MHRA approval for Phase 1 trial of lead cancer vaccine OVM-200

On August 10, 2021 Oxford Vacmedix, the UK-based biopharma company focused on the development of cancer vaccines reported that approval for a Phase 1 trial of OVM-200 has been received from the MHRA (Medicines and Healthcare products Regulatory Authority) (Press release, Oxford Vacmedix, AUG 10, 2021, View Source [SID1234586276]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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".