Transgene has been boosted by the news that regulators have granted fast-track status to the French firm’s investigational lung cancer vaccine.
The US Food & Drug Administration has given fast-track development designation to TG4010 (MVA-MUC1-IL2), an immunotherapy which uses the Modified Vaccinia Anakara virus vector, for the first-line treatment of advanced non-small cell lung cancer in combination with chemotherapy. This also allows for the TG4010 Biological License Application to be considered on a rolling basis, letting the FDA review sections of the submission as they are completed.
The move follows the agency’s earlier clearance allowing Transgene to proceed to a late-stage trial based on positive clinical data from a Phase IIb trial of TG4010. Chief executive Philippe Archinard said that getting fast-track status “represents a key achievement in our regulatory strategy”.
He noted that Transgene is “actively preparing the next development steps for the product and look forward to working closely with the FDA”. The next step for the firm now is to bag a partner and Mr Archinard said that discussions have progressed. “We hope to reach a collaborative agreement around year-end”, he added.
