Medeor Therapeutics Completes Enrollment and Transplantation for Pivotal Trial of MDR-101 Cell Therapy to Establish Tolerance in HLA-Matched Living Donor Kidney Transplants

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Medeor Therapeutics, Inc., a clinical-stage company dedicated to the development and commercialization of immunotherapies for transplantation, today announced it completed enrollment and kidney transplantation of all patients in its Phase 3 prospective, multicenter, randomized trial. Patients are being evaluated for the efficacy and safety of its drug candidate MDR-101 to establish immune tolerance that allows for the complete withdrawal of immunosuppressive drugs in human leukocyte antigen (HLA)-matched living donor kidney transplant recipients. Life threatening side effects of today’s standard immunosuppressive drugs include heart disease, diabetes, infection and cancer.

“Today’s news is a tremendous milestone not only for Medeor but for the entire transplant community. This is the first randomized, multi-center pivotal study designed specifically to stop the use of all immunosuppressive anti-rejection drugs post-transplant. This therapy can be a true gamechanger in our efforts to transform transplant outcomes and help patients live healthier lives,” said Dan Brennan, MD, Chief Medical Officer at Medeor Therapeutics. “We thank the clinical investigators, trial coordinators and of course, the patients for their participation and contribution to this study. In addition, the grant we received from the California Institute for Regenerative Medicine made this study possible and we thank them for their continued support.”

Currently, patients who receive an organ transplant are dependent upon a lifelong regimen of immunosuppressive drugs that are associated with a litany of side effects and toxicities, and limited efficacy which ultimately impact graft and patient survival such that 30% to 50% of all kidney transplants fail by 10 years. Medeor’s lead product candidate, MDR-101, is a single-dose cellular therapy derived from a living kidney donor’s blood. The therapy is designed to establish mixed chimerism - the co-existence of both recipient-derived and donor-derived blood and immune cells to allow HLA-matched living donor kidney transplant recipients to discontinue immunosuppressive drug use while preserving long-term kidney transplant function and survival.

Medeor and MDR-101 arose from more than 15 years of pioneering research at Stanford University, directed by Dr. Samuel Strober, to determine if there was a way to transplant lifesaving organs, such as kidneys, without having patients be tethered to a lifelong course of immunosuppressive anti-rejection drugs. The ongoing clinical study and post treatment monitoring at Stanford has showed that most HLA-matched kidney transplant recipients could be withdrawn from all immunosuppressive drugs, with up to 15 years of follow up.

Medeor Therapeutics will report interim results of its Phase 3 MERCURY tolerance study, a randomized, multi-center study evaluating the functional immune tolerance in MDR-101 recipients of HLA-matched living donor kidney transplants as compared to standard of care, at the ATC Virtual Congress on June 7, 2021. Medeor has additional pipeline research that will be initiated in the coming months. Details can be found at https://www.medeortx.com/our-pipeline/clinical-trials.php.

About MDR-101

MDR-101 is a single dose cellular therapy manufactured from a living kidney donor’s blood and peripheral stem cells. MDR-101 is intended to induce donor-specific immune tolerance in order to avert transplant kidney rejection to minimize the cumulative and serious side effects associated with immunosuppressive drugs and thereby preserve transplant kidney function and survival. For more information on Medeor’s Phase 3 trial, please visit https://clinicaltrials.gov.

About Medeor Therapeutics, Inc.

Medeor Therapeutics is working to improve the lives of transplant patients by eliminating or reducing the need for a life-long regimen of immunosuppressive medications and their potential life-threatening side effects. Medeor’s Phase 3 clinical study is demonstrating the significant opportunities of this one-time therapy. For more information, visit www.medeortx.com.