immune tolerance

Company overview

Talaris is developing a single-dose cell therapy that seeks to produce durable immune tolerance to both an individual’s own tissues as well as donated organs from another individual.

Ground-breaking clinical study

In a groundbreaking Phase 2 clinical study conducted between 2009 – 2016, our FCR001 therapy enabled 70% of living donor kidney transplant (LDKT) recipients to discontinue all immunosuppressive drugs by 12 months after their kidney transplant. We have followed some of these patients for more than ten years. To date, no patient that was able to discontinue immunosuppression has had to resume immunosuppression.Based on these data, we have launched a Phase 3 trial in LDKT recipients at Centers of Excellence around the U.S. Learn more about this clinical trial here. We are also exploring our therapy’s potential to induce or restore immune tolerance in certain types of severe autoimmune or immune-mediated disorders, as well as in other organ transplant settings. Talaris has recently received IND acceptance to launch a Phase 1/2a trial of FCR001 in rapidly progressive diffuse scleroderma. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital, and Qiming Venture Partners.

“To date, no patient that was able to discontinue immunosuppression has had to resume immunosuppression.”

— Suzanne Ildstad, MD

Our approach

Talaris’ proprietary technology allows candidates for bone marrow transplants to receive hematopoietic stem cells (HSCs) safely from unmatched and unrelated donors, without the toxicity and risks of a traditional bone marrow transplant.

The facilitating cells present in the Talaris product act as nurse cells to the HSCs, directing these cells to the niche in the bone marrow to facilitate engraftment. Once engraftment occurs, the donor’s HSCs produce new immune cells that coexist with the recipient’s cells. These cells help to reset the recipient’s immune system and allow the recipient to recognize the transplanted kidney as “self”.

cGMP Manufacturing

Talaris processes all FCR001 patient samples at our dedicated cGMP cell processing facility in Louisville, KY

Our Name

Talaris is adapted from “talaria,” the winged sandals worn by Greek messenger god Hermes. These sandals protected Hermes and delivered him to safety. In a similar way, the facilitating cells central to our platform protect and deliver other immune cells to safety within the recipient patient. It’s also more broadly symbolic of how we hope to help our patients live better lives “beyond the transplant”.