OVM-200 Drug Product, manufactured to Good Manufacturing Process (GMP), has been certified stable three years post manufacture – a major milestone for OVM’s lead cancer vaccine, OVM-200
Oxford, UK – 31st January 2024
Press Release – OVM-200 major milestone three year stabilty
Oxford Vacmedix (OVM), the clinical stage company developing therapeutic cancer vaccines, announced today that OVM-200 has been tested and independently certified as stable three years after manufacture. OVM-200 was manufactured for OVM by Eurofins Amatsi, to exacting GMP standards. The GMP drug substance for OVM-200 is dispensed into vials for use in clinical trials and is being used in the ongoing Phase 1 trial of OVM-200. Three year stability is an important milestone in the development of cost efficient cancer vaccines using the novel Recombinant Overlapping Peptide (ROP) technology pioneered by Professor Shisong Jiang.
OVM-200 is an ROP based vaccine that targets survivin, over expressed in many solid tumours. It is being trialled in the UK in five leading hospitals, to treat ovarian cancer, prostate cancer and non-small cell lung cancer. Phase 1a, the first part of a Phase 1 trial, was completed in 2023 and demonstrated both safety and a very strong immune response as well as allowing the selection of the optimal dose regime of OVM-200 for use to treat late stage cancer. Phase 1b is ongoing.
Dr Debra Nevin, CEO and Senior Consultant at Amethyst Pharma commented;
“The Recombinant Overlapping Peptide platform technology is a completely new approach for making vaccines to treat cancer. Manufacturing these complex peptides is not straightforward and new techniques were developed to manufacture the first ROP vaccine, OVM-200, to GMP standard. The robustness of the manufacturing process is demonstrated through the drug product for OVM-200 remaining stable at three years and has been confirmed through independent quality testing”.
William Finch, CEO of Oxford Vacmedix added;
“We are very pleased to have reached this significant milestone for OVM-200. Stable drug product means that existing stock of OVM-200 can continue to be used and that future manufacturing of ROP based vaccines is likely to have at least four year stability. This will contribute towards cost efficient manufacturing and lower cost of goods. We look forward to the completion of Phase 1 and to extending the clinical development of OVM-200 in combination with immune oncology agents.”
ENDS
For more information or to express an interest in investing in Series B please contact:
William Finch, CEO, Oxford Vacmedix
T: +44 (0)1865 742087 | M: +44(0)7769 903711 | E: wfinch@oxfordvacmedix.com
Dr Anthony Coombs, Executive Chairman, Oxford Vacmedix
T: +44 (0)1865 742087 | M: +44(0)7919 002161 | E: acoombs@oxfordvacmedix.com
Notes to Editor
About Oxford Vacmedix
Oxford Vacmedix UK Ltd, based at the Oxford Science Park, UK, is a bio-pharma company that was spun out from the University of Oxford’s Department of Oncology and is utilising the novel proprietary platform technology of recombinant overlapping peptides (ROPs) invented by Professor Shisong Jiang. ROPs have been validated as a technology to stimulate broad and strong T cell immunity therefore forming a good platform for therapeutic vaccines and diagnostics in cancer and infectious diseases.
The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune oncology (IO) agents. The company has extensive contacts and collaborations in China through Changzhou Bioscience Group (CBIG) that is using the ROP platform for diagnostics in both cancer and in infectious diseases.
OVM is developing two lead vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at cervical cancer, and OVM-200 represents a new type of vaccine utilising survivin to target solid tumours including prostate, ovarian and non-small cell lung cancer (NSCLC). Both vaccines will be tested as single agents and in combination with IO agents. OVM has a strong pipeline, with a diagnostic for anti-microbial resistance being tested and two other cancer vaccines is preclinical development.
OVM secured Series A investment from DxVx (formerly Cancer ROP), a leading South Korean biotech company, and from existing shareholders in China in 2018. The company is currently seeking Series B funding to advance OVM-200 to Phase 2 and OVM-100 into Phase 1 trials, as monotherapy and also in combination. In addition, the option of using MRNA delivery with the ROP technology is being developed in Professor Jiangs’s research unit.
For more information: https://www.oxfordvacmedix.com