|Synta CEO Chen Schor|
Synta Pharmaceuticals ($SNTA) stopped a Phase III trial on a lung cancer drug after investigators realized it was unlikely to meet its goals, news that plunged the biotech into penny-stock territory as management tries to figure out a way forward.
The drug, ganetespib, was in development as a second-line therapy for advanced non-small cell lung adenocarcinoma, working through a late-stage trial testing whether it could best placebo in combination with the standard docetaxel. Looking at data from a preplanned interim analysis, Synta's independent data monitoring committee concluded that the drug had little hope of meeting its primary endpoint of extending overall survival, recommending the company cut its losses and terminate the trial.
Doing so sent Synta's shares down more than 70% overnight, as the failure of the biotech's lead asset leaves it rudderless in the near term. Synta had expected to report final Phase III data on ganetespib next year, planning to file for FDA approval thereafter.
Now the biotech is promising to maintain its support for four investigator-sponsored studies involving ganetespib, testing the drug in ovarian, breast and blood cancers. Results from those trials will help Synta "determine the appropriate path forward for ganetespib," CEO Chen Schor said in a statement, and the company plans to focus on its preclinical assets in the meantime.
"With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward," Schor said.
Schor is Synta's third CEO in about 18 months, taking over for Anne Whitaker, who departed for an executive vice president position at Valeant Pharmaceuticals ($VRX) in April after just 9 months on the job. Whitaker, a veteran of Sanofi ($SNY), took the reins after a string of clinical failures ended the tenure of founder Safi Bahcall in 2014. Tasked with turning the slumping company around, Whitaker planned to get ganetespib through Phase III and onto the market, at the same time investing in the company's crop of early-stage cancer therapies.
- read the statement