Gilead presents PoC data for investigational combination of lenacapavir, bNAbs

Gilead Sciences announced data evaluating lenacapavir in combination with broadly neutralizing antibodies teropavimab and zinlirvimab as a potential long-acting treatment regimen with twice-yearly dosing. Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV. These data were presented at the 30th Conference on Retroviruses and Opportunistic Infections. The study evaluated the safety and efficacy profile of lenacapavir + teropavimab + zinlirvimab in selected adults living with HIV who were virologically suppressed for greater than or equal to2 years while taking antiretroviral therapy. Study participants were sensitive to both bNAbs by HIV proviral DNA phenotype and had a CD4 cell count of greater than or equal to500 at study entry. The median age was 44 years. Doses of teropavimab and zinlirvimab were weight-based, with participants randomly allocated in a 1:1 ratio into two active treatment groups replacing their baseline ART with lenacapavir + teropavimab + zinlirvimab. At Week 26, 90% of participants receiving the complete study regimen maintained virologic suppression. At Week 12, one participant withdrew from the study with documented viral suppression. At Week 16, one participant had a confirmed virologic rebound and later resuppressed on baseline oral ART. There were no serious adverse events, including no grade 4 or 5 AEs, and no AEs that led to study drug discontinuation. Two participants experienced grade 3 AEs with one experiencing injection site cellulitis and the other experiencing injection site erythema. The combination of lenacapavir with teropavimab and zinlirvimab will advance to a Phase 2 study later this year in virologically suppressed people living with HIV. The study will assess two different dose levels of the bNAbs and assess safety and efficacy of the regimen in participants followed longitudinally for multiple doses of the study regimen. Lenacapavir is being developed as a foundation for future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination with other antiretroviral agents for treatment or as monotherapy for prevention, that help address individual patient needs and preferences. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s prevention and treatment research program.