Drug intelligence / Profile preview

COMBI 1

Development stage: Unknown
Lead developer: Vaccine Research Institute
Modality: DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Intramuscular

Overview

COMBI 1 is a combination HIV vaccine regimen evaluated in the ANRS VRI06 Phase I clinical trial. It consists of the co-administration of CD40.HIVRI.Env, a biological vaccine comprising an anti-CD40 monoclonal antibody fused to the HIV-1 envelope glycoprotein gp140 (Clade C, strain 96ZM651), adjuvanted with the Toll-like receptor 3 (TLR3) agonist Poly-ICLC (Hiltonol), and the DNA-HIV-PT123 vaccine, which encodes multiple HIV antigens including gp140, Gag, Pol, and Nef. Developed by ANRS Emerging Infectious Diseases and the Vaccine Research Institute (VRI), the regimen aims to target dendritic cells via the CD40 receptor to enhance antigen presentation and elicit robust humoral and cellular immune responses. Phase I results (NCT04842682) indicated that the combination is safe and induces early, sustained anti-Env cellular and V1V2 IgG responses in healthy HIV-negative volunteers.

Other names: CD40.HIVRI.Env + DNA-HIV-PT123 + Poly-ICLCCD40.HIVRI.Env + DNA-HIV-PT123 + Hiltonol

Targets

Env (HIV-1 envelope glycoprotein)CD40 (Cluster of differentiation 40 receptor)TLR3 (Toll-like receptor 3)

Beyond the preview

Go deeper on COMBI 1.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

Trial phase
Status
Readouts

Indications & development

Explore development by indication, patient population, and geography.

Indications
Development status
Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

Partners
Deal terms
Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

Patents
Expiration dates
Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

Competing assets
Targets
Development stage

Research & analysis

Connect source evidence and development news to your research questions.

Publications
News
Analysis

Bring the full picture into focus.

See how Gosset can support your research on COMBI 1.

Explore the full profile