Policy & Regulation
Talaris Therapeutics Closes USD 100m series A Financing to Advance Its Novel, Allogeneic Cell Therapy Through Late-Stage Clinical Development
22 April 2019 - - US-based biotechnology company Talaris Therapeutics, Inc has closed a USD 100m series A financing, the company said.

The series A funding will be used to advance the company's proprietary, one-time, allogeneic cell therapy, FCR001, into later-stage clinical development in multiple immune-related indications. The financing was led by Blackstone Life Sciences, with participation from Longitude Capital and Qiming Venture Partners USA.

Talaris, formerly Regenerex, will leverage this funding to conduct a Phase 3 registration trial of FCR001 in living donor kidney transplant recipients, as well as additional Phase 2 studies in other high-need indications, following the company's promising Phase 2 data also announced TODAY.

In the Phase 2 trial, 70 % of LDKT patients who received FCR001 were able to safely and durably discontinue immunosuppressive therapy.

The company will also expand its in-house cell processing capabilities to support these development programs as well as early commercial launch needs.

Requadt, Talaris' new CEO, is an experienced biotech leader and life sciences investor with nearly 20 years of industry experience.

Prior to joining Talaris, he was part of the investment team of Clarus Funds (now Blackstone Life Sciences) for 13 years, having most recently served as Managing director.

He remains a Venture Partner with Blackstone Life Sciences. Previously, he was director, Business Development at Transform Pharmaceuticals until its acquisition by Johnson and Johnson. He started his career as a mergers and acquisitions lawyer at Davis Polk and Wardwell.

The company also named its the founding board of directors comprised of independent chairman, Francois Nader, M.D., previously CEO of NPS Pharmaceuticals, Inc.; independent director, Geoff MacKay, CEO of AVROBIO, Inc.; Scott Requadt, newly appointed CEO of Talaris; Nicholas Galakatos, Ph.D., Head of Blackstone Life Sciences; Sandip Agarwala, Managing director of Longitude Capital; Mark McDade, Managing Partner at Qiming Venture Partners USA; and Suzanne Ildstad, M.D., Founder and chief scientific officer of Talaris.

Ildstad, a transplant surgeon by training, developed the FCR001 platform while at the Institute for Cellular Therapeutics at the University of Louisville.

Chief Medical officer Nancy Krieger, M.D., a transplant surgeon by training, has over 15 years of diverse global development experience in the pharmaceutical industry. Dr. 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.

SVP 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.

He brings to the company over 25 years of experience in manufacturing and quality systems spanning cell therapy, biologics and small molecules.

VP of Human Resources Rick Purdy has more than 25 years of HR experience, most recently as Chief Human Resources officer at ResCare Corp.. His earlier career spans several other leading companies such as General Electric and Aetna.

Head of New Product Planning Eric Gornstein joins Talaris from Radius Health, where he led commercial insights and analytics efforts. He has over 20 years of experience in market analytics and commercial planning.

FCR001 is an investigational, allogeneic cell therapy developed by Talaris to induce or restore patients' immune tolerance. FCR001 builds on over 30 years of research by the company's founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders.

It was patented and incubated at the University of Louisville. The lead indication for FCR001 is to induce durable immune tolerance in living donor kidney transplant recipients. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy designation from the US Food and Drug Administration.

Talaris Therapeutics, Inc., formerly Regenerex, is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe auto-immune and immune-mediated disorders.

Talaris was founded on technology discovered and developed by Dr. Suzanne Ildstad and operates its own cell processing facility in Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA and maintains corporate offices in Boston, MA and Louisville, KY.