Talaris Therapeutics, Inc. (NASDAQ:TALS) on November 4 announced a clinical update to its phase III Freedom-1 trial evaluating the kidney transplant drug FCR001.
Talaris said the first two patients treated with FCR001 more than 12 months prior to the data cutoff date both successfully weaned off all chronic immunosuppression (IS) without evidence of rejection and with stable kidney function.
SanaCurrents issued a report forecasting a positive outcome for the FREEDOM-1 trial on June 25, 2021, when the stock traded at $13.06 per share. While Talaris plans to report further clinical updates to FREEDOM-1, SanaCurrents is closing its coverage and position in Talaris. On November 4, Talaris’ stock closed at $15.97 per share.
Prior to a procedure, transplant patients receive IS drugs to tamp down the response by the recipient’s immune system. The immune system, however, still recognizes “self” and “non-self” cells or organs. When a non-self appears, such as a transplanted organ, the immune system goes into overdrive and mounts the attack, even with the prior administration of IS drugs.
FCR001 works to induce immune tolerance by creating chimerism, the presence of two complete genomes (or sets of DNA) in the recipient’s body. In a phase II trial, 26 of 37 patients were weaned off IS drugs after receiving FCR001. One woman in the trial gave birth to baby girl after being off immunosuppression drugs for five years.
The FREEDOM-1 trial plans to enroll 120 adult kidney transplant recipients at multiple US sites; the first patient was dosed in September 2020. The primary endpoint is the proportion of FCR001 recipients who are free from immunosuppression, without biopsy proven acute rejection (BPAR) at 24 months post-transplant.