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MHRA approval for Phase 1 trial of lead cancer vaccine OVM-200
MHRA approval for Phase 1 trial of lead cancer vaccine OVM-200
10 August 2021
Regulatory approval of OVM-200 for Phase 1 signals a significant step for Oxford Vacmedix with the first clinical trial of a cancer vaccine based on the recombinant overlapping peptide platform
Oxford 10th August 2021; Oxford Vacmedix, the UK-based biopharma company focused on the development of cancer vaccines announced today that approval for a Phase 1 trial of OVM-200 has been received from the MHRA (Medicines and Healthcare products Regulatory Authority). Ethics approval for the trial has already been granted. OVM-200 is a cancer vaccine developed using OVM’s novel recombinant overlapping peptide (ROP) platform. It targets survivin, a protein overexpressed by cancer cells, which prevents them being attacked by the body’s immune system.
The Phase 1 trial of OVM-200 will focus on safety and on establishing an immune response in patients with three tumour types – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. It will be run by LabCorp (formerly Covance) at five sites in the UK including University College Hospital (UCH) London, the cancer hospital of the Oxford University Hospitals Foundation Trust (OUHFT) and the Christie in Manchester. The Principal Investigator for the trial is Professor Martin Forster, based at UCH. The trial is both the first time OVM-200 will have been used in people and also the first time an ROP based vaccine has been tested in the clinic.
Dr Tom Morris, Chief Medical Officer of Oxford Vacmedix said;
“We are very pleased to have received both Ethics approval and now also the MHRA regulatory approval for the Phase 1 trial of OVM-200. With this trial we are looking at three cancers with high unmet clinical need. We see the potential benefits of a vaccination approach both in stimulating the body’s immune system to attack the cancer and also, in future trials, enhancing the efficacy of immune oncology agents. This Phase 1 trial is the first step towards having an effective cancer vaccine”
William Finch, Chief Executive Officer of Oxford Vacmedix added;
“I am delighted that Oxford Vacmedix has reached this significant milestone. The ROP technology pioneered by Dr Shisong Jiang has been developed from an initial concept in the laboratory to now being tested as a treatment for critically ill patients. This progress has been possible due to the great efforts of the team at OVM building on the advice from both our Scientific Advisory Council and from the Clinical Advisory Board for OVM-200. The ROP technology offers a real hope to provide safe and effective therapies to help people with cancer live longer and better lives, and we look forward to seeing the initial results of OVM-200 in the clinic”.
For more information or to arrange an interview, please contact:
William Finch, CEO, Oxford Vacmedix
T: +44 (0)1865 742087 | M: +44(0)7769 903711 | E: wfinch@oxfordvacmedix.com
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 Dr Shisong Jiang. ROPs have been validated as a technology to stimulate broad and strong T cell immunity therefore forming a good platform for cancer therapeutic vaccines and diagnostics.
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 (CBI) that is using the ROP platform in both diagnostics and as adoptive cell therapy
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. Both vaccines will be tested as single agents and in combination with other IO agents.
OVM secured Series A investment from Cancer ROP, a leading South Korean healthcare institution, listed in KOSDAQ, 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 but also in combination with IO agents. For more information, please visit: https://www.oxfordvacmedix.com/
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