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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”

Talaris Therapeutics Presents Data Demonstrating Improved Quality of Life for Patients Treated with FCR001

BOSTON, Mass., and LOUISVILLE, Ky., June 2, 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, is presenting today new data from its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) recipients in a poster at the 2019 American Transplant Congress in Boston. These data indicate that the induction of tolerance achieved with FCR001 was associated with significantly improved quality of life measures for transplant recipients.

FCR001 is an investigational, allogeneic cell therapy that is being developed 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 shownthat FCR001 can durably free a significant proportion of LDKT recipients from all chronic immunosuppression by about 12 months after their transplant, without rejection of their transplanted organ.

The recently completed quality of life study compared 13 patients in the Phase 2 trial to 12 patients who would have met the Phase 2 trial inclusion criteria but were transplanted under standard of care therapy. Patients were administered three validated quality of life questionnaires. Compared to those receiving standard of care, patients tolerized with FCR001 reported superior quality of life in the form of lower levels of psychological stress, anxiety and depression, and increased overall mental health. They also reported lower levels of pain and greater overall health. The poster, entitled “Quality of Life in Tolerant Living Donor Kidney Transplants vs. Standard of Care,” is on display on Sunday, June 2, from 6:00-7:00pm (board #251).

“These data complement the safety and efficacy of FCR001 observed in our Phase 2 trial,” said Chief Executive Officer Scott Requadt. “The negative impacts of chronic immunosuppression following a life-saving transplant, such as the high pill burden, lifestyle constraints and psychological stress, represent serious, daily and often underappreciated challenges for the vast majority of transplant recipients. It’s not surprising that inducing durable immune tolerance to a donated organ can not only result in improved long-term health for LDKT recipients — including better kidney function and lower cardiovascular risk — but can also potentially lead to a significantly better quality of life. At Talaris we are working to enable patients to live their fullest lives post-transplant.”

Talaris also presented at the 2019 American Transplant Congress two posters containing preclinical data on its Facilitating Cell platform:

  • “JAK Inhibitor as a Novel Conditioning Approach to Establish Mixed Chimerism and Prevent Type 1 Diabetes Non-myeloablatively”: Saturday, June 1, 2019, 5:30-7:30pm, Board #43
  • “Prevention of Diabetes in the NOD Mice Reconstituted with Bone Marrow Cells from Allogeneic CD4 Knockout, CD8 Knockout or B-Cell Knockout B6 Mice”: Tuesday, June 4, 2019, 6:00-7:00pm, Board #61

Finally, in an oral presentation entitled “Ten Year Follow-Up of a Phase 2 Clinical Trial to Induce Tolerance in Living Donor Renal Transplant Recipients,” the company will share longer term follow up data from the Phase 2 trial of FCR001. The presentation is Tuesday, June 4, 2019 at 4:30pm at the John B. Hynes Convention Center Veterans Auditorium (Publication #522).

About FCR001

FCR001 is an investigational, allogeneic cell therapy being developed by Talaris to induce durable immune tolerance in patients who receive a transplanted organ or to restore tolerance to self in patients with certain severe auto-immune or immune-mediated disorders. Talaris is initiating in 2019 a pivotal study of FCR001 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., 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. www.TalarisTx.com.

Media Contact

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

 

 

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Talaris Therapeutics, Inc. Announces $100M Series A Financing to Advance Its Novel, Allogeneic Cell Therapy Through Late-Stage Clinical Development

  • Financing will support Phase 3 trial of FCR001 for living donor kidney transplant patients and additional Phase 2 studies in high-need indications
  • Formerly Regenerex, the company’s new name reflects its patient- and impact-driven mission of inducing and restoring immune tolerance
  • Names Scott Requadt Chief Executive Officer and additional members of leadership team and Board of Directors

BOSTON, Mass., and LOUISVILLE, Ky., April 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, today announced the closing of a $100 million Series A financing. 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 (LDKT) recipients, as well as additional Phase 2 studies in other high-need indications, following the company’s promising Phase 2 data also announced today (link here to other release). In the Phase 2 trial, 70 percent 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.

“Talaris’ cell therapy technology has great promise for post-transplant care, with the potential to replace lifelong immunosuppressants with a single, durable treatment,” said Nicholas Galakatos, Head of Blackstone Life Sciences. “Talaris’ focus on disease modifying therapies, its readiness to initiate a pivotal study executed by an experienced management team, and the product’s potential to improve the lives of many patients, all align well with the Blackstone Life Sciences investment strategy.”

Mr. 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 & Johnson.  He started his career as a mergers & acquisitions lawyer at Davis Polk & Wardwell.

“Inducing durable, drug-free immune tolerance to a transplanted organ has been a long-standing aspiration in the transplant field,” said CEO Scott Requadt.  “With this substantial financing, Talaris is well positioned to rapidly advance this important therapy into a registration study for LDKT and through additional proof-of-concept clinical trials. The opportunity to change the course of the post-transplant outlook for patients is tremendously exciting, and I am thrilled to join Talaris at this pivotal time in the company’s journey toward this goal.”

The company also today announced the founding Board of Directors of Talaris, 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.

Dr. Ildstad, a transplant surgeon by training, developed the FCR001 platform while at the Institute for Cellular Therapeutics at the University of Louisville. She has devoted over 30 years of her career to researching and developing approaches to induce immune tolerance in organ transplant recipients and to enable safer allogeneic stem cell transplant procedures between mismatched donor-recipient pairs.

“Safely and reproducibly inducing or restoring immune tolerance via a one-time administration of FCR001 could eventually become a new standard of care both in organ transplant and in certain types of severe auto-immune or immune-mediated disorders,” said Dr. Francois Nader, Chairman of Talaris. “This financing will enable the company to explore the therapy’s potential to benefit patients across a number of areas of significant unmet medical need.”

Talaris has also added four key members to its senior leadership team:

  • 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 Corporation. 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.

About FCR001

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. 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., 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. www.TalarisTx.com.

 

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