The company, Talaris Therapeutics Inc., has listed its shares on the NASDAQ Stock Market exchange under the ticker symbol “TALS.”Ěý

Talaris is working to develop and market , which is intended to help transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives. The therapy was invented at UofL by researcher and innovator Suzanne Ildstad, who founded the company and now serves as its chief scientific officer.

The therapy is designed to prevent organ rejection without the morbidity and mortality that has been associated with the use of lifelong anti-rejection medicines. Talaris has an exclusive license to the technology, which was developed by Ildstad’s lab at UofL, through .

Immunosuppressants help prevent rejection of the transplanted organ, but can cause serious side effects, including high blood pressure, diabetes, high cholesterol, neurological effects, increased risk of infection and decline in kidney function over time.

With this therapy, the goal is “helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life,” Ildstad said previously. “The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.”

FCR001 consists of stem and immune cells taken from the organ donor and processed at Talaris’ GMP cell processing facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient where these two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

“This technology could help transplant patients live fuller, healthier lives,”Ěýsaid UofL Executive Vice President for Research and Innovation, Kevin Gardner.Ěý“This UofL research, in the hands of strong industry partners and backed by sophisticated life sciences investors and now public shareholders, is a big step in advancing our health.”Ěý

Talaris has secured significant funding over the past two years. In 2019, the company closed a , which it used to hire staff and initiate a Phase 3 clinical trial for its therapy — the last step before applying for FDA approval.

A year later, it to support that trialĚý as well as two other Phase 2 trials that are expected to begin in the second half of 2021, including a planned Phase 2 trial of FCR001 in diffuse cutaneous systemic sclerosis, a severe form of the rare autoimmune disease scleroderma.

The company, Talaris Therapeutics Inc., plans to use the series B funding to support a Phase 3 clinical trial — the last step before applying for FDA approval. This series A funding round announced last year to hire staff and initiate the trial.

Talaris recently began in that trial of the unique cell therapy, called FCR001, which allows living-donor kidney transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives.

Immunosuppressants help prevent rejection of the transplanted organ, but can cause side effects, including high blood pressure, diabetes, high cholesterol, neurological effects, increased risk of infection and decline in kidney function over time.

“This technology could help transplant patients live fuller, healthier lives,”Ěýsaid UofL Executive Vice President for Research and Innovation, Kevin Gardner.Ěý“This UofL research, in the hands of strong industry partners and backed by investors, is a big step in advancing our health.”Ěý

FCR001 consists of stem cells taken from the organ donor and processed at the Talaris facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient. These two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

The new funding also will advance aĚýplanned Phase 2 trial of FCR001 in diffuse systemic sclerosis, a severe form of the rare autoimmune disease scleroderma.

Talaris, formerly known as Regenerex LLC, was founded by UofL researcher and innovator Suzanne Ildstad to commercialize the pioneering work of her team at the university. She now serves as Talaris’ chief scientific officer.

“This financing moves us one step closer to helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life,” Ildstad said of the earlier Phase 3 trial financing. “The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.”

In an earlier Phase 2 trial, FCR001 allowed 70% of living donor kidney transplant patients durably to be weaned off all of their immunosuppression treatments.

The Phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.

The unique cell therapy, called FCR001, allows living-donor kidney transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives.

Immunosuppressants help prevent rejection of the transplanted organ, but can cause side effects, including high blood pressure, diabetes, high cholesterol, neurological effects and increased risk of infection. They also are toxic to the kidneys, causing decline in kidney function over time.

FCR001 consists of stem cells taken from the organ donor and processed at the Talaris facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient. These two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

Talaris Therapeutics Inc., formerly known as Regenerex LLC, is developing and commercializing FCR001. UofL researcher and innovator Suzanne Ildstad founded the company to commercialize the pioneering work of her team at the university and now serves as Talaris’ chief scientific officer.

“We are very gratified to have reached the milestone of treating the first patient in our pivotal Phase 3 clinical trial as we work to make this therapy broadly available to patients receiving a kidney transplant from a living donor,” Ildstad said. “Thanks to our talented team, investors and the research infrastructure at UofL, we have moved incredibly quickly over the past year to both initiate this trial and to plan additional clinical studies of FCR001 in other indications.”

Last year, Talaris raised $100 million from investors to hire staff and initiate the Phase 3 trial evaluating the safety and efficacy of a single dose of FCR001 in living donor kidney transplant recipients.

In an earlier Phase 2 trial, FCR001 allowed 70% of living donor kidney transplant patients durably to be weaned off all of their immunosuppression treatments. The first patient successfully dosed with FCR001, Robert Waddell, has been off immunosuppressants for a decade with no signs of organ rejection.

“It makes me forget I was ever sick,” Waddell said.Ěý“I feel as healthyĚýas I ever have.”

The Phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.

“We are rapidly expanding our network of trial sites, with five sites now active and a planned 10 sites active by the end of this year,” said Scott Requadt, chief executive officer of Talaris. “We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients a future potentially free from chronic immunosuppression.”

More information about the trial is .Ěý

, formerly known as Regenerex LLC, is using technology developed at UofL to allow living donor kidney transplant recipients to stay off immunosuppression drugs for the rest of their lives. In a Phase 2 study, the cell therapy, called FCR001, allowed 70% of living donor kidney transplant patients to be durably weaned off all of their immunosuppression treatments.

The unique cell therapy technology is a result of pioneering research conducted at UofL by the team of Suzanne Ildstad. Ildstad has spent 21 years as a “” researcher at UofL. She founded Talaris around her research and is the company’s chief scientific officer.

“This financing moves us one step closer to helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life,” Ildstad said. “The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.”

The technology developed by Ildstad’s team was patented at UofL and is exclusively licensed by Talaris from UofL’s Ěý. Talaris plans to use the new funding to carry out a phase 3 clinical trial of FCR001. Longer term, the company plans to study whether FCR001 could be used for other organ transplants.

Talaris has about 25 employees in Louisville. Talaris’ research and cell processing facilities are based at UofL and the company also has a corporate office in Boston. As part of its licensing agreement with Talaris, the university will receive royalties from sales of any licensed products.

“This cutting-edge UofL research can have a significant impact on human health,”Ěýsaid UofL President Neeli Bendapudi.Ěý“This is a prime example of ourĚýability to work with industry partners and investors to help turn innovative research into valuable new products.”

Check out footage from the press conference:Ěý