that specializes in novel, evidence-based regenerative medicine therapies. The companys therapy is designed to repair injured tissue, improve the quality of life for patients and modify the progression of their disease. InGeneron focuses mainly on musculoskeletal indications such as pain management.

Founded: 2006

Focus: Cancer Treatment

What they do: Moleculin Biotech is a pharmaceutical company dedicated to the treatment of highly resistant cancers and viruses. The company develops oncology drug candidates for highly resistant tumors as well as as prodrug to exploit the potential uses of inhibitors of glycolysis. Guided by the aim to provide new hope to cancer patients, Moleculin Biotech focuses on discovering new treatments for acute myeloid leukemia, skin cancer, pancreatic cancer and brain tumors.

Founded: 2001

Focus: Nanomedicine

What they do: Nanospectra Biosciences is spearheading a patient-centric use of nanomedicine for the removal of cancerous tissues. The companys ultra-focal nanoshell technology is designed to thermally destroy solid tumors without damaging adjacent healthy tissue. Nanospectra Biosciences aims to maximize treatment efficacy while minimizing side effects associated with surgery, radiation and traditional focal therapies.

Founded: 2018

Focus: Cell Therapy

What they do: Marker Therapeutics is an immuno-oncology company that focuses on the development of next-generation T cell-based immunotherapies. With the aim of treating hematological malignancies and solid tumor indications, the company uses its own MultiTAA T cell technology, which is based on the selective expansion of non-engineered, tumor-specific T cells. Marker Therapeutics is also working on developing proprietary DNA expression technology that is intended to improve the cellular immune systems ability to recognize and destroy diseased cells.

Founded: 2008

Focus: 3D Cell Culture

What they do: Nano3D Biosciences is dedicated to the development of 3D cell culture solutions. The companys core technology allows them to levitate or bioprint cells, which results in the formation of cultures that are more easily assembled and handled. Nano3D Biosciences products and services are intended for biomedical research, drug discovery, precision medicine, toxicology and regenerative medicine.

Founded: 2017

Focus: Small Molecule Inhibitors

What they do: Tvardi Therapeutics is a clinical-stage biotech company working on a new class of medicines for cancer, chronic inflammation and fibrosis. The company is focusing on the creation of orally delivered, small molecule inhibitors of STAT3, which is a key regulatory protein positioned at the intersection of many disease pathways. Tvardi Therapeutics is dedicated to delivering safe and effective solutions for use in the treatment of numerous diseases.

Founded: 2011

Focus: Targeted Cancer Therapies

What they do: Salarius Pharmaceuticals focuses on developing targeted therapies to treat various types of cancers. The companys lead candidate, Seclidemstat, is intended to treat Ewing sarcoma, a pediatric and young adult bone cancer that currently lacks targeted therapies. Salarius Pharmaceuticals performs clinical trials for the treatment of other advanced solid tumors including prostate, breast and ovarian cancers.

Founded: 2013

Focus: Genomic Medicine

What they do: Founded by Michael Metzker, RedVault Biosciences develops technologies with the aim of advancing genomic medicine. The company is currently working on a variety of projects including the development of sequencing technologies to determine haplotypes and structural variation in complex genomes. RedVault Biosciences is dedicated to identifying technology needs, creating and testing ideas, and transferring deliverables to production and distribution.

Founded: 2010

Focus: DNA Sequencing

What they do: Avance Biosciences focuses on assay development, assay validation and sample testing using next-generation DNA sequencing and other biological methods. The company offers biologics testing, diagnostic assay validation, GMO genomic testing, gene / cell therapy testing, digital and real-time PCR, microbial testing and more. Avance Biosciences aim is to assist its clients in advancing drug development and genomic research.

Founded: 2008

Focus: Bioremediation

What they do: Bionex Technology develops cost-effective, natural solutions for cleaning oil-polluted soil. The companys Super Microbe spill solution is naturally derived from microbes that digest and convert harmful contaminants on the ground and in soil, therefore lowering flammability, suppressing harmful vapors and creating a safer environment for spill responders. Bionex Technology offers a variety of other bioremediation products such as a customizable degreaser and detergent used for cleaning industrial tools.

