GenVivo, Inc.

GEN2’s dose-escalation trial, GVO-1102, will establish the Recommended Phase 2 Dose (RP2D), followed immediately by an expansion phase into 3 solid tumor types. GEN2 has a dual mechanism: 1) initial suicide gene killing, independent of the tumor’s antigens, and 2) the release of patient-specific tumor antigens which in the presence of the payload-encoded cytokine results in the generation and activation of immune effector cells. Each cycle of GEN2 maintains and continually amplifies therapeutic immune cytolytic responses as more tumor cells are killed and release antigen (including mutating neoantigens). GEN2 is an off-the-shelf, non-replicating immunotherapy vector administered by intravenous infusion; it enables immediate treatment without the time delays and expense associated with tumor biopsies and genomic sequencing. PASADENA, Calif., June 27, 2024 (GLOBE NEWSWIRE) -- GenVivo, Inc., a private, clinical-stage biopharmaceutical company with breakthrough off-the-shelf platforms for cancer gene medicine immunotherapies, announced that it has dosed the first US patient in a Phase I/Ib, open-label, dose-escalation and expansion clinical trial of GEN2. GEN2, GenVivo’s first product candidate to enter clinical development, is a non-replicating mRNA gene therapy vector being developed as a cancer immunotherapy to both kill tumors and activate a patient’s immune system against their individual cancer antigens (neoantigens). GEN2 is an off-the-shelf medicine, providing the advantages of a personalizing therapy without the time delays and expense associated with autologous products or tumor genome sequencing. This GEN2 Phase I/Ib, dose-escalation clinical trial (NCT06391918) is currently enrolling US patients with advanced solid tumors who have progressed or were non-responsive to prior therapies. The clinical trial is primarily designed to assess the safety and tolerability of GEN2 and to establish the recommended Phase II dose (RP2D). Following the initial dose-escalation phase, the expansion phase will explore the RP2D in 3 arms with defined solid tumor types, to further demonstrate safety, tolerability, and signs of clinical activity. Pharmacokinetic and exploratory biomarker endpoints will be assessed. Additional data relevant to efficacy will be obtained from paired-tumor biopsies, measuring payload expression, immune cell infiltration and activation, and tumor killing. “The initiation of this US trial represents an important milestone in our efforts to systemically administer our off-the-shelf personalizing gene medicine platform to activate a cancer patient’s immune system against the full breadth of their unique tumor antigens,” said Robert G. Johnson, M.D., Ph.D., Chief Operating Officer of GenVivo, Inc. “We are encouraged by the potential of GEN2 (demonstrated in a prior phase 1 trial, NCT04313868) and look forward to advancing to the expansion phase once the appropriate dose is identified.” Daneng Li, M.D., Associate Professor, Department of Medical Oncology & Therapeutics Research, Hepatobiliary Lead and Co-Director, Neuroendocrine Tumor Program, City of Hope, Duarte, CA added “We are excited to be working with the GenVivo team on GEN2, an innovative dual-payload targeted vector, with the goal to improve therapies for our patients with refractory disease.” About GEN2 GenVivo’s product candidate, GEN2, is designed to kill the tumor and trigger direct tumor release of patient specific neoantigens in the presence of a locally produced cytokine. The vector mRNA payload encodes an optimized prodrug-activated enzyme (enhanced viral thymidine kinase (HSV-eTK)) and an immunostimulatory cytokine (GM-CSF). The orally administered prodrug, modified by the HSV-eTK, directly kills tumor cells, releasing the patient’s full complement of unique tumor antigens in the presence of the immunostimulatory cytokine, to then directly stimulate tumor-specific killer cells. These tumor-lytic immune cells amplify and maintain ongoing tumor cell killing, including subsequently arising tumor mutations (neoantigens) and tumors at metastatic sites. Data from 59 patients in a Phase 1 trial in Asia, demonstrated safety and tolerability with signs of clinical benefit (NCT04313868). GVO-1102 (NCT06391918) will complete the intravenous dose escalation started in the Phase 1 trial in Asia. About GenVivo GenVivo is a private, vertically-integrated biotechnology company with cGMP manufacturing capabilities, founded to develop the latest novel gene delivery and immune stimulation therapies, which activate the patient’s immune system to treat cancers and prevent infectious diseases. GenVivo is committed to developing and manufacturing products that are rapidly deployed, and easily administered, with the goal of increasing patient survival and improving quality of life. For more information about GenVivo, visit Forward-Looking Statements This press release contains forward-looking statements of GenVivo, Inc. (“GenVivo”) that involve substantial risks and uncertainties. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current beliefs and expectations and are not guarantees of future performance. GenVivo may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. In addition, the forward-looking statements included in this press release represent GenVivo’s views as of the date of this press release. GenVivo anticipates that subsequent events and developments will cause its views to change. However, while GenVivo may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. “GenVivo,” the GenVivo logo and other trademarks, trade names or service marks of GenVivo appearing in this press release are the property of GenVivo. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of such products or companies. Contact Victor Constantinescu, M.Eng Head of Business Development BD@genvivoinc.com 626-768-5162

