CytoDyn Inc., a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it signed an agreement with amfAR, The Foundation for AIDS Research, to test the ability of Vyrologix (leronlimab) to mediate a functional HIV cure. The international organization, amfAR, plays a vital role in AIDS research by identifying critical gaps in the knowledge of HIV and AIDS and supporting groundbreaking studies.

In 2007, Timothy Brown, also known as the “Berlin patient,” became the first documented person cured of HIV following a stem cell transplant from a CCR5-deficient donor. Subsequent attempts to cure HIV via stem cell transplant from donors expressing CCR5 failed, indicating the critical role of CCR5 deficiency in HIV cure. Last year, Adam Castillejo, formerly the “London patient,” became the second documented case of HIV cure after a stem cell transplant from a CCR5-deficient donor.

While it is now recognized that CCR5 is central to these two documented cases of HIV cure, natural CCR5-deficient individuals are rare and finding such donors is extremely difficult. Recently, Vyrologix (leronlimab) successfully protected macaques from retroviral infection, mirroring the protection from HIV seen in CCR5 deficient individuals. CytoDyn’s partnership with amfAR will advance clinical studies to incorporate Vyrologix to mimic a CCR5-deficient stem cell donor and attempt to functionally cure an HIV+ person receiving a stem cell transplant from a donor expressing CCR5.

“Using leronlimab to pharmacologically copy a CCR5-deficient donor for HIV cure is an exciting next step in our journey towards a cure for the 38 million people living with HIV,” stated Kevin Robert Frost, Chief Executive Officer at amfAR. “While a stem cell transplant is unlikely to be rolled out as an HIV cure, demonstrating that leronlimab can functionally phenocopy CCR5 deficiency and replicate the London and Berlin patients would be a major advancement.” As part of the agreement, CytoDyn will provide leronlimab and study support, while amfAR will support groundbreaking study sites to incorporate leronlimab in their cure studies.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are honored to be in partnership with amfAR and the opportunities to accelerate a search for an HIV cure using this scientific premise. Timothy Brown’s cure ignited hope that a cure can happen through bone marrow transplant from the rare individuals with a delta-32 mutation. The success in our animal studies for HIV with Vyrologix (leronlimab) has provided this opportunity. We are very excited to be supporting this project, and to be a part of this groundbreaking endeavor with amfAR.”