Founded: 2016

Focus: Stem Cell Research

What they do: Located in nearby Sugar Land, Hope Biosciences is dedicated to developing stem cell-based therapies that are safe, effective and secure. The companys proprietary technology enables patients to make virtually unlimited and identical stem cells from their own tissue. Hope Biosciences offers stem cell banking solutions for both adults and newborns.

Founded: 2013

Focus: Interventional Cardiology

What they do: Saranas has created technology that enables the early detection and monitoring of bleeding complications associated with vascular access procedures. The companys monitoring system checks changes in the blood vessels electrical resistance before monitoring if bleeding has occurred from an unintentionally injured blood vessel. Saranas aims to allow physicians to mitigate downstream consequences by addressing bleeds before they become complications.

Founded: 1984

Focus: Microbiology

What they do: Microbiology Specialists Inc. specializes in microbiology testing, playing a role in microbial investigations and studies. The company also focuses on infectious disease diagnosis, forensic bacteriology and mycology, medical device testing and infection prevention. Microbiology Specialists Inc. is committed to delivering reliable, accurate and cost-effective microbiological results.

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15 Biotech Companies In Houston To Know - Built In

NEW YORK, June 19, 2020 (GLOBE NEWSWIRE) --Ovid Therapeutics Inc.(NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to OV101 (gaboxadol) for the treatment of Angelman syndrome. OV101 is believed to be the only delta ()-selective GABAA receptor agonist in development and is currently being evaluated in the Companys pivotal Phase 3 NEPTUNE trial in Angelman syndrome, with topline results expected in the fourth quarter of 2020. The FDA has previously granted Orphan Drug and Fast Track designations for OV101 for the treatment of Angelman syndrome.

Under the Creating Hope Act passed into federal law in 2012, the FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. If a new drug application (NDA) for OV101 in Angelman syndrome is approved, Ovid may be eligible to receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be transferred and/or sold to other companies for their programs, such as has recently been done by other voucher recipients.

OV101 has the potential to become the first FDA-approved therapy for individuals living with Angelman syndrome. Receiving Rare Pediatric Disease Designation from the FDA is a significant milestone for this program and underscores the critical value of our work, said Amit Rakhit, M.D., MBA, President and Chief Medical Officer of Ovid Therapeutics. Importantly, with this designation, we may be eligible to receive a priority review voucher from the FDA, providing significant value as we work diligently towards the completion of our ongoing pivotal Phase 3 NEPTUNE trial. We are grateful to the FDA and Congress for having enacted this law which helps Ovid and all companies developing innovative drugs for rare pediatric conditions.

About Angelman SyndromeAngelman syndrome is a rare genetic condition that is characterized by a variety of signs and symptoms. Characteristic features of this condition include delayed development, intellectual disability, severe speech impairment, problems with movement and balance, seizures, sleep disorders and anxiety. The most common cause of Angelman syndrome is the loss of function of the gene that codes for ubiquitin protein ligase E3A (UBE3A), which plays a critical role in nerve cell communication, resulting in impaired tonic inhibition. Individuals with Angelman syndrome typically have normal lifespans but are unable to live independently. Therefore, they require constant support from a network of specialists and caregivers. Angelman syndrome affects approximately 1 in 12,000 to 1 in 20,000 people globally.

There are no approved therapies by the FDA, European Medicines Agency (EMA), or rest of world for Angelman syndrome, and treatment primarily consists of behavioral interventions and pharmacologic management of symptoms.

Angelman syndrome is associated with a reduction in tonic inhibition, a function of the delta ()-selective GABAA receptor that allows a human brain to decipher excitatory and inhibitory neurological signals correctly without being overloaded. If tonic inhibition is reduced, the brain becomes inundated with signals and loses the ability to separate background noise from critical information.

About OV101 (gaboxadol)OV101 is believed to be the only delta ()-selective GABAA receptor agonist in development and the first investigational drug to specifically target the disruption of tonic inhibition, a central physiological process of the brain that is thought to be the underlying cause of certain neurodevelopmental disorders. OV101 has demonstrated in laboratory studies and animal models to selectively activate the -subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and thereby impact neuronal activity through modulation of tonic inhibition.

