Phase 1 Results: ModeX's Trispecific Antibody for HIV Treatment and Prevention

A recent study has provided initial evidence supporting the use of multispecific antibodies in clinical settings, showcasing their safety and pharmacokinetics. The research focused on a trispecific antibody known as SAR441236, developed by ModeX Therapeutics Inc., a subsidiary of OPKO Health. This antibody is designed to neutralize the human immunodeficiency virus (HIV) and was tested in a Phase 1 clinical trial involving 52 participants.
The trial, conducted by the AIDS Clinical Trials Group (ACTG), found that the antibody had a half-life of approximately 38 days and was deemed safe and well-tolerated across all tested dosages and administration methods. The dosages ranged from 0.3 mg/kg to 30 mg/kg, with up to four administrations, and the pharmacokinetic profile was consistent across different dosing schedules.
The trispecific antibody, SAR441236, is of particular interest due to its potential to provide long-lasting treatments and prevention against a broad spectrum of HIV strains. It is engineered to bind to three distinct regions of HIV simultaneously and has undergone modifications to extend its half-life. Preclinical studies have demonstrated its ability to protect against multiple strains of simian HIV and to exhibit broad neutralizing activity against various HIV strains in vitro.
Dr. John Mascola, Chief Scientific Officer at ModeX, highlighted the study as a significant milestone, noting that it provides valuable pharmacokinetic and safety data for the ongoing development of multispecific antibodies. He emphasized the potential of these antibodies to offer long-term preventative and therapeutic options, possibly leading to a functional cure for HIV.
The development of SAR441236 is a collaborative effort between ModeX and the Vaccine Research Center of the National Institute of Allergy and Infectious Disease (NIAID), part of the NIH. Further analysis from the clinical trial is ongoing, focusing on the antibody's antiviral efficacy and its impact on the HIV-1 reservoir in participants.
ModeX Therapeutics is a clinical-stage biopharmaceutical company that specializes in the development of innovative multispecific biologics for cancer and infectious diseases. Their pipeline includes candidates for both solid tumors and hematologic cancers, as well as several viral threats. The company is based in Weston, Massachusetts, and is part of the OPKO Health group, which is a multinational biopharmaceutical and diagnostics company.

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