News

Talaris Therapeutics Closes $115 Million Series B Financing

Proceeds to support ongoing Phase 3 registration trial of Talaris’ lead product candidate FCR001 in living donor kidney transplant, and additional Phase 2 trials next year in autoimmune disease and organ transplant

Financing co-led by Surveyor Capital (a Citadel company) and Viking Global Investors, with multiple new investors participating –

BOSTON, Mass., and LOUISVILLE, Ky., October 6, 2020 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, announced the closing of a $115 million Series B financing co-led by Surveyor Capital (a Citadel company) and Viking Global Investors.

Other participants in the financing included new investors Cormorant Asset Management, Invus, funds and accounts managed by BlackRock, Eventide Asset Management, Logos Capital, Aisling Capital and Pamoja Capital, as well as Talaris’ Series A investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA.

“Over the past 18 months, Talaris has made dramatic progress in assessing the potential of our unique cell therapy across multiple therapeutic areas. We have initiated a pivotal trial for our lead indication in living donor kidney transplant, laid the groundwork for two additional Phase 2 studies, greatly expanded our team and bolstered our wholly in-house cell processing capabilities,” said Scott Requadt, Chief Executive Officer of Talaris. “We are grateful for the support of this outstanding syndicate of investors to help us advance our immune tolerance programs through important clinical milestones in both organ transplant and autoimmune disease.”

The financing will support the ongoing Phase 3 trial of Talaris’ lead candidate, FCR001, which is now enrolling first-time living donor kidney transplant recipients at sites across the U.S. Additionally, the funds will advance a planned Phase 2 trial of FCR001 in diffuse systemic sclerosis (SSc), a severe form of the rare autoimmune disease scleroderma, as well as a future Phase 2 trial of FCR001 in individuals who have previously received a living donor kidney transplant.

“With this financing Talaris has assembled a world-class investor syndicate that shares our vision of the transformative potential of durable, drug-free immune tolerance,” said Francois Nader, M.D., Chairman of the Board. “We believe Talaris’ therapy could represent a paradigm shift across multiple therapeutic areas.”

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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 autoimmune and immune-mediated disorders. Talaris is backed by a number of leading life sciences investors and maintains corporate offices in Boston, Mass., and its cell processing facility in Louisville, Ky. www.TalarisTx.com .

Media Contact:

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

 

Talaris Therapeutics Announces Collaboration with Kentucky Organ Donor Affiliates to Advance Preclinical Study of Tolerance Induction to Organs from Deceased Donors

BOSTON, Mass., and LOUISVILLE, Ky., September 14, 2020 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced a collaboration with Kentucky Organ Donor Affiliates (KODA). KODA is an independent, non-profit organ and tissue procurement organization that facilitates deceased donor transplants throughout Kentucky, southern Indiana and western West Virginia. The collaboration will advance preclinical studies of the potential of Talaris’ allogeneic cell therapy to induce immune tolerance to an organ from a deceased donor.

Organ donation from deceased donors makes possible more than 80 percent of solid organ transplants in the U.S. These transplants are frequently lifesaving, but they bring the burden of lifelong immunosuppression for organ recipients, which puts patients at heightened risk of infection as well as a number of other potentially serious side effects. Additionally, immunosuppressant drugs are toxic to the kidneys over time, which can result in declining kidney function and necessitate another organ transplant.

“Talaris’ novel cell therapy, FCR001, has shown promising potential to eliminate the need for immunosuppression among recipients of kidney transplants from living donors. Our collaboration with KODA will be an important step toward potentially extending this promise to recipients of organ transplants from deceased donors as well,” said Scott Requadt, Chief Executive Officer of Talaris.

Within the collaboration, KODA, after authorization from the donor’s family, will recover vertebrae from deceased organ donors. Researchers at Talaris will then isolate stem cells from the vertebrae, with the goal of demonstrating the feasibility of producing FCR001 from vertebral bone marrow. These preclinical studies will serve as a first step toward enabling future clinical studies to evaluate whether FCR001 administered alongside organ transplantation can induce durable immune tolerance to an organ from a deceased donor.

