Talaris, Inc.

Established in 2002 and based in Kentucky, US, Talaris, Inc. , formerly known as Regenerex, operates as a biotechnology company that develops cellular therapies. The company was founded by Chief Scientific Officer Suzanne Ildstad. In 2008, Regenerex initiated Phase 2 clinical trial of allogeneic cell therapy (FCR001) in living donor kidney transplant (LDKT) patients.

In 2010, the first FCR001-dosed LDKT patient was successfully weaned off all immunosuppression. He remained immunosuppression-free. In 2013, Regenerex partnered with Novartis to advance trials of FCR001. In 2019, Regenerex relaunches as Talaris with $100 million financing and expanded their leadership team, to advance FCR001 through multiple later-stage clinical trials.

In October 2020, Talaris Therapeutics raised USD 115 million in Series B funding co-led by Surveyor Capital and Viking Global Investors. In May 2021, the company raised USD 150. 03 million in an IPO conducted on Nasdaq and listing the company under ticker TALS. Talaris is a late-clinical stage, cell therapy company developing methods of allogeneic hematopoietic stem cell transplantation (allo-HSCT) that aims to transform solid organ transplantation, certain autoimmune diseases, and certain non-malignant blood, immune, and metabolic disorders.

Its product candidate, FCR001, is a one-time, investigational cell therapy that contains three distinct cell types: hematopoietic stem cells, facilitating cells, and aßTCR+ T-cells, that rebuild the hematopoietic and immune system of the recipient. The company is advancing three clinical programs of Facilitated Allo-HSCT Therapy: FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the US of FCR001 in 120 adult living donor kidney transplants (LDKT) recipients; FREEDOM-2, a Phase 2 trial that evaluates the potential for FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, a process called delayed tolerance; and FREEDOM-3, a Phase 2 trial exploring the clinical activity of FCR001 in patients with a severe form called scleroderma, a complex and heterogeneous systemic autoimmune disease affecting multiple tissues and organs. Talaris, Inc. plans on utilizing the Series B funding obtained in 2020 to support the ongoing Phase 3 trial of Talaris’ lead candidate, FCR001, and advance the planned Phase 2 trial of FCR001 in diffuse systemic sclerosis (SSc).