News

Talaris Therapeutics Appoints Mary Kay Fenton as Chief Financial Officer

BOSTON, Mass., and LOUISVILLE, Ky., March 4, 2021 – Talaris Therapeutics, Inc., a late- clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune or metabolic disorders, today announced the appointment of Mary Kay Fenton as Chief Financial Officer.

“Mary Kay is an important addition to Talaris’ executive team. She brings great leadership and strategic skills, strong financial acumen and a deep understanding of the cell therapy space. She has successfully led a number of companies in our industry through a wide range of important financial and operational milestones. Her appointment rounds out Talaris’ experienced leadership team and sets us up well for continued success,” said Scott Requadt, Chief Executive Officer of Talaris. “I look forward to working closely with Mary Kay to continue to advance Talaris’ exciting pipeline of innovative cell therapies and build out our in-house cell processing capabilities over the coming years.”

Ms. Fenton has over 25 years of operational and transactional experience in the biotechnology industry. Prior to joining Talaris, Ms. Fenton served as Vice President, Strategic Operations for the Cell and Genetic Therapies unit at Vertex Pharmaceuticals. Before that role, she was the Chief Financial Officer and Chief Operating Officer of Semma Therapeutics, which was developing a novel cell therapy for type-1 diabetes until it was acquired by Vertex. Ms. Fenton joined Semma Therapeutics from Achillion Pharmaceuticals, where she served as Chief Financial Officer from 2006 to 2018. At Achillion, Ms. Fenton was a key member of the executive team and played an instrumental role in the company’s growth, including overseeing multiple public and private capital raises and leading financial and operational functions. Before joining Achillion, Ms. Fenton held various positions within the Technology Industry Group at PricewaterhouseCoopers LLP, an independent registered public accounting firm.

Ms. Fenton currently serves as Audit Committee Chair on the Board of Directors at Oncorus Inc., a public company developing novel viral immunotherapies for cancer. She holds an MBA in finance from the Graduate School of Business at the University of Connecticut and a A.B. in economics from the College of the Holy Cross.

About Talaris Therapeutics

Talaris Therapeutics, Inc. is a late- clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune or metabolic 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 Appoints Four Vice Presidents in Areas of Strategic Importance

BOSTON, Mass., and LOUISVILLE, Ky., February 25, 2021 – Talaris Therapeutics, Inc., a late-clinical stage cell therapy company developing an innovative method of allogeneic hematopoietic stem cell transplantation with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune, or metabolic disorders, today announced the appointment of four vice presidents in areas of strategic importance for the company.

Devin Blass, Vice President of Technical Operations, previously served as Senior Director of Manufacturing and Supply Chain at Talaris. Before joining the company in 2019, Mr. Blass oversaw cell manufacturing operations at Bellicum Pharmaceuticals and was the Director, Commercial Program Manufacturing at Mesoblast. Prior to his industry experience, Mr. Blass advanced through roles of increasing responsibility at MD Anderson Cancer Center, where he played a significant role in building the infrastructure and systems to obtain licensure for HPC, Cord Blood. He holds a B.S. in biochemistry from Texas State University.

Eric Gornstein, Vice President of Strategy, previously served as Head of New Product Planning at Talaris. Mr. Gornstein joined Talaris in 2019 from Radius Health, where he led the company’s commercial insights and analytics function and helped build the commercial operations organization and infrastructure to launch their first product, Tymlos®, in the United States. Previously, he served in market and business development roles at Biogen, Millennium, TransForm, Acceleron and AstraZeneca, and as a strategy consulting Director at Leerink Swann Consulting and Navigant. Mr. Gornstein holds a B.A. with distinction in biology from Boston University, where he was a Trustee Scholar, and an MBA from MIT Sloan School of Management.

Kirstin Powel, Vice President of Quality Assurance, comes to Talaris from the Novartis Cell and Gene Therapy Unit where she served as Global Head of Quality Operations. In that role she had quality responsibility for the overall supply chain and played a key role in pre-approval inspection preparation and global launch processes for the first FDA-approved CAR-T cell therapy, Kymriah. Ms. Powel was previously employed by Lonza, AG in positions with increasing levels of responsibility in Quality, most recently in the Global Quality organization with global quality oversight for biologics as well as cell and gene therapy products. Ms. Powel holds a B.A. in biochemistry from Rutgers University and an M.S. in physiology from North Carolina State University.

 

Suzanne Tollerud, Vice President of Corporate Development, previously served as Vice President of Operations at Talaris. Prior to joining the company in 2014 as its Director of Business Operations, Ms. Tollerud worked in management consulting at The Bridgespan Group and Bain & Co. in roles of increasing responsibility. She holds an M.A. in sociology and a B.A. in East Asian studies, both from Stanford University.