“The generosity organ donors and their families display is measureless. By initiating this collaboration with Talaris, we hope to further honor their gift by advancing an important treatment for transplant recipients with the potential to improve many individuals’ lives,” said Julie Bergin, RN, BSN, MHA, President & Chief Executive Officer of KODA.

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

About Kentucky Organ Donor Affiliates (KODA)

Kentucky Organ Donor Affiliates is dedicated to saving lives through organ and tissue donation and transplantation. KODA is an independent, federally designated, non-profit organ and tissue procurement organization formed in 1987. KODA was recognized by Louisville Business First as the Nonprofit of the Year in 2011. KODA’s mission is to provide organ and tissues to those in need and to maintain a profound respect for those who gave. KODA serves 114 counties in Kentucky, 4 counties in southern Indiana and 2 counties in western West Virginia. For more information visit donatelifeky.org  or call 1-800-525-3456.

Media Contacts:

Talaris:
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

KODA:
Shelley Snyder
Vice President of Strategic Partnerships, Kentucky Organ Donor Affiliates
S.snyder@kodaorgan.org
(502) 322-5401

Erin Jones
in.Mode Marketing
erin@inmodemarketing.com
(502) 774-0767

 

Talaris Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

Enrollment continues with multiple trial sites now opening across the U.S.

BOSTON, Mass., and LOUISVILLE, Ky., July 22, 2020 –  Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced that the first patient has been dosed in the FREEDOM-1 Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. The trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

“We are proud to have begun dosing in Talaris’ pivotal FREEDOM-1 trial, and grateful to the clinicians, patients and wider kidney transplant community who have joined in our efforts to advance this potentially transformative therapy,” said Scott Requadt, Chief Executive Officer of Talaris. “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. We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients the potential of a future free from chronic immunosuppression.”

The FREEDOM-1 trial is expected to enroll 120 adult LDKT recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical Centers of Excellence: Northwestern Memorial Hospital (Chicago, Ill.); Scripps Clinic (La Jolla, Calif.); Duke University Medical Center (Raleigh, N.C.); MedStar Georgetown University Hospital (Washington, D.C.); and University of Nebraska Medical Center (Omaha, Neb.).

“The ability to induce durable, drug-free immune tolerance to a transplanted organ would be transformative for the thousands of patients who undergo living donor kidney transplant each year,” said Joseph R. Leventhal, M.D., Ph.D., Interim Chief of Organ Transplantation and Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine, and a principal investigator for the FREEDOM-1 trial. “In our earlier studies of FCR001, we’ve seen promising long-term safety and efficacy, with some patients now off all immunosuppression more than 10 years post-transplant — findings which we now hope to reproduce in a larger group of patients in this Phase 3 trial.”

More information about the FREEDOM-1 trial can be found at: https://freedom1study.com/

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients, FREEDOM-1, is now enrolling patients; more information can be found at: http://freedom1study.com/

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

FDA Approves Talaris Therapeutics’ IND for its Allogeneic Cell Therapy FCR001 to be Evaluated in Patients with a Severe Form of Scleroderma

BOSTON, Mass., and LOUISVILLE, Ky., July 8, 2020Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the evaluation of Talaris’ novel cell therapy FCR001 in the treatment of diffuse systemic sclerosis (SSc), a severe form of the rare autoimmune disease scleroderma. Approval of this IND allows Talaris to initiate a Phase 1/2a trial at sites across the U.S., including Duke University and the University of Michigan.

“We’re very eager to study the tolerogenic potential of FCR001 for patients with severe autoimmune disease,” said Scott Requadt, Chief Executive Officer of Talaris. “Individuals with diffuse cutaneous systemic sclerosis, a subset of scleroderma with high morbidity and mortality, are in great need of safe and effective, disease-modifying, treatment options. We believe FCR001 could represent an important new approach to treating this serious condition.”

Scleroderma, which derives from the Greek words “sclero,” meaning hard, and “derma,” meaning skin, is a rare and potentially fatal chronic autoimmune disease which causes progressive scarring, or fibrosis, of the body’s connective tissues. Scleroderma can either be localized or systemic. Systemic scleroderma, also called systemic sclerosis (SSc), is further divided into the limited cutaneous subset and the diffuse cutaneous subset, depending on the degree of skin involvement. Both types affect the skin and vital internal organs, especially the lungs, kidneys, gut and heart, resulting in organ dysfunction. Patients with the diffuse subset generally have rapidly progressive skin and internal organ involvement and have worse outcomes than the limited subtype.

