CytoDyn Abstract by Dr. Jonah Sacha for Use of Leronlimab as PrEP is Accepted by the Keystone Symposia on HIV Pathogenesis and Cure - Seite 2

“Over the past 15 years, HIV therapies have advanced significantly, however, there has been minimal prevention of HIV in the U.S. According to the CDC (Centers for Disease Control and Prevention), about 38,000 new infections occur annually the in U.S. alone. The potential for a once-monthly leronlimab injection for HIV prevention could be a significant step in eradicating HIV in the U.S. given its remarkable safety profile,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. Over 840 HIV patients have received leronlimab with zero drug-related SAEs. Its success as a HIV monotherapy (single-agent therapy) has been outstanding, with 5 patients exceeding 5 years of successful once-weekly, self-injections of leronlimab as a monotherapy. Additionally, approximately 150 patients in our ongoing Phase 2b/3 investigative monotherapy trial have maintained viral suppression with leronlimab for almost a year. A paradigm shift in HIV prevention could be significant with once-a-month injection of leronlimab,” added Dr. Pourhassan.

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) have granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.  Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including   NASH.  Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.