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

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

VRC-HIVMAB-080-00-AB

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

Xencor, Inc.

National Institutes of Health

Inactive Organization

National Institute of Allergy & Infectious Diseases

License Organization-

Drug Highest PhasePhase 1

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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11

Literatures (Medical) associated with VRC-01-LS

26 Mar 2025·JAIDS Journal of Acquired Immune Deficiency Syndromes

Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children

Article

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

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 who were on ART 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 immunosorbent assay (EIA) every 4-8 weeks.Results:The median age of children at study entry was 3.7 years (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 (OR 11.3, 95% CI 1.7-76.9). Nine of 17 (53%) with negative EIA remained suppressed compared with 2/8 (25%) with positive EIA (OR 3.4, 95% CI 0.5-21.7). 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 2.2-118.3). In the visit immediately prior to viral 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 failure.

24 Feb 2025·JCI Insight

Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection

Article

Author: Santana-Bagur, Jorge L ; Novik, Laura ; Heath, Sonya L ; Happe, Myra ; Mascola, John R ; Tressler, Randall L ; Hu, Zonghui ; Carroll, Robin ; Wang, Jing ; Belinky, Frida ; Koup, Richard A ; Coates, Emily E ; Roa, Jhoanna C ; Strom, Larisa ; Dwyer, Bridget ; Pandey, Janardan P ; Bhatnagar, Anjali M ; Ko, Sung Hee ; Presti, Rachel M ; Lin, Bob C ; Ledgerwood, Julie E ; Chen, Grace L ; Basappa, Manjula ; Lynch, Rebecca M ; Tebas, Pablo ; Serebryannyy, Leonid ; Landovitz, Raphael J ; Holman, LaSonji A ; Koletar, Susan L ; McDermott, Adrian B ; Boritz, Eli A ; Narpala, Sandeep R ; Capparelli, Edmund V ; Namboodiri, Aryan M ; Fichtenbaum, Carl J ; Conan-Cibotti, Michelle ; Rothwell, Ro Shauna

BACKGROUNDHIV-1-specific broadly neutralizing monoclonal antibodies (bNAbs) have emerged as promising interventions with the potential to effectively treat and prevent HIV-1 infections. We conducted a phase I clinical trial evaluating the potent CD4-binding site-specific (CD4bs-specific) bNAbs VRC01LS and VRC07-523LS in people with HIV-1 (PWH) not receiving antiretroviral therapy (ART).METHODSParticipants received a single intravenous 40 mg/kg dose of either VRC01LS (n = 7) or VRC07-523LS (n = 9) and did not initiate ART for a minimum of 14 days. The primary study objective was to evaluate safety and tolerability; the secondary study objectives were to evaluate pharmacokinetics (PK) and the impact of administered bNAbs on viral loads (VL) and CD4+ T cell counts in the absence of ART.RESULTSThis trial enrolled 16 PWH aged 20 to 57 years. Both bNAbs were safe and well tolerated. Mild local reactogenicity was only reported in participants who received VRC07-523LS, while both bNAbs were associated with mild systemic symptoms. Maximum serum concentrations (Cmax) following VRC01LS or VRC07-523LS were 1,566 ± 316 and 1,295 ± 376 μg/mL, respectively. VRC07-523LS administration significantly decreased VL in 8 out of 9 participants, with an average decline of 1.7 ± 0.8 log10 copies/mL within 14 days after administration. In contrast, VRC01LS administration resulted in a smaller average decline (0.8 ± 0.8 log10 copies/mL), and 3 out of 7 participants showedno change in VL. Postinfusion maximum decline in VL correlated with post hoc baseline in vitro viral susceptibility results for both bNAbs.CONCLUSIONThe results of this trial support inclusion of potent CD4bs-specific bNAbs, such as VRC07-523LS, into next-generation treatment regimens for HIV-1.TRIAL REGISTRATIONClinicalTrials.gov NCT02840474.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID)/NIH (grants UM1 AI068634, UM1 AI068636, UM1 AI106701, UM1AI069424, UM1AI069501, UM1AI69415, UM1AI069534, UM1AI69494); the Intramural Research Program of the NIAID/NIH; National Center for Advancing Translational Sciences/NIH (grants UM1TR004548, UL1TR001881, and UL1TR001878); and the National Cancer Institute/NIH (contract 75N91019D00024).

