elipovimab (GS-9722) / Gilead, Xencor - LARVOL DELTA

HIV ENVELOPE DIVERSITY AND SENSITIVITY TO bNAbs ACROSS STAGES OF ACUTE AND EARLY HIV (CROI 2022) - "Susceptibility to bNAbs elipovimab (EVM; PGT121 derivative) and 3BNC117 was determined using previously described env signatures. Similarly, susceptibility to bNAbs did not differ by stage of AEHI before or after ART. Collectively, these data argue against major differences in HIV diversity or bNAb sensitivity across AEHI stage or following more than one year of suppressive ART and suggest individuals who initiate ART during AEHI as a desirable population for bNAb treatment or cure trials."

Human Immunodeficiency Virus • Infectious Disease

VIRAL AND BIOMARKER OUTCOMES OF AN ENGINEERED bNAb IN ART-SUPPRESSED PARTICIPANTS (CROI 2022) - "We evaluated viral reservoirs and HIV-specific T cell responses in ART-suppressed participants receiving the bNAb elipovimab (EVM), an engineered variant of PGT121 with enhanced Fc-gamma receptor binding. EVM may engage the immune system and augment HIV-specific T cell response in PWH harboring bNAb sensitive viruses. Whether bNAbs can facilitate clearance of the replication competant latent HIV reservoir remains an area of interest and would likely require combinations of bNAbs to increase the breadth of coverage of diverse viruses."

Biomarker • Human Immunodeficiency Virus • Infectious Disease

Evaluation of Broadly Neutralizing Antibody Sensitivity by Genotyping and Phenotyping for Qualifying Participants to HIV Clinical Trials. (PubMed, J Acquir Immune Defic Syndr) - "The genotypic assessment was found to be as predictive as the direct measurement of bNAb sensitivity by phenotyping and may, therefore, be preferred because of more rapid turnaround time and assay simplicity. A significant number of the participants were predicted to have virus sensitive to EVM and 3BNC117 and could, thus, be potential participants for clinical trials involving these bNAbs."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Evaluation of HIV-1 reservoir size and broadly neutralizing antibody (bNAb) susceptibility in individuals who initiated ART during acute and chronic infection (IAS-HIV 2021) - "Early treated individuals had lower reservoir size, lower viral diversity and higher susceptibility to bNAbs (exemplified by elipovimab) supporting that individuals who initiate ART during Fiebig stages, and in particular during Fiebig I to IV, would be an attractive population for early proof of concept bNAb cure-related trials. The IPDA provides both intact and total HIV DNA measurements and was able to differentiate between early and late cohorts and should therefore be given priority as a reservoir measurement in HIV cure trials."

Clinical • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] EVALUATION OF bNAb SENSITIVITY BY GENOTYPING AND PHENOTYPING FOR HIV CLINICAL TRIALS (CROI 2021) - " Pre-ART plasma virus from 96 participants in the Zurich Primary HIV Infection Study, who initiated ART during primary HIV infection, was genotyped and phenotyped for susceptibility to the bNAbs elipovimab (EVM, formerly GS-9722) and 3BNC117. The genotypic assessment using the developed Env signatures for sensitivity appears as predictive as the direct measurement of sensitivity by phenotyping and may therefore be preferred due do turnaround time and assay simplicity. A significant number of the analyzed participants had Env sequences that are susceptible to EVM and 3BNC117 and could thus be potential candidates for trials involving these bNAbs."

Clinical • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] SAFETY & PHARMACOKINETICS OF GS-9722 IN HIV-NEGATIVE PARTICIPANTS AND PEOPLE WITH HIV (CROI 2020) - "GS-9722 is a derivative of the bNAb PGT121 which has demonstrated immune cell-mediated killing of HIV-infected cells in vitro and efficacy in SHIV-infected monkeys. These studies demonstrate that GS-9722 is generally safe and well tolerated in HIV-negative participants and VS-PWH, with similar single dose PK in the two populations. These data support ongoing evaluation of GS-9722 as part of a combination therapy for HIV cure."

Clinical • PK/PD data • Gene Therapies • Hematological Disorders • Infectious Disease • Thrombocytopenia

GS-9722: FIRST-IN-CLASS EFFECTOR-ENHANCED BROADLY NEUTRALIZING ANTIBODY FOR HIV CURE (CROI 2019) - "GS-9722 is a first in class effector-enhanced bNAb for the targeted elimination of HIV infected cells and is currently in Ph1b clinical testing. Future studies will explore GS-9722 in combination with additional effector enhanced bNAbs, immune-modulatory agents (i.e. GS-9620), latency reversal agents and therapeutic vaccines in a multi-pronged approach to reduce or eliminate the HIV reservoir."