WESTON, Mass. - ModeX Therapeutics Inc., a subsidiary of OPKO Health (NASDAQ: OPK), announced on Monday the results from a Phase 1 clinical study of SAR441236, its innovative trispecific antibody against HIV.
The study, presented at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, marks the first clinical safety and pharmacokinetic data for a trispecific antibody in humans.
The study, which enrolled 52 participants, was conducted by the AIDS Clinical Trials Group (ACTG), funded by the National Institute of Allergy and Infectious Diseases, NIH. It revealed that SAR441236 has a similar half-life to standard monoclonal antibodies, approximately 38 days, and induced minimal anti-drug antibodies. The antibody was safe and well-tolerated at all dose levels, administered both intravenously and subcutaneously.
SAR441236 is engineered to bind to three parts of the HIV virus simultaneously, with amino acid modifications in its Fc-region for half-life extension. This design could potentially offer longer-lasting treatment and prevention across a wide range of HIV strains.
Dr. John Mascola, Chief Scientific Officer of ModeX, highlighted the significance of the findings, stating that multispecific antibodies could provide long-lasting options against HIV variants and may activate the immune system against the latent virus to effect a functional cure.
The development of SAR441236 stems from a collaboration between ModeX and the Vaccine Research Center of the National Institute of Allergy and Infectious Disease, NIH. Preclinical studies have shown that the candidate can protect against multiple strains of simian HIV in vivo and exhibits broad neutralizing activity against a wide range of viral strains in vitro.
Further analysis of the clinical study is underway, including the evaluation of antiviral efficacy in viremic participants and effects on the HIV-1 reservoir in aviremic participants. These findings underpin the advancement of multispecific antibodies for the prevention and treatment of HIV, offering a strong rationale for the development of current and future antibody products.
ModeX Therapeutics, based in Weston, Massachusetts, is a clinical-stage biopharmaceutical company focusing on developing multispecific biologics for cancer and infectious diseases.
OPKO Health is a multinational biopharmaceutical and diagnostics company. The information reported is based on a press release statement.
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