VRC07-523LS
Phase 2Biologic
VRC07-523LS is an experimental antibody treatment being studied to prevent HIV infection in people at high risk of exposure to the virus.[1] VRC07-523LS is currently being investigated across 7 indications[3], with its most advanced program in Phase 2.[1]
VRC07-523LS is one of 164 biologic programs targeting HIV. It is currently in Phase 2.
7
Indications
20
Total Trials
11
Active Trials
163
Competitors
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
123 competitors in HIV Infection
#DrugCompanyPhaseTrials
1Norvir
AbbVieApproved
Tivicay
GSKApproved
Olumiant
Eli LillyApproved
Reyataz
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Mycobutin
PfizerApproved
Cabenuva
GSKApproved
Golytely
BayerApproved
Zofran
NovartisApproved
Zometa
PfizerApproved
Lotrimin
BayerApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
HIV3 trials
Phase I/II Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early Treated Children in Botswana
Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT06508749·41 enrolled
A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and in Vitro Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Administered in Multiple Doses and Routes to Adult Participants Without HIV-1
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT07390955·83 enrolled
A Randomized, Double Blind, Controlled, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06812494·200 enrolled
Intravenous2 trials
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03928821·27 enrolled
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04212091·33 enrolled
HIV-12 trials
HIV infection2 trials
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT02140255·1,120 enrolled
A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04340596·118 enrolled
HIV-1 infection1 trial
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
Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06987318·40 enrolled
10 more indications
Safety and Efficacy1 trial
Immunogenicity1 trial
Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults
Active, not recruiting·—·Phase 1/2·NCT04983030·36 enrolled
Combination Therapy1 trial
Monoclonal1 trial
Adult1 trial
Bispecific Antibody1 trial
Concentration1 trial
Clinical Trial1 trial
HIV Infections1 trial
RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission
Recruiting·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 1·NCT06484335·48 enrolled
Acute HIV Infection1 trial
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05719441·48 enrolled
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for VRC07-523LS. EMBL-EBI & Wellcome Sanger Institute.
- [4]
Details