IAVI: New Phase 1 trial launches to evaluate IAVI-developed HIV broadly neutralizing antibody

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PedMab1-Ex, led by SAMRC and Ospedale San Raffaele, aims to assess ePGT121v1-LS for eventual use to prevent HIV acquisition by infants and young children.

IAVI news release

Nearly 120,000 children still acquire HIV each year, often due to exposure during breastfeeding in communities with high HIV circulation. A new long-acting option to protect infants from HIV transmission during breastfeeding could help to fill critical gaps.

Broadly neutralizing antibodies (bnAbs) could potentially meet key needs by protecting infants from multiple strains of HIV. IAVI and partners developed a promising bnAb, ePGT121v1-LS, from blood samples taken during Protocol G — a cohort study run by IAVI that collected samples from adult participants living with HIV globally. This antibody was selected for further development following evidence of strong potency in pre-clinical trials.

On July 6, 2026, the South African Medical Research Council (SAMRC) in partnership with the group led by Dr. Gabriella Scarlatti, Group Leader of the Unit of Viral Evolution and Transmission at IRCCS Ospedale San Raffaele, announced the kickoff of a Phase 1 clinical trial to assess the safety and pharmacokinetic profile of ePGT121v1-LS. This trial, PedMAb1-Ex, will first enroll 26 healthy adult volunteers to inform dose selection and administration strategies for the planned infant trial, which will begin after favorable safety data is collected.

Read the full news release here.

 

Source : IAVI

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