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VRC01.23LS (mAb)

Developer(s)

IAVI

Originator
http://www.iavi.org/united-states/neutralizing-antibody-center/

United States

VRC01.23LS is listed in IAVI's engineered bNAb portfolio as the CD4 binding site component, reported in October 2023 as manufactured with clinical trial material available at 100 mg/mL for HVTN 143/HPTN 109, for adult first-in-human study followed by entry into the paediatric programme. The VRC01 lineage originates from the NIAID Vaccine Research Center.

NIAID Vaccine Research Center (VRC)

Originator
https://www.niaid.nih.gov/about/vrc

United States

The NIAID Vaccine Research Center isolated and developed the VRC01 lineage of CD4 binding site antibodies, including VRC01, VRC01LS and VRC07-523LS, and holds the class-foundational patent WO2011038290 through the US Department of Health and Human Services.

Drug structure

Placeholder

Placeholder

Drug information

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Administration route

Intravenous

Therapeutic area(s)

HIV

Use case(s)

Pre-Exposure Prophylaxis (PrEP)
Prevention

Use of drug

Ease of administration

Administered by a nurse
Administered by a specialty health worker

Frequency of administration

Every 6 months

User acceptance

To be determined.

Dosage

Available dose and strength

Investigational: 5, 20 and 40 mg/kg IV (HVTN 143/HPTN 109 protocol). Clinical trial material at 100 mg/mL.

Maximum dose

40 mg/kg IV (protocol)

Recommended dosing regimen

No approved regimen and no completed study yet reported. Per the HVTN 143/HPTN 109 protocol: VRC01.23LS 5, 20 or 40 mg/kg IV alone (Part A); and in Part B, two IV doses six months apart of VRC01.23LS with PGT121.414.LS and PGDM1400LS at 5+5+5, 20+5+5, 20+20+20, 40+5+5 or 40+40+40 mg/kg.

Additional comments

doses are from a 2023 protocol version and may have changed.

Dosage link(s)

Not provided

Drug information

Drug's link(s)

Not provided

Generic name

VRC01.23LS

Brand name

investigational

Compound type

Biotherapeutic

Drug class/category

mAb (Monoclonal antibody) — bNAb targeting the CD4 binding site of HIV-1 envelope gp120. Second-generation VRC01-class antibody with LS half-life extension.

Lifecycle status

Dormant / No Development Reported — Clinical trial material was reported available at 100 mg/mL in 2023 and a first-in-human trial was described as underway, with HVTN 143/HPTN 109 as the designated protocol (version 1.0 dated 7 June 2023).

Summary

VRC01.23LS is a second-generation VRC01-class broadly neutralising antibody targeting the CD4 binding site of the HIV-1 envelope glycoprotein gp120, carrying the LS Fc modification for half-life extension. It sits in IAVI's engineered bNAb (ebnAb) portfolio as the CD4bs component, alongside the V3-glycan antibody ePGT121v1-LS and a V2-apex antibody. IAVI portfolio material from October 2023 reported that VRC01.23LS had been manufactured, that a first-in-human trial was underway, and that clinical trial material was available at 100 mg/mL for HVTN 143/HPTN 109. The stated development sequence is an adult first-in-human study followed by entry into the paediatric programme once initial safety and PK data are available. The CD4bs antibody class shows approximately 50 to 90%+ neutralisation breadth.

Approval status

Not yet approved

Regulatory authorities

Not yet approved

Safety

No clinical safety data identified.

Efficacy

No efficacy data identified. Class breadth for CD4bs antibodies is approximately 50 to 90%+.

Evidence Summary

Evidence limited to a protocol document (HVTN 143/HPTN 109 v1.0, 7 June 2023) and IAVI portfolio material presented October 2023.

Delivery device(s)

No delivery device

Scale-up and manufacturing prospects

Scale-up prospects

Clinical trial material reported available at 100 mg/mL in 2023.

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not disclosed. Described as a second-generation VRC01-class antibody with LS Fc modification. Manufacturing route, cell line and process are not public.

Specific analytical instrument required for characterization of formulation

Not provided

Clinical trials

Not provided

Excipients

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Patent info

There are either no relevant patents or these were not yet submitted to LAPaL

Supporting material

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

Additional information

Not provided