Drug name
Last update: Sep 2026CAP256V2LS (mAb)
Drug information
Not provided
CAP256V2LS; derived from CAP256-VRC26.25
Not applicable (investigational; no brand name assigned)
Biotherapeutic
bNAb targeting the V1/V2 apex (V2 glycan) of the HIV-1 envelope trimer
CAP256V2LS is a V1/V2 apex-directed broadly neutralising antibody derived from CAP256-VRC26.25, isolated from a woman with clade C HIV in the CAPRISA 002 acute infection cohort in South Africa, and engineered with the LS Fc modification. It is extremely potent against susceptible viruses: it neutralised 63% of a 208-virus multiclade panel with a median IC50 of 0.001 microgram/mL. It is the first bNAb from Africa to be tested in Africa, primarily for prevention in young women. CAPRISA 012B (first-in-human, HIV-negative women in Durban) tested IV 5 and 10 mg/kg and SC 5 to 20 mg/kg, alone and with VRC07-523LS co-mixed with recombinant human hyaluronidase.
Investigational
Investigational. South African Health Products Regulatory Authority (SAHPRA) oversight for CAPRISA 012 trials.
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Administration route
Subcutaneous, Intravenous
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
- Every 4 months
Dosage
Investigational: 5 to 20 mg/kg (IV/SC); 1,200 mg fixed SC; 600 mg SC maintenance (CAPRISA 012C part B).
20 mg/kg SC
No approved regimen. CAPRISA 012C part B: loading 1.2 g, then 600 mg SC every 6 months, with VRC07-523LS 1.2 g SC.
Weight-based 20 mg/kg and fixed 1,200 mg gave comparable modelled exposure.
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Drug structure
Scale-up and manufacturing prospects
Not provided
Not provided
Broadly Neutralising Monoclonal Antibody (LS Fc modification). Recombinant human IgG1. Process details not published.
Not provided
Excipients & delivery device(s)
No proprietary excipient used
SC co-formulation with recombinant human hyaluronidase, ENHANZE, in CAPRISA 012B
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL