SAR441236 / Sanofi, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

A First-in-Human Study of the Trispecific HIV-1 Broadly Neutralizing Antibody, SAR441236 (CROI 2024) - "Background: The trispecific broadly neutralizing antibody (bNAb) SAR441236 combines the HIV-1 specificities of VRC01 (CD4 binding site), PGDM1400 (V1/V2 glycan binding), and 10E8v4 (membrane proximal external region) into one molecule with amino acid modifications (LS) in the Fc-region for half-life extension. SAR441236 administration was safe and well tolerated. The PK of SAR441236 was similar to traditional HIV-1 IgG antibodies with half-life extension modifications, such as VRC07-523LS. The favorable PK and convenience of administering a single biologic with three binding specificities support the evaluation of novel trispecific or multispecific bnAbs for HIV-1 treatment or prevention."

P1 data • Trispecific • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetics and Safety of SAR441236 (clinicaltrials.gov) - P1 | N=52 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | There had been no enrollment since October 2021, and by 2023, the available study product had reached its expiration date. Enrollment targets in Arm B had not been met.

Trial termination • Trispecific • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=84 ➔ 52

Enrollment change • Enrollment closed • Trispecific • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Nov 2022 ➔ Nov 2023 | Trial primary completion date: Nov 2022 ➔ Nov 2023

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Feb 2022 ➔ Nov 2022; Trial primary completion date: Feb 2022 ➔ Nov 2022

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

"Global T-cell Surface Glycoprotein CD4 Pipeline Insights 2020: CEL-1000, Forigerimod Acetate, Ibalizumab, M-48U1, MAX-16H5, SAR-441236, TMB-360, TMB-365, & Tregalizumab - https://t.co/guyiBzPH8C https://t.co/HcqgWElC5t" (@NewsFromBW)

Clinical • CD4

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1; N=84; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Jun 2021 ➔ Feb 2022; Trial primary completion date: Jun 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1; N=84; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); N=60 ➔ 84

Enrollment change • Gene Therapies • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics of SAR441236 (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting

Enrollment closed