Delving into the Latest Updates on VRC-01-LS with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

VRC-HIVMAB-080-00-AB, VRC 01LS, VRC01LS

Target

HIV envelope protein gp120

Action

inhibitors

Mechanism

HIV envelope protein gp120 inhibitors

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication-

Originator Organization

National Institute of Allergy & Infectious Diseases

Active Organization

National Institutes of Health

Inactive Organization

National Institute of Allergy & Infectious Diseases

Xencor, Inc.

License Organization-

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 177375L

Sequence Code 4701666H

Background:
The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it.
Objective:
To see if VRC01LS and VRC07-523LS are safe and well tolerated.
Eligibility:
Adults ages 18-70 who are HIV infected but otherwise healthy.
Design:
Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes.
Participants were monitored for 30 minutes after the infusion.
Blood samples were taken at the following times:
* Once before the infusion
* 5 times in the 4 hours after the infusion
* 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours.
For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary.
There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.

Start Date24 Apr 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT02797171

/ CompletedPhase 1IIT

A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the Serum and Mucosa of Healthy, HIV-Uninfected Adult Participants

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Start Date01 Mar 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with VRC-01-LS

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100 Translational Medicine associated with VRC-01-LS

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100 Patents (Medical) associated with VRC-01-LS

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13

Literatures (Medical) associated with VRC-01-LS

25 Feb 2026·CLINICAL INFECTIOUS DISEASES

Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study

Article

Author: Yin, Dwight E ; Sakoi, Maureen ; Moyo, Sikhulile ; Hong, Seohyun ; Lockman, Shahin ; Ajibola, Gbolahan ; Maphorisa, Comfort ; Batlang, Oganne ; Niesar, Aischa ; Jean-Philippe, Patrick ; Shapiro, Roger L ; Makhema, Joseph ; Hughes, Michael D ; Nelson, Bryan S ; Holme, Molly Pretorius ; Mohammed, Terence ; Kuritzkes, Daniel R ; Lichterfeld, Mathias ; Lancien, Melanie

Abstract:

Background:

Broadly neutralizing antibodies (bNAbs) are a promising treatment option for children with HIV-1, but their long-term impact on virologic, immunologic, and clinical outcomes is unknown.

Methods:

The Tatelo Study investigated dual bNAbs as an alternative to standard antiretroviral treatment (ART) in children. Children received bNAb-only treatment for 24 weeks (or until detectable viremia ≥400 copies/mL occurred) and were followed initially through 24 weeks after restarting ART. We continued follow-up from 24 to 96 weeks post-bNAb intervention to identify the long-term clinical, immunologic, and viral reservoir outcomes.

Results:

Median age at the start of long-term follow-up was 4.9 years (range 3.4, 6.8 years). From 23.0 to 43.6 weeks post-bNAb intervention, all 25 children transitioned to dolutegravir-based ART; 3 (12%) had a single episode of HIV-1 RNA ≥ 40 copies/mL after starting the DTG-based regimen and re-suppressed with adherence counseling on the same regimen. There were no grade 3 or 4 events, and no child died. Absolute CD4 cell counts remained stable at 96 weeks post-bNAb intervention (median: 1130 cells/mm3, IQR: 840, 1249 cells/mm3), and clinical biomarkers (serology, qualitative HIV DNA) were stable. At last available sampling, only 8 (32%) participants had detectable intact provirus (5 had rebounded during the bNAb-only intervention phase), with a low median HIV-1 DNA in PBMCs of 0.39 log10 (range 0.1 to 3.8 log10) copies/106 cells.

Conclusions:

There was no long-term impact on safety, clinical, immunologic, or virologic outcomes after bNAb-only treatment, including for children who rebounded during the intervention. These findings support further bNAb treatment trials in children.

Clinical Trials Registration:

Clinicaltrials.gov, NCT03707977, https://clinicaltrials.gov/.

