Drug name
Last update: Aug 2026VRC07-523LS (mAb)
Drug information
VRS07-523LS
Not provided
Biotherapeutic
bNAb targeting gp120 on HIV-1 virus envelope
VRC07-523LS (VRC-HIVMAB075-00-AB) is a broadly neutralizing antibody (bNAb) engineered to target the CD4 binding site on HIV’s envelope protein gp120. It is a modified version of VRC01, with an LS mutation that extends its half-life, allowing less frequent dosing. Administered via IV, IM, SC, it has shown safety and tolerability in clinical trials. Furthermore, the estimated half life is 42 days.In combination with long-acting Cabotegravir, VRC07-523LS maintained HIV viral suppression in over 90% of participants over 48 weeks. It is being explored for both HIV prevention and treatment, potentially reducing the need for daily antiretroviral therapy. VRC07-523LS, was 5- to 8-fold more potent than VRC01 and considerably broader in vitro, with an IC50 <1 μg/mL against 92% of HIV-1 pseudovirus.
Not yet approved
Not yet approved
Therapeutic area(s)
- HIV
- Treatment
Administration route
Intravenous, Subcutaneous, Intramuscular
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 3 months
Dosage
5 mg/kg; 20mg/kg; 40mg/kg
40 mg/kg
VRC07-523LS 20 mg/kg IV Q12W- 3 doses VRC07-523LS 5 mg/kg SC Q12W- 3 doses
Not provided
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key institute within the National Institutes of Health (NIH) dedicated to advancing research on infectious, immunologic, and allergic diseases. Established over 60 years ago, NIAID conducts both basic and applied research aimed at improving understanding, diagnosis, treatment, and prevention of these diseases.
Drug structure
Scale-up and manufacturing prospects
Not provided
Bioreactors, incubators, filtration units, lyophilizers, and formulation vessels.
VRC07-5LS is a monoclonal antibody, and its production involves several key steps: VRC07-523LS is produced in a Chinese Hamster Ovary (CHO) DG44 cell line. Further information is not disclosed yet.
1. Bio-Plex Instrument (Bio-Rad) 2. Beckman Biomek Automation Platform 3. Surface-Plasmon-Resonance-(SPR)-Systeme 4. Dynamic Light Scattering, 5. Differential Scanning Calorimetry 6. Circular dichroism and isothermal chemical denaturation
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
VRC07-523LS antibody
Antibodies and antigen binding fragments that specifically bind to HIV-1 Env and neutralize HIV-1 are disclosed. Nucleic acids encoding these antibodies, vectors and host cells are also provided. Methods for detecting HIV-1 using these antibodies are disclosed. In addition, the use of these antibodies, antigen binding fragment, nucleic acids and vectors to prevent and/or treat an HIV-1 infection is disclosed.
WO2019165122
Compound
The United States of America
Not provided
February 21, 2039
Granted: US Pending: AU, CA, CN, EP, IN