Based on encouraging data from randomized clinical trials, autologous hematopoietic stem cell transplant (HSCT) is increasingly used to treat severe cases of diffuse cutaneous SSc, where it has been shown to halt organ damage and induce clinical remission. However, because patients are transplanted with their own stem cells, there is a risk of disease recurrence, and patients typically must first undergo full myeloablative conditioning with or without total body irradiation, which is associated with direct organ toxicity and increased risk of future cancers.

Talaris’ allogeneic cell therapy, FCR001, is a novel, one-time treatment intended to induce immune tolerance in the recipient and which can be used across all levels of donor-recipient HLA mismatch. Treatment with FCR001 is preceded by non-myeloablative conditioning. In a Phase 2 clinical trial in de novo living donor kidney transplant recipients, FCR001 resulted in durable immune tolerance in 70% of the 37 recipients treated; these individuals were able to successfully discontinue their anti-rejection medications and no tolerized patient has had to resume immunosuppression (median follow-up of over 5 years, longest follow-up is over 10 years). Furthermore, seven of the successfully tolerized patients had kidney failure due to an underlying autoimmune disease, and none of these patients has experienced recurrence of their underlying autoimmune disease post-treatment. Based on these encouraging data and its broad therapeutic potential in autoimmune disease, FCR001 will be evaluated in a planned Phase 1/2a trial of patients with diffuse cutaneous SSc.

“A safe, allogeneic stem cell transplant treatment using nonmyeloablative conditioning could offer important additional benefits over current autologous HSCT as a treatment for this severe form of systemic sclerosis,” said Keith Michael Sullivan, M.D., Professor of Medicine at Duke University Medical School.

“The diffuse cutaneous systemic sclerosis subset I see in my practice have very limited treatment options. Autologous stem cell transplant has demonstrated the potential to induce durable remissions in randomized clinical trials, but involves significant risks to the patients,” said Dinesh Khanna, M.D., M.Sc., Director of the Scleroderma Program and Professor of Medicine at the University of Michigan Medical School. “I am excited to participate in this clinical trial of FCR001, and hopeful that it could result in a safer and more durably effective treatment for these patients.”

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients, FREEDOM-1, is now enrolling patients; more information can be found at: http://freedom1study.com/

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

###

Update on Talaris’ Phase 2 Study of FCR001 in Living Donor Kidney Transplant Recipients to be Presented at ATC Virtual Congress

– Data reinforce potential of FCR001 to induce long-lasting immune tolerance to donated organ –

BOSTON, Mass., May 29, 2020 –  Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, announced the presentation of updated data from long-term follow-up of its Phase 2 study of FCR001 in living donor kidney transplant (LDKT) recipients during an oral presentation at the ATC Virtual Congress on Saturday, May 30, 2020.

The data show that 26 of 37 (70%) of LDKT recipients of FCR001 were able to be weaned off all of their immunosuppression treatments. The degree of HLA mismatch (spanning 0/6 to 6/6) between the donor and the recipient did not affect either the safety or the efficacy of the therapy. Every tolerized patient has subsequently remained off all chronic immunosuppression, now with a minimum follow-up of three years for all trial subjects, median follow-up of over five years, and the longest follow-up of almost 11 years. Long-term subjects off immunosuppression have shown no evidence of immune defect, and can be safely and effectively vaccinated. The findings will be presented by Joe Leventhal, M.D., Ph.D., a professor of surgery in organ transplantation at Northwestern University Medical School, director of the living donor renal transplant program at Northwestern Memorial Hospital and lead investigator for the trial.

The following are specific details regarding the oral presentation:

Title: “Long-Term Follow-Up of a Phase 2 Clinical Trial to Induce Tolerance in Living Donor Renal Transplant Recipients”

Number: 463

Date: Saturday, May 30, 2020

Time: 3:15 p.m. ET

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients is now enrolling patients. More information about the FREEDOM-1 trial can be found at: https://freedom1study.com/

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

Talaris Therapeutics to Present at American Society of Hematology (ASH) Annual Meeting

BOSTON, Mass., and LOUISVILLE, Ky., Dec. 6, 2019 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, announced that founder Dr. Suzanne Ildstad will present a poster at the American Society of Hematology annual meeting, taking place December 7-10, 2019, in Orlando, Fla.

