MIC-Lx / TolerogenixX - LARVOL DELTA

TolerogenixX Has Received EMA Orphan Drug Designation for MIC-Lx, Strengthening its Regulatory Pathway in Kidney Transplantation (The Manila Times)

Orphan drug • Renal Disease • Transplantation

EMA Grants PRIME Designation to TolerogenixX’s MIC-Lx Therapy for Donor-Specific Immune Tolerance in Kidney Transplantation (GlobeNewswire) - "The PRIME designation follows a positive assessment by the Committee for Advanced Therapies (CAT) and endorsement by the Committee for Medicinal Products for Human Use (CHMP) during its February 2026 meeting....Clinical Phase I and ongoing Phase II studies in renal transplant patients with follow-up data of up to 10 years support the proposed mechanism of action and indicate: absence of donor-specific antibody responses; substantial reduction of immunosuppressive therapy; fewer opportunistic infections....The Company plans to publish data from an ongoing Phase IIb trial in the first half of 2027."

European regulatory • P2b data • Transplantation

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Trial completion date: Jun 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Transplantation

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Trial completion date: May 2026 ➔ Jun 2027 | Trial primary completion date: May 2024 ➔ Jun 2025

Immune cell • Trial completion date • Trial primary completion date • Transplantation

Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation. (PubMed, Front Immunol) - P1 | "The administration of modified immune cells (MIC) before kidney transplantation led to specific immunosuppression against the allogeneic donor and a significant increase in regulatory B lymphocytes...https://clinicaltrials.gov/, identifier NCT02560220 (for the TOL-1 Study). EudraCT Number: 2014-002086-30."

Immune cell • Journal • P1 data • Retrospective data • Infectious Disease • Transplant Rejection • Transplantation • CD27

Modified Immune Cell (MIC) Therapy disrupts Tertiary Lymphoid Structures in Murine Lupus Nephritis (P762) (IMMUNOLOGY 2023) - "Induction of tolerance can be achieved with Modified Immune Cells (MIC) by infusion of mononuclear cells challenged with mitomycin C (MMC). However, regulatory T-cells remained unchanged indicative of a B-cell centric treatment mechanism. Our data provides a putative in vivo mechanism how MIC treatment inhibits progression of active lupus nephritis by the destruction of tertiary lymphoid structures within the kidney."

Immune cell • Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Solid Organ Transplantation • Transplantation

Individualised immunosuppression with intravenously administered donor-derived modified immune cells compared with standard of care in living donor kidney transplantation (TOL-2 Study): protocol for a multicentre, open-label, phase II, randomised controlled trial. (PubMed, BMJ Open) - P2 | "Donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation...The results from the TOL-2 Study will be published in peer-reviewed medical journals and will be presented at symposia and scientific meetings. NCT05365672."

Clinical protocol • Journal • P2 data • Immunology • Infectious Disease • Nephrology • Transplant Rejection • Transplantation

Modified Immune Cell (MIC) Therapy Disrupts Tertiary Lymphoid Structures in Murine Lupus Nephritis (KIDNEY WEEK 2022) - "Funding Commercial Support Background Induction of tolerance can be achieved with Modified Immune Cells (MIC) by infusion of mononuclear cells challenged with mitomycin C (MMC). However, regulatory T-cells remained unchanged indicative of a B-cell centric treatment mechanism. Conclusion Our data provides a putative in vivo mechanism how MIC treatment inhibits progression of active lupus nephritis by the destruction of tertiary lymphoid structures within the kidney."

Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Solid Organ Transplantation • Transplantation

Induction of Long-lasting Regulatory B Lymphocytes by Modified Immune Cells in Kidney Transplant Recipients. (PubMed, J Am Soc Nephrol) - "Conclusions These results indicate that donor-specific immunosuppression after MIC infusion is long-lasting and associated with a striking increase in regulatory B lymphocytes. Donor-derived MICs appear to be an immunoregulatory cell population which, when administered to recipients prior to transplantation, may exert a beneficial effect on kidney transplants."

Journal • Transplant Rejection • Transplantation

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: TolerogenixX GmbH

New P2 trial • Transplantation

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation