On May 3, 2021 CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it is preparing a request for a pre-Breakthrough Therapy designation (BTD) meeting ahead of preparing a Phase 3 clinical trial protocol for 22 solid tumor cancer indications (Press release, CytoDyn, MAY 3, 2021, View Source [SID1234578995]). The Company is extremely encouraged about the prospects of a Phase 3 trial and BTD based on preliminary indications of patients in the Company’s current Phase 2 basket trial, compassionate use study and a patient treated under an eIND, which may support a smaller trial.
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Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, stated, "We are very encouraged by leronlimab’s potential to control metastasis by blocking CCR5 overexpression in cells that undergo malignant transformation. We also believe in the potential of leronlimab in the tumor microenvironment, including decreased angiogenesis, macrophage polarization, and blocking T regulatory cells that turn off the immune system’s ability to fight cancer."
Dr. Kelly recently presented "The Role of Leronlimab to Treat TNBC" at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 and added, "We appreciate the warm reception of our oncology colleagues at the TNBC digital summit, and the recognition of the potential of leronlimab’s role in the future of immunotherapy."
Nader Pourhassan, Ph.D., President and Chief Executive Officer, commented, "Our multi-pathway approach to exploring all potential indications for leronlimab is proving to be very encouraging. We look forward to accelerating our efforts in the oncology field with leronlimab. We are equally excited to update our stockholders on Wednesday, especially concerning the potential use of leronlimab in treating COVID-19 in severe, critical, and long-hauler populations."
About Leronlimab (PRO 140)
Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.
CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the submission. CytoDyn expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar 2021.