Four months after getting a phase 3 kidney transplant trial back on track, Talaris Therapeutics is stopping the momentum again—this time permanently—as part of a strategic review that has claimed a third of the biotech's workforce.
The organ transplantation-focused biotech has conducted a review of all of its programs and has decided to ax the FREEDOM-1 and FREEDOM-2 clinical trials, which were evaluating FCR001 in living donor kidney transplant patients to see if the med could prevent rejection and other complications.
Last year, Talaris paused the FREEDOM-1 trial after a patient who had been diagnosed with grade II acute graft-versus-host disease died. The data monitoring committee ultimately decided that dosing could resume, and the study got back underway in October.
But now, Talaris says that the pace of enrollment and associated timeline to critical milestones has forced the biotech to discontinue the kidney transplantation program. The phase 2 FREEDOM-3 study of FCR001 in scleroderma will continue.
Talaris is also considering other strategic options to maximize shareholder value, which could ultimately include a business combination with another company or the sale of its cell therapy chemistry, manufacturing and controls (CMC) capabilities. No timeline has been set for completion of this strategic review.
Along with the restructuring, Talaris is cutting a third of its workforce. Remaining employees will focus on maintaining the cell therapy CMC capabilities and the FREEDOM-3 trial.
“It was an exceptionally difficult decision to discontinue further development of FCR001 in kidney transplantation tolerance despite the promising early data,” said CEO Scott Requadt. “While we are disappointed that our work in kidney transplantation will not continue, given the potential of FCR001 to induce durable tolerance, we intend to continue its evaluation for scleroderma, which remains a very high unmet medical need for which there are limited treatment options.”
Talaris had about $181.3 million in cash on hand as of the end of 2022.