Drug name
Last update: Oct 2026VRC01.23LS (mAb)
Developer(s)
Drug information
Not provided
VRC01.23LS
investigational
Biotherapeutic
mAb (Monoclonal antibody) — bNAb targeting the CD4 binding site of HIV-1 envelope gp120. Second-generation VRC01-class antibody with LS half-life extension.
Dormant / No Development Reported — Clinical trial material was reported available at 100 mg/mL in 2023 and a first-in-human trial was described as underway, with HVTN 143/HPTN 109 as the designated protocol (version 1.0 dated 7 June 2023).
VRC01.23LS is a second-generation VRC01-class broadly neutralising antibody targeting the CD4 binding site of the HIV-1 envelope glycoprotein gp120, carrying the LS Fc modification for half-life extension. It sits in IAVI's engineered bNAb (ebnAb) portfolio as the CD4bs component, alongside the V3-glycan antibody ePGT121v1-LS and a V2-apex antibody. IAVI portfolio material from October 2023 reported that VRC01.23LS had been manufactured, that a first-in-human trial was underway, and that clinical trial material was available at 100 mg/mL for HVTN 143/HPTN 109. The stated development sequence is an adult first-in-human study followed by entry into the paediatric programme once initial safety and PK data are available. The CD4bs antibody class shows approximately 50 to 90%+ neutralisation breadth.
Not yet approved
Not yet approved
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Prevention
Administration route
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
To be determined.
Dosage
Investigational: 5, 20 and 40 mg/kg IV (HVTN 143/HPTN 109 protocol). Clinical trial material at 100 mg/mL.
40 mg/kg IV (protocol)
No approved regimen and no completed study yet reported. Per the HVTN 143/HPTN 109 protocol: VRC01.23LS 5, 20 or 40 mg/kg IV alone (Part A); and in Part B, two IV doses six months apart of VRC01.23LS with PGT121.414.LS and PGDM1400LS at 5+5+5, 20+5+5, 20+20+20, 40+5+5 or 40+40+40 mg/kg.
doses are from a 2023 protocol version and may have changed.
Not provided
Related entries
Main compound
VRC01 (mAb)
Related compounds
VRC01.23LS (mAb)
VRC07-523LS (mAb) (TMB-380)
Additional information
Developer(s)
IAVI
VRC01.23LS is listed in IAVI's engineered bNAb portfolio as the CD4 binding site component, reported in October 2023 as manufactured with clinical trial material available at 100 mg/mL for HVTN 143/HPTN 109, for adult first-in-human study followed by entry into the paediatric programme. The VRC01 lineage originates from the NIAID Vaccine Research Center.
NIAID Vaccine Research Center (VRC)
The NIAID Vaccine Research Center isolated and developed the VRC01 lineage of CD4 binding site antibodies, including VRC01, VRC01LS and VRC07-523LS, and holds the class-foundational patent WO2011038290 through the US Department of Health and Human Services.
Drug structure
Scale-up and manufacturing prospects
Clinical trial material reported available at 100 mg/mL in 2023.
Not provided
Not disclosed. Described as a second-generation VRC01-class antibody with LS Fc modification. Manufacturing route, cell line and process are not public.
Not provided
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
No clinical safety data identified.
No efficacy data identified. Class breadth for CD4bs antibodies is approximately 50 to 90%+.
Evidence limited to a protocol document (HVTN 143/HPTN 109 v1.0, 7 June 2023) and IAVI portfolio material presented October 2023.
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL