Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
Talaris Staff, Company Courtesy
Talaris Therapeutics is shifting its focus and its pipeline in a restructuring initiative that includes cutting its workforce by one-third.
In the Thursday morning announcement, the biotech stated it will also drop two trials studying its lead candidate, FCR001, in kidney transplant recipients. Talaris cited the pace of enrollment and the associated timeline to critical milestones as the motivation behind its decision.
FCR001 is an investigational allogeneic cell therapy that originally belonged to Novartis’ gene and cell therapy unit. The candidate was developed to change the underlying pathology in organ transplants and eliminate the need for immunosuppressants, which often cause safety issues for patients.
The asset was in three total clinical trials, dubbed FREEDOM-1, FREEDOM-2 and FREEDOM-3. Though it will drop the former two, the Phase II FREEDOM-3 trial will continue as planned. The trial will test the candidate’s ability to induce tolerance in scleroderma, an autoimmune disease that results in inflammation in the skin and other areas of the body.
In a prepared statement, Scott Requadt, CEO of Talaris, stated that because early data for FCR001 in kidney transplant patients was promising, the decision was “exceptionally difficult.”
He highlighted the high unmet need and limited treatment options for scleroderma and the candidate’s potential to become a viable treatment option.
Talaris has had a rocky year with FCR001. In October, the Phase III FREEDOM-1 trial was temporarily paused due to a patient death caused by acute graft-vs-host disease. Two days later, a data monitoring committee cleared the company to continue the trial.
The patient was one of three study participants diagnosed with grade II acute graft-vs-host disease (aGvHD).
According to the press release, the remaining two-thirds of Talaris’ workforce will focus their efforts on the FREEDOM-3 trial and its chemistry, manufacturing, and controls capabilities. The Company stated it is exploring its options to maximize shareholder value, which could include business combinations or divestitures.
