VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics - LARVOL DELTA

TMB-365 and TMB-380: A potentially resistance repellant stand-alone maintenance bNAb regimen in suppressed people living with HIV-1 on combination antiretroviral therapy (IDWeek 2026) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease

The Tatelo Plus Study (clinicaltrials.gov) - P1/2 | N=41 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

CAPRISA 012C: A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women (clinicaltrials.gov) - P2 | N=990 | Completed | Sponsor: Centre for Infectious Disease Research in Zambia

New P2 trial • Human Immunodeficiency Virus • Infectious Disease

RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine | Trial completion date: Aug 2027 ➔ Jul 2029 | Trial primary completion date: Aug 2027 ➔ Jul 2029

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

Combinatorial Therapy to Induce an HIV Remission (clinicaltrials.gov) - P1/2 | N=11 | Completed | Sponsor: University of California, San Francisco | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

VISTA: HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: TaiMed Biologics Inc. | Trial completion date: Aug 2027 ➔ May 2027 | Trial primary completion date: Aug 2027 ➔ May 2027

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

Safety and preliminary efficacy of 6-monthly subcutaneous CAP256V2LS plus VRC07-523LS for HIV prevention in African women: results of the CAPRISA 012C phase 2 randomised controlled trial (AIDS 2026) - "Fixed-dose subcutaneous CAP256V2LS plus VRC07-523LS was safe but not effective in reducing overall HIV incidence. Higher than expected bnAb resistance may explain the lack of overall efficacy as there was a trend towards protection for viruses sensitive to one or both bnAbs. Matching bnAbs with circulating viruses will be important for future bnAb studies."

Clinical • Late-breaking abstract • P2 data • Human Immunodeficiency Virus • Infectious Disease

Safety and virological outcomes of CAP256V2LS and VRC07-523LS administered at ART initiation with analytical treatment interruption: preliminary results from the NeutART HIV cure trial (AIDS 2026) - "Administration of CAP256V2LS and VRC07-523LS at ART initiation was safe and generally well tolerated. Viral rebound occurred rapidly during ATI among most participants, with similar VL kinetics across groups. These findings provide important early data on the feasibility and biological impact of administering bnAbs at ART initiation."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

IL-15 superagonist N-803, with or without bNAbs, induces temporary reduction and transcriptional activation of the intact HIV reservoir (AIDS 2026) - "A5386 is an open-label, phase 1 trial evaluating safety and tolerability of N-803 administered ± a single infusion of broadly neutralizing antibodies (bNAbs, VRC07-523LS, 10-1074LS). N-803 ± bNAbs induced a transient reduction of the intact reservoir alongside increased transcriptional activity, consistent with latency perturbation and enhanced proviral visibility. While this did not translate into sufficient ART-free viral control to meet the primary endpoint, these data provide evidence that IL-15-based strategies can meaningfully modulate the intact reservoir."

Human Immunodeficiency Virus • Infectious Disease

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Proof-of-Concept Development and Preclinical Evaluation of a Microarray Patch Platform for Codelivery of Multiple Broadly Neutralizing Antibodies for HIV Prevention. (PubMed, Mol Pharm) - "Here, we present proof-of-concept data on a minimally invasive microneedle (MN) patch platform codelivering three bnAbs, PGT121, VRC07-523LS, and PGDM1400LS, from separate MN patch units or pixels. These preliminary findings suggest that the MN patch platform may serve as a promising alternative to injectable bnAb formulations for HIV prevention and treatment, particularly in neonates and infants, although further investigation is required to establish its clinical utility. Additionally, the solid-state MN formulation of bnAbs may eliminate the need for cold-chain storage or distribution, making the patch particularly suitable for use in resource-limited settings."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Modeling quantifies in vivo neutralization, Fc-mediated killing, and resistance in human clinical trials of five anti-HIV broadly neutralizing antibodies. (PubMed, bioRxiv) - "We therefore performed a mathematical modeling meta-analysis which integrated four clinical trials and reproduced serial bnAb concentrations, viral loads, and bnAb sensitivities (IC50) in 43 viremic trial participants who received an infusion of VRC01, VRC01LS, VRC07-523LS, 3BNC117 or 10-1074. For each bnAb, our best model identified a scaling factor of 36-462 to pro j ect in vivo activity from in vitro IC50, quantified Fc-mediated infected cell killing in humans over time, and pro j ected the timing of bnAb-resistant strain emergence. Using this holistic profile, VRC07-523-LS was generally optimal."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

ENABLE 2: Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2) (clinicaltrials.gov) - P1/2 | N=73 | Not yet recruiting | Sponsor: Hospital Universitario 12 de Octubre

New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults (clinicaltrials.gov) - P1/2 | N=28 | Completed | Sponsor: Boris Juelg, MD PhD | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Primary Immunodeficiency • CD4

VISTA: HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: TaiMed Biologics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, VRC07-523LS, and PGT121.414.LS infused intravenously or subcutaneously (HVTN 140/HPTN 101 part B): a phase 1, randomised trial. (PubMed, Lancet HIV) - P1 | "The mAb combination of PGDM1400LS, PGT121.414.LS, and VRC07-523LS was safe and well tolerated, with no antagonistic pharmacokinetic interactions or loss of neutralisation activity. These findings support further evaluation of this combination in future efficacy trials."

Journal • P1 data • PK/PD data • Allergy • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Comment on: Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic-pharmacodynamic modelling in adults and infants. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • PK/PD data

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 (clinicaltrials.gov) - P1 | N=83 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Feb 2026 ➔ Jun 2026

Trial initiation date • Human Immunodeficiency Virus • Infectious Disease • CD4

Combinatorial Therapy to Induce an HIV Remission (clinicaltrials.gov) - P1/2 | N=11 | Active, not recruiting | Sponsor: University of California, San Francisco | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 (clinicaltrials.gov) - P1 | N=83 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Enhanced Clearance of HIV-1 Broadly Neutralizing Antibody VRC07-523-LS During Viremia: Influences on Trial Design and Analysis. (PubMed, Clin Transl Sci) - "With a viral load of 30,000 copies/mL, a 2100 mg dose of VRC07-523-LS is expected to result in 90% of participants having a concentration below 1 mg/L by 18.6 weeks, a decrease of 42 weeks compared to aviremic patients. Mechanistic modeling offers the ability to identify HIV viral load effects on BNAb PK and can improve BNAb dosing, especially with consideration of acute versus maintenance treatment."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic -pharmacodynamic modelling in adults and infants. (PubMed, J Antimicrob Chemother) - "Age and repeat dosing influence VRC07-523LS PK. An 80-mg dose followed by 100 mg at 12 weeks rapidly achieves and maintains concentrations >10 µg/mL for >24 weeks. This dosing strategy is expected to result in antiviral effects in patients with sensitive viruses and supports further evaluation of VRC07-523LS."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Monitoring broadly neutralising HIV antibody concentrations using microsampling on dried blood spots in infants. (PubMed, J Infect) - "DBS microsampling allows accurate bNAb concentration measure in neonates, which will facilitate on-going paediatric clinical trials and possible subsequent monitoring in adults with home-sampling if deployed at scale."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics