CytoDyn Inc. has announced promising results from a study evaluating leronlimab in combination with antiretroviral therapy (ART) and broadly neutralizing antibodies (bNAbs) for HIV control. The research, conducted in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV), suggests that this novel immunotherapy approach could potentially allow for viral control without the need for continuous ART.
The study, which will be presented at the 5th annual HIV Research for Prevention Conference, explored whether early ART initiation combined with bNAbs and leronlimab could provide sustained viral control in infant rhesus macaques. This approach aims to reduce or eliminate the need for lifelong daily medication.
Study Design and Results
The study involved eighteen infant rhesus macaques infected with SHIV. The animals were treated with various combinations of ART, bNAbs, and leronlimab. The efficacy of these treatments was evaluated over a 27-week period, followed by a treatment interruption to monitor for virus rebound.
The combination of ART, bNAbs, and leronlimab demonstrated promising results. Notably, no virus rebound was observed in any of the treated animals, suggesting the potential for durable viral control and a significant step towards minimizing or eliminating the need for ongoing ART. According to Jonah B. Sacha, Ph.D, Chief of the Pathobiology and Immunology Division at the Oregon National Primate Research Center at Oregon Health & Science University, the results demonstrate a previously unappreciated synergy between CCR5 blockade and antibody neutralization that opens the door to a new approach for an HIV cure that should be explored further.
Leronlimab and CCR5 Blockade
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells. CCR5 is believed to play a role in numerous disease processes, including HIV infection. By blocking CCR5, leronlimab may help to prevent the virus from entering and infecting cells.
Implications for HIV Treatment
The current standard of care for HIV involves lifelong ART, which can be burdensome for patients and may be associated with long-term side effects. The development of therapies that could allow for ART-free viral control represents a significant unmet need in the field. These findings suggest that leronlimab, in combination with other agents, could potentially offer a new approach to HIV treatment.
"The potential for a treatment path for HIV utilizing leronlimab that allows for long-lasting viral control and potentially reduces or eliminates the need for ongoing ART is a thrilling prospect," said Dr. Jay Lalezari, CEO of CytoDyn. The company is continuing to progress its clinical development pipelines for leronlimab across a number of clinical indications.
