When Transgene CEO Philippe Archinard signed up for the European commercialization rights to Jennerex's oncolytic virus immunotherapy JX-594 in a $116 million deal back in 2010, he looked ahead to a marketing application in 2015 and a potential blockbuster market on the continent worth more than $1 billion. Today, he would probably settle for far less.
Archinard was forced to concede that a Phase IIb trial for the drug, an engineered antitumor virus now dubbed Pexa-Vec, failed the primary endpoint of overall survival in advanced liver cancer patients compared to best supportive care. The CEO didn't detail the data but says that a decision on whether to move ahead into Phase III is still on the table and will be made in the final quarter of the year.
Shares of Strasbourg, France-based Transgene slid 14% on the news.
"It is a disappointment that TRAVERSE did not reach its primary survival endpoint for this population of patients who have so limited treatment options," said Archinard in a statement. "A detailed analysis of the final results of TRAVERSE along with other ongoing studies will be conducted by the end of the year. At this stage, the decision to move Pexa-Vec into Phase III in first line HCC next year is still expected to be made in Q4 2013."
Laurent Fischer, the CEO of San Francisco-based Jennerex, also noted that additional data from Phase II studies in other liver cancer trials as well as in kidney, colorectal and ovarian cancer are anticipated.
The therapy is designed to mount a three-pronged attack on cancer: combating cancer cells through viral replication, cutting the blood supply to tumors and spurring an immune response to fight the cancer. Back in 2009 Jennerex reported signs of efficacy and safety in a dose-escalating Phase I trial. Transgene took an unspecified stake in Jennerex when it forged its pact.
- here's the release from Transgene
- here's the release from Jennerex