Clinical TrialMay 27, 2026, 07:02 AM
Tonix Pharma TNX-1500 Phase 1 Data Published; Phase 2 Study H2 2026
AI Summary
Tonix Pharmaceuticals announced the publication of positive Phase 1 data for TNX-1500, an investigational anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The study in healthy adults showed TNX-1500 was generally well tolerated with a favorable safety profile and effectively suppressed T cell-dependent antibody responses, supporting monthly intravenous dosing. A Phase 2 investigator-initiated study for kidney transplant rejection prevention is expected to begin in the second half of 2026 at Massachusetts General Hospital, pending FDA IND clearance.
Key Highlights
- Tonix published positive Phase 1 data for TNX-1500 in Journal of Clinical Immunology.
- TNX-1500 showed favorable safety; no serious adverse events in 26 healthy adults.
- Suppressed primary and secondary T cell-dependent antibody responses.
- Mean terminal elimination half-lives of 37.8 and 33.8 days at 10 and 30 mg/kg doses.
- Reduced peak secondary response to KLH by ~70% at the 3 mg/kg dose.
- Phase 2 study in 5 kidney transplant recipients expected H2 2026, pending FDA IND clearance.
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