Drug name
Last update: Sep 2026VRC07-523LS (mAb) (TMB-380)
Drug information
VRS07-523LS; VRC-HIVMAB075-00-AB; TMB-380
Not applicable (investigational; no brand name assigned)
Biotherapeutic
bNAb targeting gp120 on HIV-1 virus envelope
VRC07-523LS (VRC-HIVMAB075-00-AB; TMB-380) 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. TaiMed develops TMB-380 as part of the antibody-only TMB-365/TMB-380 regimen at 4,800 mg IV every 8 weeks. VRC07-523LS is an engineered VRC01-class antibody with the LS Fc modification, neutralising 96% of strains at IC50 below 50 microgram/mL and 92% below 1 microgram/mL, with 5- to 8-fold greater potency than VRC01.
Not yet approved
Not yet approved
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Administration route
Intravenous, Subcutaneous, Intramuscular
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Every 3 months
- Every 6 months
- Every 2 months
- Every 4 months
To be determined. In CAPRISA 012A (with PGT121), 86.7% of African women found two to three subcutaneous administrations per year acceptable for HIV prevention. Generally safe and well tolerated across phase 1 studies.
Dosage
Investigational: weight-based 5 to 40 mg/kg (5 mg/kg; 20mg/kg; 40mg/kg) IV or SC; fixed doses 400 mg to 3,200 mg IV; 1.2 g SC (CAPRISA 012C); 2,400, 3,200 and 4,800 mg IV (TaiMed programme).
40 mg/kg IV (phase 1); 4,800 mg IV fixed dose (as TMB-380)
No approved regimen. Examples: with CAB-LA (ACTG A5357); 1.2 g SC every 6 months with CAP256V2LS (CAPRISA 012C part B); 4,800 mg IV every 8 weeks with TMB-365 4,800 mg IV. ; VRC07-523LS 20 mg/kg IV Q12W- 3 doses ; VRC07-523LS 5 mg/kg SC Q12W- 3 doses
Not provided
Not provided
Related entries
Main compound
VRC01 (mAb)
Related compounds
VRC07-523LS (mAb) (TMB-380)
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.
TaiMed Biologics
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