Clinical TrialMay 27, 2026, 07:16 AM
Tonix Pharma Publishes Positive Phase 1 TNX-1500 Data; Phase 2 H2 2026
AI Summary
Tonix Pharmaceuticals announced the publication of positive Phase 1 clinical data for TNX-1500, an Fc-modified anti-CD154 monoclonal antibody, in the Journal of Clinical Immunology. The study in 26 healthy adults showed TNX-1500 was well-tolerated and effectively blocked T cell-dependent antibody responses, supporting its development for organ transplant rejection and autoimmune diseases. A Phase 2 investigator-initiated study for kidney transplant rejection is expected to begin in the second half of 2026, pending FDA IND clearance.
Key Highlights
- Phase 1 data for TNX-1500, an anti-CD154 mAb, published in Journal of Clinical Immunology.
- TNX-1500 blocked primary T cell-dependent antibody response (TDAR) at all doses.
- Blocked secondary TDAR at 10 and 30 mg/kg doses, reducing peak response by ~70% at 3 mg/kg.
- Generally well tolerated with no serious adverse events or discontinuations.
- Mean terminal elimination half-lives of 33.8-37.8 days support monthly intravenous dosing.
- Phase 2 investigator-initiated study in kidney transplant expected to start H2 2026.
- Phase 2 study pending FDA clearance of MGH's Investigational New Drug (IND) application.
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