Industry recognized plasmid DNA manufacturer VGXI, Inc. to support production of personalized cancer therapies as part of a long-term supply agreement with Geneos Therapeutics.
June 22, 2019, The Woodlands, TX and Plymouth Meeting, PA – Plasmid CMO VGXI, Inc. and Geneos Therapeutics, Inc., a spin-out of Inovio Pharmaceuticals (NASDAQ: INO) focused on developing DNA-based, Neoantigen-targeting personalized cancer immunotherapies, announced today they have entered into a long-term master supply agreement. The agreement will leverage VGXI’s highly experienced management team and decades of plasmid manufacturing proficiency to establish small-scale and rapid turnaround production services ideally suited for the personalized therapy approach. VGXI’s proprietary plasmid manufacturing process is recognized for providing the highest purity and supercoil fraction for DNA-based pharmaceuticals, in particular DNA vaccines. To meet urgent patient needs, this process will be optimized to enable turnaround times 1/10 of that for standard GMP grade products without compromising product quality. Completion of all process development, qualification, and validation activities at VGXI is projected by end of 2019, with clinical grade production of patient-specific DNA-plasmid based products for human clinical use by 1Q 2020.
According to VGXI CEO Young K. Park, “VGXI is excited to support the Geneos platform and enable the next generation of personalized cancer therapies. I have no doubt our technology and experienced team will ensure success for their product pipeline.”
Geneos Therapeutics is developing neoantigen-targeting, personalized cancer immunotherapies based on its clinically validated Exquisitely Personalized Immunotherapies for Cancer (GT-EPIC) Platform. Dr. Niranjan Y. Sardesai, Geneos’ CEO, said “The GT-EPIC platform has demonstrated in preclinical models and clinical studies the safety of the platform and its ability to drive cancer antigen specific immune responses. A key challenge for treating advanced cancers is the tumor biopsy-to-treatment turnaround time for patient specific treatments which are only manufactured after the patient signs up for the treatment. Geneos is pleased to partner with the experienced team at VGXI to realize one of its key competitive advantages of rapid manufacturing for each patient.”
VGXI, Inc. has over 15 years of experience and is a leading provider of manufacturing and development services for DNA vaccines and gene therapies. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc.
ABOUT GENEOS THERAPEUTICS’ GT-EPIC NEOANTIGEN-TARGETING PLATFORM
Geneos Therapeutics’ GT-EPIC Neoantigen-Targeting Platform is based on a clinically-validated DNA vaccine platform exclusively licensed from Inovio Pharmaceuticals, Inc. (NASDAQ: INO) for use in developing personalized, neoantigen-targeting immunotherapies. The platform has been used extensively and safely by Inovio Pharmaceuticals in the clinical treatment of patients with over 2,000 patients treated and over 6,000 administrations. The GT-EPIC platform allows Geneos to develop exquisitely personalized DNA-based therapies tailored to each patient’s unique tumor mutations. The GT-EPIC platform is poised to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos believes that these are the three key differentiators that will drive the company, and the oncology space, into the next generation of immunotherapies.
ABOUT GENEOS THERAPEUTICS
At Geneos Therapeutics, we believe that personalized therapies are the future of cancer treatment. Our passion is to develop personalized therapies to unleash the most powerful force against cancer – your body’s own immune system. Our approach using our GT-EPIC platform is to target unique neoantigens (abnormal mutations produced by cancer cells) from individual patient tumors to develop novel treatments for cancer.We have an experienced management team with a track record of success in building immunotherapy-based companies. Geneos was created as a spinout of Inovio Pharmaceuticals, Inc. (NASDAQ: INO). For more information, visit http://www.geneostx.com
ABOUT GENEONE LIFE SCIENCE
GeneOne Life Science Inc. (“GeneOne” KOSPI: 011000) is an international DNA vaccine and product developer and leading contract manufacturer of DNA plasmid-based agents for pre-clinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines and products to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world. For more information, visit http://www.genels.com/en
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.
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Christy Franco, PhD