GlobeNewswire·May 27, 2026, 7:00 AM ET

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

TNXP

Phase 1 data supports TNX-1500 as a potentially first-in-class & best-in-class third-generation anti-CD40L monoclonal antibody for preventing kidney transplant rejection.
Tonix Pharmaceuticals announced the publication of Phase 1 study results in the Journal of Clinical Immunology involving 26 healthy adult volunteers.
The Phase 1 study was a randomized, double-blind, placebo-controlled, single-ascending dose trial evaluating safety, tolerability, pharmacokinetics, & pharmacodynamics.
TNX-1500 demonstrated a favorable safety profile with no serious adverse events, no discontinuations due to adverse events, & only mild treatment-emergent adverse events (aphthous ulcers) in 3 participants.
The antibody suppressed primary & secondary T cell-dependent antibody responses to KLH antigen, blocked secondary responses at 10 & 30 mg/kg doses, & reduced peak secondary response by ~70% at the 3 mg/kg dose.
Pharmacokinetic analyses indicated dose-proportional exposure across 3 to 30 mg/kg doses with mean terminal elimination half-lives of 37.8 days (10 mg/kg) & 33.8 days (30 mg/kg), supporting monthly intravenous dosing.
TNX-1500 caused a rapid & sustained reduction in soluble CD40L levels over the 120-day study period.
An investigator-initiated Phase 2 study at Massachusetts General Hospital (MGH) is expected to initiate in the second half of 2026 pending FDA clearance of the Investigational New Drug application.
The Phase 2 study will evaluate TNX-1500 in five kidney transplant recipients to assess its ability to prevent rejection while reducing reliance on conventional immunosuppressive drugs.
Tonix is developing TNX-1500 for the prevention of organ transplant rejection & treatment of autoimmune diseases, with ongoing preclinical collaborations on allo-heart & kidney transplantation.