An optimistic Aveo Oncology recently plotted a path back to Phase III with its thrice-failed cancer drug, but the FDA wants to see more data before signing off on that idea, dealing another blow to the troubled biotech.
According to Aveo, a pair of key advisers to the European Medicines Agency has allowed that TIVO-1 may not have been the kiss of death that the FDA made it out to be two years ago. The biotech says it got a clear signal that the European agency would at least consider an application based on the data at hand.
Aveo Oncology, battered by a long series of clinical setbacks, says it has found a potential path to success with tivozanib, a cancer treatment that has failed in three trials.
Battered by a string of clinical failures, Aveo Oncology is cutting the cord on its internal research operation, ditching two-thirds of its staff and shaking up the C suite.
With former collaborator Astellas Pharma long since out the door, Aveo Oncology has found another partner willing to take a shot on the troubled tivozanib, signing a modest deal with Ophthotech to see how the cancer drug fares in eye diseases.
With the departure of Astellas and now Biogen Idec, Aveo Oncology is fresh out of collaborators, sending the struggling biotech back to the partnering table as it looks to advance an early-stage cancer drug.
Japan's Astellas Pharma has seen enough of tivozanib, washing its hands of the once-promising cancer drug and putting an end to a three-year collaboration with Aveo Oncology.
Aveo Oncology and Astellas Pharma are shutting down a Phase II study of tivozanib in breast cancer after failing to enroll enough patients, the partners announced.
Aveo Oncology's long-troubled tivozanib is unlikely to meet its primary endpoint in a study on colorectal cancer, the company said, sending the biotech back to the drawing board after a high-profile failure in kidney cancer.
In addition to a flurry of investor lawsuits spawned by the FDA's slap-down of its marketing application for the kidney cancer drug tivozanib, Aveo Pharmaceuticals now has an SEC inquiry on its hands. The biotech revealed on Thursday that it had received a subpoena from the SEC 8 days ago demanding "documents and information" on the drug.