Talaris Therapeutics bags another $115M to curb immunosuppression in organ transplant patients
Just over a year after securing a $100 million Series A round, Talaris Therapeutics is back with a $115 million Series B to fuel its mission of making organ transplants safer.
CEO Scott Requadt said he’s seen “dramatic progress” since the Series A. In the last 18 months, the biotech has crossed the Phase III starting line with its lead drug, FCR001, in living donor kidney transplant recipients. Plus, it “laid the groundwork” for two Phase II studies, he noted.
Transplant patients are often put on immunosuppression regimens to prevent rejection of the donated organ, which exposes them to infections.
“Covid has changed everything for all of us. But in particular, it’s a perfect storm for organ transplant recipients because they’re on chronic immunosuppression,” Requadt said. The goal, he added, is to restore immune tolerance without the body rejecting the organ.
To do so, the company’s processing bone marrow. The approach is the brainchild of Suzanne Ildstad, director of the University of Louisville’s Institute for Cellular Therapeutics, who launched Regenerex in 2002 to build out the idea. Novartis helped upgrade manufacturing and shape a Phase II protocol before shutting down its cell and gene therapies unit in 2016.
When funding ran dry, Ildstad turned to Clarus (now Blackstone Life Sciences), which led a $100 million Series A to propel her work to Phase III. Requadt, who spent 13 years as Clarus’ managing director, became CEO of the nominally new company, Talaris.
“It was one of the most unique things that I’ve seen as an investor in 13 years,” he told Endpoints News. “And so I decided to put up my hands and become a first-time CEO.”
Requadt plans on dumping Talaris’ recent Series B into its ongoing Phase III trial in living donor recipients, as well as prospective Phase II trials in diffuse systemic sclerosis and patients who have previously received a living donor kidney transplant. The Phase III will enroll up to 120 donor-recipient pairs at 15 sites in the US, Requadt said. He declined to comment on the timeline of the trial, which is still in early stages. Both Phase II trials are expected to begin next year.
In a Phase II study, 70% of 37 living donor kidney transplant patients given FCR001 were weaned off all of their immunosuppression treatments, according to Talaris. And out of 7 patients with a pre-existing autoimmune disease who quit immunosuppression, none had a recurrence, according to the company.
In the upcoming Phase II delayed tolerance trial, researchers will test whether they can recruit patients who received transplants in the last 12 months, take some cells from their donors, and make a product to induce immune tolerance.
“Initially, we’re going to focus on patients who are within 12 months of a transplant, but we may well explore… longer delays down the line,” Requadt said.
The Series B was led by Surveyor Capital and Viking Global Investors. Blackstone chipped in again this round, as well as Longitude Capital and Qiming Venture Partners USA. Other new investors include Cormorant Asset Management, Invus, funds and accounts managed by BlackRock, Eventide Asset Management, Logos Capital, Aisling Capital and Pamoja Capital.
“Immunosuppressive agents are toxic to the kidney, and as a result you typically need to have kidney transplant every 15 years or so. And if we’re able to discontinue the drugs that are toxic to the kidney, you know, the potential is that people would benefit from a single transplant for much longer periods of time,” Requadt said. “Maybe even one kidney for life.”