“We’re delighted to welcome these four individuals to their new roles in areas of great importance for Talaris moving forward, as we build out our in-house manufacturing and quality operations, advance our lead program through a Phase 3 registration clinical trial, and expand our therapeutic pipeline,” said Scott Requadt, Chief Executive Officer of Talaris. “We look forward to their continued contributions to Talaris’ success.”

About Talaris Therapeutics

Talaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing an innovative method of allogeneic hematopoietic stem cell transplantation with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune, or metabolic disorders. Talaris is backed by a number of leading life sciences investors and maintains corporate offices in Boston, Mass., and a cell processing facility in Louisville, Ky. www.TalarisTx.com.

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

Talaris Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

BOSTON, Mass., and LOUISVILLE, Ky., January 8, 2021 – 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, is scheduled to virtually present at the 39th Annual J.P. Morgan Healthcare Conference. Chief Executive Officer Scott Requadt will present a company overview on Monday, January 11, 2021 at 9:15 a.m. ET.

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 Expands Leadership Team with Appointments of Accomplished Executives in Manufacturing, Portfolio Strategy and Clinical Operations

BOSTON, Mass., and LOUISVILLE, Ky., November 12, 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 the expansion of its senior leadership team with the appointments of Michael Zdanowski as Chief Technology Officer, Farah Natoli as Head of Portfolio and Program Management and Mary West as Vice President, Clinical Operations.

“The appointments of Michael, Farah and Mary build on our recently announced Series B financing to position Talaris for long-term success, as we advance our ongoing Phase 3 trial in living donor kidney transplant, prepare for additional Phase 2 trials next year and further realize the ‘pipeline in a product’ potential of our unique cell therapy. Their accomplished and diverse backgrounds in manufacturing, portfolio strategy and clinical operations will be key assets guiding our future strategic direction,” said Scott Requadt, Chief Executive Officer of Talaris. “We are excited to welcome them to the Talaris team and look forward to their important contributions to Talaris’ continued success.”

Mr. Zdanowski, Chief Technology Officer, is an accomplished leader in cell therapy manufacturing with over 25 years of experience. He has led manufacturing, logistics, quality and analytical development groups for stem cell organizations, and led design, construction and validation of facilities for commercial manufacturing for such firms as Pfizer Pharmaceuticals, Bayer Pharmaceuticals and Regeneron Pharmaceuticals. He was most recently Senior Vice President of BioPharmaceutical Operations for Medeor Therapeutics. Previously, Mr. Zdanowski was Vice President of GMP Operations for the New York Stem Cell Foundation and Vice President of Manufacturing for Mesoblast. Mr. Zdanowski has prepared FDA & EU CMC submissions for several late-stage stem cell products, including the BLA supporting FDA approval for the first allogeneic stem cell therapy product, HemaCord®. He received his MBA from Columbia University and degrees in mechanical engineering and philosophy from the University of Pennsylvania.

Ms. Natoli, Head of Portfolio and Program Management, brings deep expertise in strategic direction and operational oversight of program advancement. She served most recently as Vice President, Program Management at Imara, in which capacity she provided strategic and operational leadership for Imara’s global programs in sickle cell anemia and beta-thalassemia. Previously, Ms. Natoli served as the Executive Director, Program and Alliance Leadership at Bioverativ, a Sanofi Company; prior to that she held roles at AMAG Pharmaceuticals and FORUM Pharmaceuticals. Ms. Natoli holds an M.S. in natural sciences from the Roswell Park Cancer Institute, a division of State University of New York at Buffalo, and graduated with a B.S. in biology-chemistry and medical technology from Elmira College.

Ms. West, Vice President, Clinical Operations, brings an extensive background in complex clinical trial execution and team leadership. Most notably, she led all clinical operations at Boston-based Alnylam Pharmaceuticals for their lead product, Onpattro®, in a successful registration trial that recruited over 220 patients globally and led to the historic approval of the product in late 2018. Ms. West previously served in clinical operations leadership roles at Paratek Pharmaceuticals, Momenta Pharmaceuticals, Acambis Pharmaceuticals, Millennium Pharmaceuticals and Pfizer Pharmaceuticals. Until recently, she was Head of Clinical Operations at BlueRock Therapeutics, where she implemented all of their GCP quality systems and laid the operational groundwork for their first IND. Ms. West received her M.S. in project management from Boston University and her B.S. in dietetics from Michigan State University.

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 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