The presentation will address the potential of Talaris’ one-time cell therapy, FCR001, to induce immune tolerance in both matched related and unrelated recipients of living donor kidney transplants (LDKT). In Talaris’ Phase 2 trial of FCR001, 26 of 37 LDKT recipients were able to be weaned off all immunosuppressive treatments; subsequently, every tolerized patient has remained off all chronic immunosuppression, with median follow-up since transplant of approximately five years and longest follow-up of almost 10 years. The degree of HLA mismatch, spanning 0/6 to 6/6 between the donor and the recipient, did not affect either the safety or the efficacy of the therapy. Read the full abstract here.

The following are specific details regarding Talaris’ poster presentation:

Title:               Hematopoietic Mononuclear Cell Transplant with Minimal GVHD in up to Completely Mismatched Unrelated Recipients

Number:        3243

Session:        704. Immunotherapies: Poster II

Date:              Sunday, December 8, 2019

Time:              6:00 p.m. – 8:00 p.m. ET

Location:       Hall B, Orange County Convention Center, Orlando, Fla.

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients is now enrolling patients. More information about the FREEDOM-1 trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03995901

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

Talaris Therapeutics Presents Data Supporting Potential of FCR001 to Prevent Recurrence of Kidney-Related Autoimmune Disease in Kidney Transplant Recipients

BOSTON, Mass., and LOUISVILLE, Ky., Nov. 7, 2019 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today presented data demonstrating the potential of its cell therapy to resolve certain auto-immune diseases of the kidney.

The data, presented in a late-breaking poster at the 2019 American Society of Nephrology (ASN) Kidney Week conference, reflect an analysis of living donor kidney transplant recipients with auto-immune diseases of the kidney who underwent kidney transplant and treatment with Talaris’ cell therapy, FCR001, in the company’s Phase 2 trial.

Various auto-immune diseases — including IgA nephropathy, focal segmental glomerulosclerosis (FSGS) and membranous glomerulonephritis — degrade kidney function and can necessitate a kidney transplant. These conditions recur in a high percentage of cases post-transplant, potentially leading to an accelerated decline of the transplanted kidney. Therefore, repeated kidney transplants are often necessary for patients with these diseases.

Twelve subjects in Talaris’ Phase 2 trial experienced kidney failure as a result of an auto-immune disease. Within this cohort, seven patients were successfully tolerized with FCR001, including two with FSGS, which is a particularly aggressive kidney-related auto-immune condition. None of the seven successfully tolerized patients has to date had a detectable recurrence of their underlying auto-immune disease. Of the five other patients who displayed either transient or no immune chimerism, recurrence of the prior auto-immune disease was observed in two cases.

“We’re very excited by this demonstration of the potential of FCR001 to durably reset the immune system and halt auto-immune disease in patients in our Phase 2 trial. Many auto-immune diseases of the kidney are not resolved by a conventional kidney transplant, and therefore patients may require multiple transplants over the course of their lives. We’re hopeful that our cell therapy could interrupt this cycle of repeat transplants,” said Chief Executive Officer Scott Requadt. “Talaris plans to build upon these promising findings in an upcoming Phase 2 trial, in which we will evaluate the potential of FCR001 to treat certain severe auto-immune or immune-mediated disorders.”

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients is now enrolling patients. More information about the FREEDOM-1 trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03995901

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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 autoimmune and immune-mediated disorders. Talaris operates its own cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

 

Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

Pivotal trial to evaluate the safety and efficacy of novel, investigational cell therapy intended to durably free living donor kidney transplant recipients from immunosuppression

BOSTON, Mass., and LOUISVILLE, Ky., Oct. 23, 2019 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced the initiation of FREEDOM-1, the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

FREEDOM-1 is an open-label, randomized clinical trial comparing FCR001 to a standard of care (tacrolimus and mycophenolate-based) regimen for LDKT recipients. The trial is expected to enroll 120 adult LDKT recipients at multiple sites across the U.S. Its primary endpoint is the proportion of LDKT recipients free from immunosuppression at 24 months post-transplant. The trial will also evaluate the safety of FCR001 donors in the trial. The trial has begun enrolling patients at its first clinical site, Northwestern Memorial Hospital, and additional trial sites will be announced in coming months.

