Telesta Therapeutics said today it has cut its workforce by 15%, a move designed to cut costs as the company reviews its strategic options.
Most of the layoffs have taken place at Telesta’s Montreal manufacturing facility. The company had not disclosed how many jobs were eliminated in a statement announcing the workforce reduction. Telesta at deadline had not responded to a GEN query seeking that number.
The cost cutting is occurring more than a month after Telesta received a Complete Response Letter from the FDA concerning its Biologics License Application (BLA) for its bladder cancer treatment MCNA (Mycobacterium phlei cell wall–nucleic acid complex). In the letter, the FDA said Telesta would need to complete another Phase III trial to establish the candidate’s safety and efficacy.
The FDA also encouraged Telesta to meet with agency officials to discuss MCNA development—advice that the company said today it acted on by submitting a request for a “Type A” meeting, with specific questions concerning MCNA’s regulatory path forward.
“Telesta's objective is to obtain clarity on what the FDA will require to consider commercial approval of MCNA,” the company said. “Telesta expects, based on FDA guidance, that the meeting or teleconference (at the FDA's discretion) will be held within 30 calendar days.”
The complete response letter ended earlier plans by the agency to decide on the BLA by MCNA’s Prescription Drug User Fee Act (PDUFA) review goal date of February 27. Telesta submitted its BLA to the FDA on June 29, 2015.
The FDA issued the letter after two advisory panels meeting jointly—the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee—voted 18 to 6 against recommending approval of MCNA.
“Regulatory insight from the U.S. FDA is a critical element in our decision process and in the final selection of a strategic path forward,” Michael Berendt, Ph.D., Telesta’s CEO and chief scientist, said in the statement.
MCNA is indicated for high-risk non-muscle invasive bladder cancer (NMIBC) patients who have failed front-line BCG therapy.
In October, Telesta inked an exclusive licensing agreement for Ipsen to develop and commercialize MCNA for high-risk NMIBC worldwide except the U.S., where Telesta is establishing commercial operations, as well as Canada, South Africa, Mexico, South Korea, and Japan. Ipsen agreed to pay Telesta $10 million upfront and up to $127 million in milestone payments, plus tiered royalties on net sales of MCNA in territories covered by the agreement.