Genvec

Recently, GenVec (GNVC) had to discontinue its final stage trial of TNFerade in patients with pancreatic cancer following an interim analysis.

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 (together 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 develops vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV) and HSV-2 by using its proprietary adenovector technology.

In addition, GenVec is also quite optimistic 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 get up to $213.6 million in the form of milestone payments and royalties on the sale of the drug. In addition, Novartis has bought 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.