Synta CEO resigns before key data readouts
This article was originally published in Scrip
Synta Pharmaceuticals president, CEO and board member Safi Bahcall submitted his immediate resignation, the company reported following the stock market's close on 3 March, sending Synta down 6.5% in after-hours trading to $5.75 per share.
Dr Bahcall's resignation comes within just days or weeks of an overall survival readout expected in early 2014 from the company's Phase IIb GALAXY-1 clinical trial for the heat shock protein 90 (Hsp90) inhibitor ganetespib. Synta is scheduled to release its 2013 financial report and corporate update on 11 March.
In addition to a near-term GALAXY-1 update, interim results from the Phase III GALAXY-2 trial are expected during the second half of 2014. The study's design and patient population were shaped by the results of GALAXY-1. Both clinical trials are evaluating ganetespib plus docetaxel versus docetaxel alone in the treatment of non-small cell lung cancer (NSCLC).
Lexington, Massachusetts-based Synta will be run by a newly formed executive committee of the company's board of directors until the committee hires Dr Bahcall's replacement.
The executive committee will be helmed by committee and board chairman Keith Gollust, board member and retired Johnson & Johnson vice chairman Robert Wilson, and newly appointed board member Paul Friedman, who retired from his 13-year role as CEO of cancer drug developer Incyte in January.
"We expect this transition to produce no delay in our advancement of ganetespib," Mr Gollust said in a statement from Synta.
Sagient Research's BioMedTracker analyst service reduced the likelihood of US FDA approval (LOA) for ganetespib by 3% to 66% in October based on a GALAXY-1 update that showed the drug's overall survival benefit decreasing over time. The LOA is 1% below average for drugs in similar stages of development.
Synta said in October that it would be able to report final data for the GALAXY-1 trial in early 2014 after the study reached 70% of overall survival events.
Synta expanded enrollment in GALAXY-2 from 500 to 700 patients in November to make up for differences in patients enrolled at two Eastern European countries versus the general study population (scripintelligence.com, 4 November 2013).
The company grossed $52.5m from a stock offering in November to support the GALAXY program (scripintelligence.com, 14 November 2013).
"We discussed the [management] changes with Mr Gollust and Synta is in preparations now for the next stages of its development as a late-stage biotechnology company," Roth Capital analyst Joseph Pantginis wrote in a 3 March report.
The addition of Dr Friedman to Synta's board and executive committee should position the company to attract "top-notch" talent, Dr Pantginis noted.
"While the decisions that were made were quite tough within the company, the clinical development team remains intact," he wrote.