Another day, another biotech IPO. This time, it’s cell therapy player Talaris Therapeutics, which raised $150 million in a Nasdaq debut to fuel the company’s lead asset, an off-the-shelf cell therapy it hopes will transform the standard of care in organ transplant, as well as some disorders of the blood, immune system and metabolism.
Talaris is developing its lead asset, FCR001, to combat organ rejection and treat scleroderma, a group of rare autoimmune diseases of the joints and connective tissue. The treatment, an allogeneic stem cell therapy, is made of stem and immune cells from a healthy donor. In the case of organ transplantation, this donor is the same person who donated the organ.
The biotech will use about $130 million of the IPO proceeds to push FCR001 through a phase 3 study involving 120 adults who have undergone a kidney transplant from a living donor, according to a securities filing. In this trial, the patients are receiving FCR001 the day after transplant. The goal is to gauge the potential of FCR001 to induce durable, drug-free immune tolerance—that is, making the body “see” a transplanted organ as part of itself rather than a foreign object it should reject.
“The goal here is—if this therapy works—then a kidney transplant recipient essentially will have two immune systems,” said Talaris CEO Scott Requadt, in a previous interview. One of the immune systems is their own, while the second is made up of immune cells produced when the donor stem cells take root in the patient’s bone marrow, he said. Talaris calls this a “chimeric immune system.”
The hope is that this treatment will eliminate the need for lifelong immunosuppressive drugs in patients who have undergone an organ transplant.
“Transplants sound easy, but patients need to take up to 25 pills a day,” said Suzanne Ildstad, M.D., founder and chief scientific officer of Talaris, in a previous interview. And patients don’t just need to take dozens of pills—they also have to deal with the side effects from those drugs, such as high blood pressure, diabetes, high cholesterol and infections that could be life-threatening, Ildstad said.
About $40 million of the new funding will go into other R&D for FCR001, including a study testing the treatment’s ability to induce immune tolerance when given up to one year after a kidney transplant, Talaris said in the securities filing.
Another $30 million will bolster the company’s manufacturing capacity for the potential approval, and launch of FCR001 and $25 million will fund preclinical development of earlier-stage programs.
One of those programs is exploring Talaris’ approach in organs transplanted from deceased donors. The company is keeping the other preclinical programs under wraps, with plans to unveil the first by the end of the year.