Major Setback for GenVec - Analyst Blog

In a major setback, GenVec (GNVC) had to discontinue its final stage trial of TNFerade in patients with pancreatic cancer following an interim analysis. The interim analysis was conducted to ensure if the study should be continued after the 184th death, which was two-thirds of total expected events.

GenVec took this decision based on discussions with a Data Safety Monitoring Board. They came to the conclusion that the trial is unlikely to meet its goal of improving overall survival in patients. The phase III trial, conducted with 330 advanced pancreatic cancer patients, compared treatment with TNFerade (along with standard of care (SOC)) to SOC alone.

It was observed that the TNFerade plus SOC arm demonstrated an 8% lower risk of death compared to SOC alone, which is not statistically significant. However, the company will continue to analyze data from the trial to decide its future strategy on TNFerade. It is also being evaluated for other indications such as head and neck, esophageal and rectal cancer.

Following the disappointment of TNFerade in pancreatic cancer, GenVec will be focusing on its vaccine program.  The company uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV) and HSV-2.

In addition, GenVec is also quite upbeat about its collaboration agreement with Novartis (NVS) for the development of treatments for hearing loss and balance disorders. Preclinical results have found strong potential in GenVec's adenovector technology for the restoration of hearing and balance functions.

Per the agreement, Novartis has acquired worldwide rights to the program, for which it has paid $5 million upfront. GenVec is also eligible to receive up to $213.6 million in the form of milestone payments and royalties on the sale of the drug. In addition, Novartis has purchased shares of GenVec worth $2 million. It will also provide funding to GenVec for conducting research programs for the development of additional adenovectors for hearing loss.

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