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• Study delivers first clinical safety and pharmacokinetic data as proof of concept for the use of multispecific antibodies in humans
• Candidate showed similar half-life to standard monoclonal antibodies and minimal anti-drug antibodies
WESTON, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ:OPK), today announced results from a Phase 1 clinical study of SAR441236, its trispecific broadly neutralizing antibody against the human immunodeficiency virus (HIV), at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado. These clinical data are the first reported for a trispecific antibody and specifically provide support for the further development of multispecific, multivalent antibodies against HIV as a differentiated approach to addressing HIV infection.
The study enrolled 52 participants and was conducted by the AIDS Clinical Trials Group (ACTG), a clinical trials network funded by the National Institute of Allergy and Infectious Diseases, NIH. The observed antibody half-life was 38 ± 10 days. The antibody was safe and well-tolerated at all dose levels and via both intravenous and subcutaneous administration. Dosing ranged from 0.3 mg/kg to 30 mg/kg with up to 4 administrations, and observed pharmacokinetics remained consistent in all dosing regimens.
Broadly neutralizing antibodies such as SAR441236 are of interest for their novel mechanisms that may offer longer-lasting treatment and prevention to a wide range of HIV strains as the virus continues to evolve. Their complex interactions with other components of the immune system may also offer opportunities for long-term remission of HIV infection.
"This study represents a milestone in the development of multispecific antibodies, demonstrating key parameters of pharmacokinetics and safety. The study's full data set inform our ongoing development of multispecific antibodies to prevent or treat HIV infection," said Dr. John Mascola, Chief Scientific Officer of ModeX. "Existing oral antiretroviral therapies are a powerful tool in the fight against HIV, but multispecific antibodies offer long-lasting preventative and treatment options against a broad swathe of variants, with the possibility of activating the immune system against the latent virus population to effect a functional cure."
The development of SAR441235 is a result of a collaboration between ModeX and the Vaccine Research Center of the National Institute of Allergy and Infectious Disease, NIH. SAR441236 binds to three parts of HIV simultaneously and is engineered with amino acid modifications in its Fc-region for half-life extension. In preclinical studies, the candidate provided protection against multiple strains of simian HIV in vivo and showed broad neutralizing activity against a wide range of viral strains in vitro. Further analyses from the clinical study are ongoing, including analyses of antiviral efficacy in viremic participants and effects on the HIV-1 reservoir (infected cells that do not actively produce virus) in aviremic participants. These clinical data on an HIV multispecific antibody inform the future advancement of such antibodies for the prevention and treatment of HIV and provide strong rationale for the development of current and future antibody products.
Posted In: OPK
