Talaris, most recently known as Regenerex, will use the funding to launch a Phase III registration trial of its allogenic cell therapy in living donor kidney transplant recipients.
Privately-held Talaris Therapeutics secured $100 million in a Series A financing round as the company undergoes a rebranding with a new leadership team.
Talaris, which was most recently known as Regenerex, said it will use the funding to initiate a Phase III registration trial of FCR001 in living donor kidney transplant (LDKT) recipients. FCR001, an investigational, allogeneic cell therapy that was patented and incubated at the University of Louisville, is being developed to induce or restore patients’ immune tolerance by establishing a stable, chimeric immune system comprised of both donor and recipient cells. FCR001 was previously part of Novartis’ gene and cell therapy unit, until it was dissolved in 2016. FCR001 has received a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration.
At the same time the company announced the $100 million funding, Talaris also announced positive Phase II data of FCR001 in living donor kidney transplant (LDKT) recipients. In the mid-stage trial, Talaris said 70 percent of LDKT patients who received FCR001 were able to safely and durably discontinue immunosuppressive therapy.
The phase II data showed that every tolerized patient has been able to remain free of the use of chronic immunosuppressants for up to 10 years. The median follow-up following transplant was five years, with the longest case being a decade, the company said. Talaris also noted that of the seven LDKT patients had a prior auto-immune disease that led to kidney failure and was tolerized to FCR001, none of them have had a recurrence of their underlying auto-immune disease.
In addition to planning a Phase III clinical trial in LDKT later this year, Talaris said it plans to launch additional Phase II studies in other high-need indications. The company said it will also expand its in-house cell processing capabilities to support these development programs as well as early commercial launch needs.
In addition to the $100 million in funding, Talaris set in place a new leadership structure, including a new chief executive officer. Prior to taking over the helm of Talaris, Scott Requadt was part of the investment team at Blackstone Life Sciences. Previously, he was director of business development at Transform Pharmaceuticals until its acquisition by Johnson & Johnson. Talaris’ new CEO said those who work in the transplant field have had long-standing aspirations of inducing durable, drug-free immune tolerance to a transplanted organ.
“With this substantial financing, Talaris is well positioned to rapidly advance this important therapy into a registration study for LDKT and through additional proof-of-concept clinical trials. The opportunity to change the course of the post-transplant outlook for patients is tremendously exciting, and I am thrilled to join Talaris at this pivotal time in the company’s journey toward this goal,” Requadt said in a statement.
In addition to a new CEO, the company also added to its board of directors and fleshed out its C-suite leadership team. New executives include:
- Chief Medical Officer Nancy Krieger, a transplant surgeon by training. Krieger previously served as the clinical lead at Novartis for the FCR001 program, and earlier in her career was a clinical lead at Bristol-Myers Squibb for the development of transplant drug belatacept.
- Head of Technical Operations Carlos Yuraszeck joins Talaris from Celgene, where he led Quality, Clinical Production and Supply teams within the company’s cell therapy division.
- Head of Human Resources Rick Purdy has more than 25 years of HR experience, most recently as Chief Human Resources Officer at ResCare Corporation.
- Head of New Product Planning Eric Gornstein joins Talaris from Radius Health, where he led commercial insights and analytics efforts.
The funding round was led by Blackstone Life Sciences, with participation from Longitude Capital and Qiming Venture Partners USA.
