Drug name
Last update: Apr 2026PGT121.414.LS + VRC07-523LS (mAb)
Drug information
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PGT121.414.LS (PGT121.BIJ414.LS) + VRC07-523LS combination
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Biotherapeutic
bNAbs targeting gp120 on HIV-1 virus envelope
PGT121.414.LS is a modified V3 glycan-targeting monoclonal antibody (mAb) derived from PGT121 and engineered with LS mutations (methionine-to-leucine and asparagine-to-serine) to extend serum half-life and enhance stability. Its elimination half-life is approximately 71 days, about threefold longer than that of parental PGT121, with dose-dependent peak serum concentrations (e.g., 714.2 µg/mL at 20 mg/kg IV). Co-administration with VRC07-523LS did not alter the pharmacokinetics of either antibody. However, the combination exhibited greater neutralization breadth and potency across diverse HIV-1 strains by both IV and SC administration. No serious adverse events or dose-limiting toxicities were observed, and all solicited adverse events were mild to moderate and resolved within 3–4 days.
This combination remains under clinical investigation and is not yet approved for therapeutic use.
This combination remains under clinical investigation and is not yet approved for therapeutic use.
Therapeutic area(s)
- HIV
- Treatment
Administration route
Subcutaneous, Intravenous
Associated long-acting platforms
Solution
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
- Every 4 months
Dosage
Adult dose: 400 mg-1600 mg (under clinical Investigation)
1600 mg
Regimen 1: VRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6 Regimen 2: VRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6 Regimen 3: PGT121.414.LS 20 mg/kg + VRC07-523LS 20 mg/kg by IV infusion sequentially in this order at Months 0, 4, and 8. Regimen 4: PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg by SC infusion sequentially in this order at Months 0, 4, and 8.
PGT121.414.LS has been evaluated in combination with VR207-523LS in a Phase 1 clinical trial. Based on the favourable safety and efficacy outcomes observed, a three-antibody regimen—comprising DVRC07-523LS (400 mg), PGT121.414.LS (400 mg), and PGDM1400LS—is currently under clinical investigation in phase 2 trials.
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Associated compounds, formulations and regimens
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Associated technologies
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Additional information
Developer(s)
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases is one of the 27 institutes and centers that make up the National Institutes of Health, an agency of the United States Department of Health and Human Services. Dr. Taubenberger was named the Acting Director of NIAID in April 2025. He oversees a $6.6 billion budget that supports research to advance the understanding, diagnosis, treatment.
Drug structure
Scale-up and manufacturing prospects
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Excipients & delivery device(s)
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Safety, Efficacy and Evidence Summary
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There are either no relevant patents or these were not yet submitted to LAPaL