Tonix Pharmaceuticals announced a partnership with Massachusetts General Hospital to conduct an investigator‑initiated, open‑label Phase 2 study of its dimeric Fc‑modified anti‑CD40L monoclonal antibody, TNX‑1500, in kidney transplant recipients.
The study will enroll five adult kidney transplant patients at MGH and will evaluate safety, tolerability, and activity of TNX‑1500 when combined with standard induction therapy (anti‑thymocyte globulin, tacrolimus, and corticosteroids). Corticosteroids will be tapered and discontinued by Day 33, while TNX‑1500 will be continued for 12 months. Tacrolimus will remain at a standard dose for six months, then be reduced to a low dose and discontinued after 12 months. The primary endpoint is the incidence of adverse and serious adverse events at 12 months, with secondary endpoints including graft survival, renal function, biopsy‑proven acute rejection, and donor‑specific antibody development.
The collaboration follows completion of a first‑in‑human Phase 1 pharmacodynamic and pharmacokinetic study of TNX‑1500, whose topline results were reported in the first quarter of 2025. The Phase 1 data demonstrated safety, tolerability, and a pharmacokinetic profile that supports monthly dosing.
The Phase 2 trial is scheduled to begin in the first half of 2026, pending institutional review board approval and FDA investigational new drug clearance. The study will provide early evidence on whether TNX‑1500 can reduce calcineurin‑inhibitor exposure and improve long‑term outcomes for kidney transplant recipients, potentially opening a new therapeutic pathway in transplant immunology.
Tonix’s financial position supports the expansion of its pipeline. The company reported a net loss of $22.11 million for Q4 2024, compared with a $27.32 million loss a year earlier, and a full‑year net loss of $130.04 million for 2024 versus $116.66 million in 2023. As of March 31 2025, Tonix held $131.7 million in cash, sufficient to fund operations into Q2 2026.
The anti‑CD40L antibody platform has a history of efficacy but has faced safety challenges, notably thromboembolic events with first‑generation agents. TNX‑1500 is engineered to maintain potency while improving safety and reducing clotting risk. Other companies are also developing anti‑CD40L therapies for transplantation, making the market competitive. Massachusetts General Hospital’s reputation in transplantation research strengthens the partnership’s strategic value.
The collaboration underscores Tonix’s strategy to develop TNX‑1500 for both organ transplant rejection and autoimmune diseases, positioning the company to address unmet needs in transplant immunology and potentially reduce reliance on calcineurin inhibitors, which carry significant long‑term side effects.
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