05 Jul 2023·Science Translational MedicineQ1 · MEDICINE

Broadly neutralizing antibody treatment maintained HIV suppression in children with favorable reservoir characteristics in Botswana

Q1 · MEDICINE

Article

Author: Niesar, Aischa ; Makhema, Joseph ; Cooper, Marlene ; Reeves, Jacqueline D. ; Hughes, Michael ; Nelson, Bryan S. ; Bennett, Kara ; Hu, Zixin ; Yin, Dwight E. ; Pretorius Holme, Molly ; Caskey, Marina ; Ackerman, Margaret E. ; Capparelli, Edmund V. ; Giguel, Francoise ; Jean-Philippe, Patrick ; Moyo, Sikhulile ; Kuritzkes, Daniel R. ; Shapiro, Roger L. ; Powis, Kathleen M. ; Gao, Ce ; Mohammed, Terence ; Maphorisa, Comfort ; Lockman, Shahin ; Lichterfeld, Mathias ; Batlang, Oganne ; Reeves, Michael A. ; Maswabi, Kenneth ; Yu, Xu ; McDermott, Adrian ; Gama, Lucio ; Ajibola, Gbolahan ; Sakoi, Maureen

Broadly neutralizing antibodies (bNAbs) may provide an alternative to standard antiretroviral treatment (ART) for controlling HIV-1 replication and may have immunotherapeutic effects against HIV-1 reservoirs. We conducted a prospective clinical trial with two HIV-1 bNAbs (VRC01LS and 10-1074) in children (n= 25) who had previously initiated small-molecule ART treatment before 7 days of age and who continued treatment for at least 96 weeks. Both bNAbs were dosed intravenously every 4 weeks, overlapping with ART for at least 8 weeks and then continued for up to 24 weeks or until detectable viremia of HIV-1 RNA rose above 400 copies per milliliter in the absence of ART. Eleven (44%) children maintained HIV-1 RNA below 400 copies per milliliter through 24 weeks of bNAb-only treatment; 14 (56%) had detectable viremia above 400 copies per milliliter at a median of 4 weeks. Archived HIV-1 provirus susceptible to 10-1074, lower birth HIV-1 DNA reservoir in peripheral blood mononuclear cells, sustained viral suppression throughout early life, and combined negative qualitative HIV-1 DNA polymerase chain reaction and negative HIV-1 serology at entry were associated with maintaining suppression on bNAbs alone. This proof-of-concept study suggests that bNAbs may represent a promising treatment modality for infants and children living with HIV-1. Future studies using newer bNAb combinations with greater breadth and potency are warranted.

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	Discovery	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 (Pubmed \| J Acquir Immune Defic Syndr)	Phase 1/2	-	30	10-1074	adnkutjkxn(rvzvmyeejk) = There were no infusion reactions nor any bNAb-related grade 3 or 4 events wbwvwpkxug (bowqxnzmjh )	Positive	01 Oct 2022
				VRC01LS
NCT02256631 (CTgov)	Phase 1	HIV Infections	83	VRC01 (Dose Group 1)	cjbqhmfdyx(ocqnfbfvij) = swpccmxshz qtnumjvjge (opfflitwxy, blrkkieozx - yfetnrkehs) View more	-	23 Aug 2021
				VRC01 (Dose Group 2)	cjbqhmfdyx(ocqnfbfvij) = uoyonfastf qtnumjvjge (opfflitwxy, gzndjeourl - kuchrtdaps) View more
NCT02840474 (CTgov)	Phase 1	HIV Infections	16	VRC-HIVMAB080-00-AB (Part A: VRC01LS (40 mg/kg))	(zbzrdnjvmv) = mboxxbkaph zytvxmrcri (zpbtfghfgg, ajonyhepmo - szbfcsobxj) View more	-	23 Feb 2021
				VRC-HIVMAB075-00-AB (Part B: VRC07-523LS (40 mg/kg))	(zbzrdnjvmv) = dxqafyibml zytvxmrcri (zpbtfghfgg, ijgpyyibmn - ltblspnnob) View more
VRC 607/ACTG 5378 (IAS2019)	Not Applicable	HIV Infections	16	VRC01LS	(ggswkqvuea) = gkkwwzdhkd pducuvedjz (liqqwftagh )	-	01 Jan 2019
				VRC07-523LS	(ggswkqvuea) = nukwihhtem pducuvedjz (liqqwftagh )
NCT02599896 (Pubmed \| PLoS Med) Manual	Phase 1	HIV Infections	37	VRC01LS	(ldbgovjpxu) = jmraggjjmv vgiwqgisvz (hlitefeixx ) View more	Positive	24 Jan 2018

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