“Living donor kidney transplants save lives. However, they have a downside: the lifelong regimen of immunosuppressive drugs that organ transplant recipients must take elevates their risks of hypertension, high cholesterol, type 2 diabetes, sleep and CNS disorders, infections and certain cancers. Moreover, immunosuppressive drugs are, themselves, toxic to the kidney, leading to declining kidney function over time. On average, a transplanted kidney only lasts between 12-15 years, and many kidney transplant recipients will require multiple transplants over their lifetime,” said Scott Requadt, Chief Executive Officer of Talaris. “In our Phase 2 clinical trial, FCR001 demonstrated the capability to durably free a high percentage of LDKT recipients from immunosuppression and improve their overall quality of life post-transplant, findings which we now hope to reproduce in a larger group of patients in this Phase 3 trial as we advance this potentially transformative therapy.”

In Talaris’ groundbreaking Phase 2 study of FCR001, 26 of 37 (70%) LDKT recipients of FCR001 were able to be weaned off all immunosuppression treatments, with 100% durability to date. These results were equally robust regardless of the degree of HLA mismatch (spanning 0/6 to 6/6) between the donor and the recipient. Additionally, a subset of seven patients with an underlying autoimmune kidney disease who were able to withdraw from immunosuppression therapy have had no sign of recurrence of that autoimmune disease.

“Transplant surgeons have for decades searched for a way to establish durable immune tolerance to a donated organ, due to the risks and lifestyle limitations imposed by immunosuppression therapy,” said Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine and a principal investigator for the Phase 2 and Phase 3 trials of FCR001. He also is the director of kidney transplantation at Northwestern Medicine. “FCR001 has shown great promise toward achieving this goal, with all tolerized patients in the Phase 2 study remaining off immunosuppression. It’s gratifying as a physician to be part of a clinical trial for a therapy that has the potential to change the landscape of living donor kidney transplants and, importantly, improve outcomes for patients.”

More information about the FREEDOM-1 trial can be found at:  https://www.clinicaltrials.gov/ct2/show/NCT03995901

 

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics 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. The lead indication for FCR001 is to induce durable immune tolerance in living donor kidney transplant recipients. FCR001has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Talaris Therapeutics

Talaris Therapeutics, Inc. 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 autoimmune and immune-mediated disorders. Talaris operates its own cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

 

 

 

Talaris Therapeutics to Present at 2019 Cell & Gene Meeting on the Mesa

BOSTON, Mass., and LOUISVILLE, Ky., Sept. 26, 2019 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, announced today that CEO Scott Requadt will present at the annual Cell & Gene Meeting on the Mesa to be held October 2-4 in Carlsbad, California.

Talaris is developing an investigational, allogeneic cell therapy to induce or restore patients’ immune tolerance by establishing a stable, chimeric immune system comprised of both donor and recipient cells. Phase 2 data have shown that this therapy can durably free a significant proportion of living donor kidney transplant recipients from all chronic immunosuppression by about 12 months after their transplant, without rejection of their transplanted organ.

The following are specific details regarding Talaris’ company presentation at the conference:

Event:         2019 Cell & Gene Meeting on the Mesa

Date:           Wednesday, October 2, 2019

Time:          4:15 p.m. PT / 7:15 p.m. ET

Location:     Cognate Bioservices Ballroom, Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011

A live video webcast of all company presentations will be available at: http://www.meetingonthemesa.com/webcast and will also be published on the conference website shortly after the event.

Talaris Therapeutics

Talaris Therapeutics, Inc. 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. www.TalarisTx.com.

Media Contact

Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783

Talaris Therapeutics Wins 2019 “Big Idea” Xconomy Award

BOSTON, Mass., and LOUISVILLE, Ky., September 18, 2019 – Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, has been named the “Big Idea” winner of the 2019 Xconomy Awards.

Continue reading “Talaris Therapeutics Wins 2019 “Big Idea” Xconomy Award”