DUBLIN, June 20, 2022 /PRNewswire/ -- The "Gene Therapy Global Market Report 2022: By Gene, By Vector, By Application, By End-User" report has been added to ResearchAndMarkets.com's offering. The global gene therapy market is expected to grow from $5.77 billion in 2021 to $7.37 billion in 2022 at a compound annual growth rate (CAGR) of 27.8%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $21.25 billion in 2026 at a CAGR of 30.3% The gene therapy market consists of sales of gene therapy related services by entities (organizations, sole traders and partnerships) that manufacture gene therapy drugs. Gene therapy is used to replace faulty genes or add new genes to cure disease or improve the body's ability to fight disease. Only goods and services traded between entities or sold to end consumers are included. The main types of gene therapy are antigen, cytokine, suicide gene and others. Antigen is a poison or other foreign substance that triggers an immunological response in the body, including antibody formation. The different vectors include viral vector, non-viral vector, others and is used in oncological disorders, rare diseases, cardiovascular diseases, neurological disorders, infectious diseases, others. it is implemented in various sectors such as hospitals, homecare, specialty clinics, others. Incidences of cancer and other target diseases have been increasing significantly, which is calling for effective treatments, driving the growth of the gene therapy market. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the gene therapy market during the forecast period. According to the American Cancer Society, there were 1.7 million new cases and 0.6 million cancer deaths in 2019 in the USA. The four most common types of cancer worldwide are lung, prostate, bowel, and female breast cancer, accounting for 43% of all the new cancer cases. Therefore, the rise in the cancer incidence rate globally is anticipated to boost the demand for the gene therapy market over the forthcoming years. Gene therapy is one of the most effective treatments in oncology. In this treatment, new genes are introduced into a cancerous cell or the surrounding tissue to cause cell death or slow the growth of cancer. For instance, in September 2019, RMIT University, Australia has found that non-viral gene therapy can be used to speed up cancer research, which can bring patient-friendly cancer treatment in the market. The high prices of gene therapy medicines are expected to limit the growth of the gene therapy market. The pressure to contain costs and demonstrate value is widespread. Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding. In less wealthy countries, the lack of cost-effective therapies for cancer and other diseases has influenced the health conditions of the population and has led to a low average life expectancy. Luxturna, a one-time treatment for acquired retinal eye disease, costs $850,000 in the US and £613,410 in the UK, despite a markdown that is applied through Britain's National Health Service. Zolgensma, for spinal muscular atrophy, is valued at $2.1 million in the US and Zynteglo, which focuses on a rare genetic blood disorder, costs $1.78 million, thus restraining the growth of the market. The use of machine learning and artificial intelligence is gradually gaining popularity in the gene therapy market. Artificial intelligence (AI) is the simulation of human intelligence in machines, which are programmed to display their natural intelligence. Machine learning is a part of AI. Machine learning and AI help companies in the gene therapy market to conduct a detailed analysis of all relevant data, provide insights between tumor and immune cell interactions, and offer a more accurate evaluation of tissue samples often conflicted between different evaluators. It is also expected to reduce turnaround time and also the cost of gene therapies. Major players in the gene therapy market are Novartis AG Bluebird Bio, inc. Spark Therapeutics, inc. Audentes Therapeutics Voyager Therapeutics Applied Genetic Technologies Corporation UniQure N.V. Celgene Corporation Cellectis S.A. Sangamo Therapeutics Gilead Lifesciences, inc. Orchard Therapeutics Sibiono GeneTech Co., Ltd. Gensight Biologics S.A. Shanghai Sunway Biotech Co., Ltd. Biogen Sarepta Therapeutics, inc. Sangamo Therapeutics Audentes Therapeutics Regenxbio, inc. Gegenxbio, inc. Oxford BioMedica plc. Dimension Therapeutics, inc. Bristol-Myers Suibb Company Sanofi Taxus Cardium Pharmaceuticals Group, inc. (Gene Biotherapeutics) Shrine plc. Benitech Biopharma Transgene Epeius Biotechnologies Corp. Calimmune, inc. Key Topics Covered: 1. Executive Summary 2. Gene Therapy Market Characteristics 3. Gene Therapy Market Trends And Strategies 4. Impact Of COVID-19 On Gene Therapy 5. Gene Therapy Market Size And Growth 5.1. Global Gene Therapy Historic Market, 2016-2021, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Gene Therapy Forecast Market, 2021-2026F, 2031F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market 6. Gene Therapy Market Segmentation 6.1. Global Gene Therapy Market, Segmentation By Gene Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Antigen Cytokine Suicide Gene Others 6.2. Global Gene Therapy Market, Segmentation By Vector, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Viral Vector Non-Viral Vector Others 6.3. Global Gene Therapy Market, Segmentation By Application, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Oncological Disorders Rare Diseases Cardiovascular Diseases Neurological Disorders Infectious Diseases Others 6.4. Global Gene Therapy Market, Segmentation By End Users, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Hospitals Homecare Specialty Clinics 7. Gene Therapy Market Regional And Country Analysis 7.1. Global Gene Therapy Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion 7.2. Global Gene Therapy Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets