Texas-based GMP Plasmid CDMO VGXI, Inc. and Geneos Therapeutics, Inc. Expand their Clinical Manufacturing Supply Agreement in Support of Geneos’ Ongoing GT-30 Phase Ib/IIa Clinical Trial for advanced hepatocellular carcinoma (HCC).
The Woodlands, TX – VGXI, Inc., an industry leading manufacturer for pre-clinical through cGMP clinical plasmid DNA, announced that its partner Geneos Therapeutics, Inc. has executed a new purchasing contract under their current Clinical Manufacturing Supply Agreement to support the expansion of the ongoing GT-30 clinical trial. The Geneos trial is focused on treatment of patients with advanced hepatocellular carcinoma, an aggressive form of liver cancer, using Geneos’ proprietary neoantigen-targeting personalized immunotherapy platform, GT-EPIC™.
VGXI, Inc. has developed an accelerated manufacturing process for Geneos’ GT-30 clinical program capable of providing clinical grade plasmid DNA in a fraction of the standard industry turnaround times without compromising product quality. In successfully supporting the initial phase of the GT-30 trial, VGXI has demonstrated rapid turnaround times associated with this process and its suitability for personalized therapy applications.
Mr. Young Park, VGXI’s President and CEO stated, “VGXI appreciates the opportunity to continue our collaboration and partnership with Geneos Therapeutics. The renewed agreement is a testament to the experience and capabilities of the VGXI team in meeting the challenging requirements of this project, and we look forward to supporting the expansion of the ongoing clinical trial.”
“Geneos is delighted to expand our relationship with VGXI as we continue to treat patients with their own exquisitely personalized immunotherapies on the GT-30 study,” said Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics. “The innovative VGXI team has enabled and supported one of Geneos’ key differentiators of an accelerated turnaround time from biopsy to administration of personalized treatments to patients with our GT-EPIC™ based therapies.”
ABOUT VGXI, INC. VGXI, Inc. has nearly 20 years of experience and is a leading provider of plasmid DNA manufacturing and development services. 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 GeneOne company.
ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. (“GeneOne” KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II).
VGXI, Inc., a GeneOne company located in The Woodlands, Texas, is the global leading CDMO for cGMP DNA plasmid manufacture.
For more information, visit http://www.genels.com.
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 and personalized treatments for cancer. We have an experienced management team with a track record of success in building immunotherapy-based companies. For more information, visit https://www.geneostx.com.
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.
Media Contacts: Christy Franco, PhD Sr. Manager, Business Development Email