Oxford BioMedica has been boosted by the news that regulators in the USA have approved the UK firm’s plans to further develop its cancer vaccine TroVax despite it missing a primary endpoint last year in a Phase III renal cancer trial.

The Oxford-based company says that the US Food and Drug Administration has completed a review of the Phase III TRIST study of TroVax and “acknowledged all of the points raised” by the firm. A year ago, the independent data safety monitoring board for the study recommended that it should carry on but that further vaccinations be discontinued, but now the FDA “has provided a clear path for further development of TroVax in multiple cancer settings”.

Furthermore, the agency acknowledged that “confounding factors may have contributed to the increased number of deaths” in the TroVax arm of the renal cancer study. Also the FDA “accepted that there was no evidence of specific adverse events that could attribute the imbalance of deaths to TroVax”, the company said.

The latest analysis of the TRIST study “further supports the anti-cancer activity of the 5T4-targeted immune response and shows a survival advantage to TroVax”, Oxford BioMedica stated, and the FDA has invited submissions of adaptive Phase II/III trial designs in metastatic colorectal cancer being carried out by partner Sanofi-Aventis.

Oxford BioMedica added that following the positive outcome of the FDA’s review, it is implementing “a broad partnering initiative” and also “progressing discussions with clinical trial networks and clinicians who may conduct independent studies of the vaccine. Chief executive John Dawson said the TRIST study has yielded valuable insights into the potential for TroVax as a therapeutic cancer vaccine, despite not achieving its primary endpoint” and “we are delighted by the outcome of the FDA’s review”.

The agency’s decision “enables us to advance our discussions with prospective partners and the oncology community”, he said, and “we have already received expressions of interest from several pharmaceutical companies that have previously reviewed the programe”. Mr Dawson concluded by saying that “we remain committed to the successful development and commercialisation of TroVax and we are now in a position to widen our partnering initiative such that we maximise the value of this key asset”.