MDR-101 / Medeor Therap - LARVOL DELTA

Induction of Immune Tolerance in Living Related HLA-Matched Kidney Transplantation: A Phase 3 Randomized Clinical Trial. (PubMed, Am J Transplant) - P3 | "Treatment recipients received a non-myeloablative conditioning protocol with rabbit antithymocyte globulin and low-dose total lymphoid irradiation (10 fractions). Kidney transplant recipients receiving MDR-101 achieved donor mixed chimerism and functional immune tolerance for greater than two years with no death, graft loss, DSA or GVHD and demonstrated improved quality of life compared to standard treatment. Clinical Trial Registration - NCT03363945 (not part of word count)."

Clinical • Journal • P3 data • Glomerulonephritis • Graft versus Host Disease • IgA Nephropathy • Immunology • Transplantation • ABCB1

Immune Tolerance With MDR-101 in Transplant Recipients (DocWire) - P3 | N=30 | NCT03363945 | Sponsor: Medeor Therapeutics, Inc. | "Participants comprised adult recipients of a first kidney from an HLA-matched related LD who were randomized 2:1 to a treatment arm (TA, n=20) or control arm (CA, n=10). Patients in the CA arm received IS per standard of care. Patients in the TA arm were transplanted at day (D) 0 and received (rabbit) antithymocyte globulin D0-4 and low-dose total lymphoid irradiation to induce chimerism after MDR-101 infusion on D11. IS was given throughout 1 year and then discontinued. Steroids were withdrawn by D10, and mycophenolate mofetil was given D11-D39. Tacrolimus began on D11, and monotherapy continued from D40 until D180 and then gradually was withdrawn 1 year after transplant if mixed chimerism was ≥5% and there was no biopsy-proven acute rejection, graft-versus-host disease (GVHD), or kidney loss."

P3 data • Transplant Rejection

Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants (clinicaltrials.gov) - P3 | N=30 | Completed | Sponsor: Medeor Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Apr 2024 | Trial primary completion date: Sep 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Immunology • Transplant Rejection • Transplantation

MDR-101-MLK- Operational Immune Tolerance Achieved in Living Related HLA-Matched Kidney Transplant Recipients (ATC 2024) - "MDR-101 safely achieved donor mixed chimerism and functional immune tolerance with complete elimination of all IS with no death, graft loss, or GVHD in HLA-matched LD kidney transplant recipients with improved quality of life. The FDA-agreed treatment success of at least 48% IS-free for at least 24-month was exceeded."

Clinical • Late-breaking abstract • Glomerulonephritis • Graft versus Host Disease • IgA Nephropathy • Immunology • Nephrology • Oncology • Transplantation • ABCB1 • CD34

Medeor's Cell Therapy MDR-101 Allows Patients to Taper off Immunosuppression Following Kidney Transplant (CGTLive) - "'The results from this study are extremely promising,' Dixon Kaufman...added to the statement. 'This innovative trial provides direction toward reducing the need for life-long antirejection medications in transplant recipients. With the achievement of mixed chimerism in this trial, we are on course to provide a safer and more effective treatment approach for many patients in need of a kidney transplant.'"

Media quote

MDR-101-MLK Update: Operational Immune Tolerance Achieved in Living Related HLA-Matched Kidney Transplant Recipients (KIDNEY WEEK 2023) - P3 | "MDR-101 can safely achieve donor mixed chimerism and operational immune tolerance with complete elimination of all IS with no death, graft loss, or GvHD in HLA-matched LD recipients. The protocol anticipated treatment success of at least 48% IA-R IS-Free for at least 24 mos was met."

Clinical • Glomerulonephritis • Graft versus Host Disease • IgA Nephropathy • Immunology • Oncology • Transplantation • ABCB1 • CD34

Medeor Therapeutics Announces Interim Data from Pivotal Trial Showing Cell Therapy Technology Could Eliminate Life-Long Need for Immunosuppressant Drugs Following Kidney Transplant (Businesswire) - P3 | N=30 | NCT03363945 | Sponsor: Medeor Therapeutics, Inc. | "Results shared in late-breaking oral presentation at ASN Kidney Week 2023....Medeor Therapeutics today announced positive interim data from its multicenter, international Phase III clinical trial. Kidney transplant recipients who received a living donor kidney from an HLA-matched relative achieved functional tolerance and were free from the regimen of immunosuppressive drugs. Typically, these drugs are required to prevent rejection and failure of the kidney transplant....Twenty patients received MDR-101 and were compared to 10 similar patients who had standard of care. Results include: The study’s primary efficacy endpoint was met and exceeded. To date, 12 patients, or 63% of the study participants (compared to the protocol anticipated success rate of 48%), completed the trial and have been off immunosuppression therapy for two years."

Late-breaking abstract • P3 data • Transplant Rejection