16 Feb 2026·JOURNAL OF CLINICAL INVESTIGATION

Immune correlates of HIV-1 rebound during broadly neutralizing antibody treatment in young children

Article

Author: Roseto, Isabelle ; Yu, Xu G ; Sakoi-Mosetlhi, Maureen ; Gao, Ce ; Maphorisa, Comfort ; Batlang, Oganne ; Maswabi, Kenneth ; Shapiro, Roger L ; Tan, Toong Seng ; Ajibola, Gbolahan ; Moyo, Sikhulile ; Carrington, Mary ; Mohammed, Terence ; Lichterfeld, Mathias ; Lockman, Shahin ; Powis, Kathleen M ; Niesar, Aischa ; Hong, Seohyun ; Hartana, Ciputra Adijaya ; Makhema, Joseph ; Carrere, Leah ; Pretorius Holme, Molly ; Hua, Renee ; Parsons, Elizabeth ; Kuritzkes, Daniel R ; Naasz, Chloe ; Lancien, Melanie

Broadly neutralizing antibodies (bnAbs) are evaluated as possible alternatives to standard antiretroviral treatment (ART) for maintaining control of HIV-1 replication and may enhance immune responses to reduce or control the viral reservoir. However, the immunological and virological effects of bnAbs in infants and children are unknown. We conducted a detailed analysis of proviral reservoir dynamics and antiviral immune responses in a unique group of young children from Botswana who started ART at birth and then stopped standard ART while receiving the bnAbs 10-1074 and VRC01-LS in a subsequent clinical trial. No quantitative changes in frequencies of proviral sequences were observed during bnAb treatment, but selection of genome-intact proviruses in transcriptionally repressive heterochromatin regions occurred in some study participants. Faster viral rebound following standard ART cessation was linked to elevated proportions of KIR2DL1-positive NK cells. In contrast, delayed viral rebound and more limited viral reservoir size were associated with elevated proportions of NKG2A-positive NK cells and with the HLA-B-21M signal peptide polymorphism. HIV-specific T cell responses were low in all study participants and unrelated to viral reservoir sizes or clinical outcomes following ART interruption. These results suggest that, in young children, specific NK cell subsets and KIR-HLA interactions might be linked to HIV-1 rebound kinetics after substitution of standard ART with bnAbs.

01 Jul 2025·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Predictive Markers for Sustained Viral Suppression on Dual Broadly Neutralizing Antibodies During Antiretroviral Treatment Interruption in Children

Article

Author: Maswabi, Kenneth ; Sakoi-Mosetlhi, Maureen ; Lockman, Shahin ; Litcherfeld, Mathias ; Kuritzkes, Daniel R. ; Shapiro, Roger ; Batlang, Oganne ; Makhema, Joseph ; Hughes, Michael D. ; Maphorisa, Comfort ; Boleo, Corretah ; Ajibola, Gbolahan ; Banga, Jaspreet ; Mohammed, Terence ; Powis, Kathleen M. ; Moyo, Sikhulile ; Pretorius Holme, Molly ; Nelson, Bryan S.

Background::

Simple clinical markers may predict favorable outcomes in pediatric HIV treatment and cure trials. We report findings for biomarker combinations evaluated during the broadly neutralizing antibodies (bNAbs)–only step of the Tatelo Study in Botswana.

Methods::

Twenty-five children on antiretroviral treatment since birth received up to 24 weeks of bNAb-only treatment (VRC01LS + 10-1074). Suppression was defined as maintaining HIV RNA <400 copies/mL. HIV qualitative DNA and HIV RNA were performed every 1–2 weeks and enzyme immunoassay (EIA) every 4–8 weeks.