Ovid is developing OV101 for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and thereby address several core symptoms of these conditions. In both these syndromes, the underlying pathophysiology includes disruption of tonic inhibition modulated through the -subunit of GABAA receptors. In preclinical studies, it was observed that OV101 improved symptoms of Angelman syndrome and Fragile X syndrome. This compound has also previously been tested in more than 4,000 patients (more than 1,000 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles. Ovid is conducting a pivotal Phase 3 clinical trial with OV101 in Angelman syndrome (NEPTUNE) and has completed a Phase 2 signal-finding clinical trial with OV101 in Fragile X syndrome (ROCKET).

OV101 has received Rare Pediatric Disease Designation from the FDA for the treatment of Angelman syndrome. The FDA has also granted Orphan Drug and Fast Track designations for OV101 for both the treatment of Angelman syndrome and Fragile X syndrome. In addition, the European Commission (EC) has granted orphan drug designation to OV101 for the treatment of Angelman syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101. The issued patents expire in 2035 without regulatory extensions.

About Ovid TherapeuticsOvid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The Companys most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharmaceutical Company Limited for the potential treatment of rare developmental and epileptic encephalopathies (DEE). For more information on Ovid, please visit http://www.ovidrx.com/.

Forward-Looking StatementsThis press release includes certain disclosures that contain forward-looking statements, including, without limitation, statements regarding: advancing and commercializing Ovids product candidates, progress, timing, scope and the development and potential benefits of Ovids product candidates; and the anticipated reporting schedule of clinical data regarding Ovids product candidates. You can identify forward-looking statements because they contain words such as will, appears, believes and expects. Forward-looking statements are based on Ovids current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include uncertainties in the development and regulatory approval processes, and the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovids filings with the Securities and Exchange Commission under the caption Risk Factors. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovids business and the global economy. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts

Investors and Media:Ovid Therapeutics Inc.Investor Relations & Public Relationsirpr@ovidrx.com

Or

Investors: Steve KlassBurns McClellan, Inc.sklass@burnsmc.com(212) 213-0006

Media:Katie Engleman1ABkatie@1abmedia.com

Original post:
Ovid Therapeutics Receives FDA Rare Pediatric Disease Designation for OV101 for the Treatment of Angelman Syndrome - BioSpace

Precision Medicine Market Size was valued around USD 50 billion in 2018 and is expected to witness lucrative growth from 2019 to 2025.

Rising demand and advancements in cancer biology will augment personalized medicine market during the forecast timeframe. Development of novel genetic technologies that discovers the functional effect of genetic information that leads in developing cancer, thus, should propel huge demand for cancer biology. However, the high price associated with usage of precision medicine may restrict the precision medicine market growth over forecast period.

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On the basis of technology the precision medicine market is segregated into big data analytics, bioinformatics, gene sequencing, drug discovery, companion diagnostics. Rising focus of competitors on producing advanced drugs leading to better treatment for several chronic diseases will drive drug discovery segmental growth. Similarly, rising incidence of chronic as well as respiratory diseases will drive the growth of the market.

Precision medicine market by application is further divided into oncology, immunology, central nervous system (CNS), respiratory diseases. Increasing prevalence of cancer cases and usage of precision medicine in development of new drugs will increase the oncology segmental market growth. Similarly, increasing demand for bioinformatics and big data analytics to set apart human genome data secured from immunological processes augment segmental growth.

On the basis of end users, the precision medicine market is further divided as pharmaceutical companies, diagnostic companies, healthcare IT companies. Rising demand for producing novel tools for rapid integration, storage, and analysis of patient information will drive the business growth.

North America is anticipated to account for the largest share of the Global Precision Medicine Market. Increasing prevalence of cancer across the U.S will augment the growth of the precision medicine market. Similarly, rising healthcare expenditure will drive the growth of precision medicine market over the forecast period. Asia-Pacific is expected to show rapid growth in coming years owing to growing number of investments in R&D activities.

By Technology

By Application

By End users

By Region

Company Coverage

Conclusion:

In this report, we had discussed the market situation of Precision Medicine Market. As we know the world is going to be tech savvy, the demand of trending products and technologies is also increasing. This report can help to understand the business growth in the Precision Medicine Market and new opportunities at new places.

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Global Precision Medicine Market Growth From 2019 to 2025- Market Report, Insights Analysis And Opportunities - Cole of Duty