Telesta Therapeutics has rounded up $28.6 million to help it see if it can push an experimental bladder cancer drug through to an FDA approval. Consonance Capital Investors, Boxer Capital of Tavistock Life Sciences and Omega Funds all joined in the round for the publicly traded Telesta. Some of the senior execs and board members also chipped in.
They're gambling that a low-profile drug dubbed MCNA can make its way through the FDA to an approval sometime in early 2016 after completing a single-arm Phase III study. The BLA was filed at the FDA at the end of June.
Telesta, the Montreal-based biotech remnant of a company called Bioniche, is founding its hopes on a small study of 129 patients with nonmuscle invasive bladder cancer who were at high risk of recurrence after bacillus Calmette-Guerin failure; otherwise known as BCG vaccine, which is made from a strain of the attenuated live bovine tuberculosis bacillus.
The single arm study of the drug (once called Urocidin), which did not include a placebo arm or other comparison group, concluded with a 25% disease-free survival rate at 1 year and 19% after 2 years.
In a subgroup of patients with papillary only tumors, investigators reported the disease-free survival rate was 35.1% and 32.2% at 1 and 2 years. The median disease-free duration in the 30 responders was 32.7 months, according to the study summary. The progression-free survival rate was 87.3%, 79.8% and 77.7% at 1, 2 and 3 years, respectively, with a progression event in 28 patients. "MCNA was well tolerated and few adverse events led to treatment discontinuation," the researchers reported.
Telesta doesn't know yet just how that single arm study will play with the FDA. But Telesta says that the new funding raise will help it prep for an advisory committee if the FDA requires one. In the meantime, it's hunting for a pharma partner, touting its prospects with a potential near-term product.
Last fall Bioniche was rebranded as Telesta. That move came months after the company spun off its animal health unit. The company was reorganized after former Biovail CEO Bill Wells mounted a proxy fight over the company after it overextended itself. That's when new CEO Michael Berendt came on board.
- here's the release