Results::

The median age of children at study entry was 3.7 years [interquartile range (IQR) 3.1–4.4]. At the start of bNAb-only treatment, 13/25 (52%) had negative qualitative DNA, 17/25 (68%) had negative EIA, and 10/25 (40%) were negative for both. Nine of 13 (69%) with negative qualitative DNA remained suppressed compared with 2/12 (17%) with positive or indeterminate qualitative DNA [odds ratio (OR) 11.3, 95% confidence interval (CI): 1.7 to 76.9]. Nine of 17 (53%) with negative EIA remained suppressed compared with 2/8 (25%) with positive EIA (OR 3.4, 95% CI: 0.5 to 21.7). Combining biomarkers, 8/10 (80%) who were negative/negative remained suppressed, compared with 3/15 (20%) with any other pattern (OR 16.0, 95% CI: 2.2 to 118.3). In the visit immediately before rebound, HIV RNA target detection occurred in 1/14 (7%) of failures.

Conclusion::

At the start of bNAb-only treatment, negative qualitative DNA, and especially negative/negative DNA and EIA, have potential to predict maintenance of viral suppression among children on dual bNAbs. HIV RNA target detection below the assay limit did not prove to be a clinically useful biomarker in the visits preceding rebound.

100 Deals associated with VRC-01-LS

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	Botswana	National Institute of Allergy & Infectious Diseases	17 Jun 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03707977 (Tatelo, Pubmed \| Clin Infect Dis)	Phase 1	HIV Infections	25	10-1074VRC01LS + 10-1074VRC01LS	iijfozkvrl(yrmmpoohii) = gkrvnacghn ccxycdcyuc (uxyyntvzgr, 840 - 1249) View more	Positive	25 Feb 2026
NCT02840474 (Pubmed \| JCI Insight)	Phase 1	HIV Infections CD4-binding site-specific	16	VRC01LS	oggguexcpj(rioqjfinod) = Mild local reactogenicity was only reported in participants who received VRC07-523LS qrbbtnniyk (csdvxzlhln ) View more	Positive	24 Feb 2025
				VRC07-523LS
NCT02256631 (CTgov)	Phase 1	HIV Infections	83	VRC01 (Dose Group 1)	dhhyxjpkca = teuqjnmgdm ffzdcegkjy (mrnjfhqgco, bpwtnvanob - tpmeghvgrl) View more	-	23 Aug 2021
				VRC01 (Dose Group 2)	dhhyxjpkca = qqlyhkidpy ffzdcegkjy (mrnjfhqgco, azhcrgdnrd - tibodrlxnx) View more
Pubmed \| J Infect Dis	Phase 1	HIV Infections	83	VRC01LS 80mg	bdzkqjhhbb(zxxbttcymq) = ziexslspll lbqhunkmph (jzbgulusek, + 71.6)	-	02 May 2021
				VRC01LS 100mg	bdzkqjhhbb(zxxbttcymq) = nfbuvldlhu lbqhunkmph (jzbgulusek, + 11.6)
NCT02840474 (CTgov)	Phase 1	HIV Infections	16	VRC-HIVMAB080-00-AB (Part A: VRC01LS (40 mg/kg))	bazldehkgo = iidcqolzmc qquldzxnak (qmqxpsfwuc, bxftmvtdwd - neyqkjobuk) View more	-	23 Feb 2021
				VRC-HIVMAB075-00-AB (Part B: VRC07-523LS (40 mg/kg))	bazldehkgo = ffffftgpoe qquldzxnak (qmqxpsfwuc, oytcwyoylp - erwyymmlzr) View more
VRC 607/ACTG 5378 (IAS2019)	Not Applicable	HIV Infections	16	VRC01LS	pbzneymwsy(yjdnnzkolb) = rtlwvstbam lsqsdtyibi (cqhnmkgiqq )	-	01 Jan 2019
				VRC07-523LS	pbzneymwsy(yjdnnzkolb) = gzksrtazye lsqsdtyibi (cqhnmkgiqq )
NCT02599896 (Pubmed \| PLoS Med) Manual	Phase 1	HIV Infections	37	VRC01LS	qbhdbcxxva(aicztqiwog) = ogtflejwkt qlpkalceeb (lqgeozotph ) View more	Positive	24 Jan 2018

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