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Article Reporting Anecdotal Success of CytoDyn’s Leronlimab (Vyrologix™) in Treatment of Critically Ill COVID-19 Patients Accepted for Journal Publication; Four Patients, Initially on Mechanical Ventilators, Fully Recover After Leronlimab Treatment

On Decembr 30, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing Vyrologix™ (leronlimab) (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that a research manuscript submitted by first author Nicholas J. Agresti, MD, has been accepted for publication in the Journal of Translational Autoimmunity. The research findings of Dr. Agresti and colleagues were based on four critically ill COVID-19 patients treated with leronlimab under an FDA-approved emergency investigational new drug (eIND) application. All four were on mechanical ventilators and fully recovered following leronlimab treatment. Dr. Agresti is a gastroenterologist in the Southeast Georgia Health System. The manuscript (Ms. No. JTAUTO-D-20-00043R1) is entitled “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab.” The accepted research paper can be accessed here (https://d1io3yog0oux5.cloudfront.net/cytodyn/files/pages/cytodyn/db/256/...). Additional authors on the paper included Bruce Patterson, MD, CEO and Founder, Incell Dx; Kabir Mody, MD, Mayo Clinic; Jacob Lalezari, MD, CytoDyn advisor, now CMO at Virion; Jonah B. Sacha, PhD, Vaccine and Gene Therapy Institute and Oregon National Primate Research Center, Oregon; Harish Seethamraju, MD, Medical Director, Advanced Lung Failure and Lung Transplant, Montefiore Medical Center; Seth Gross, MD, NYU Langone Gastroenterology Associates; Scott Kelly, MD, CMO, CytoDyn; Nader Pourhassan, PhD, President and CEO, CytoDyn, and Kush Dody, MBBS, Vice President, Clinical Operations, Amarex Clinical Research, among others. Dr. Agresti stated, “We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19.” Co-author Dr. Pourhassan, President and CEO of CytoDyn, commented, “We are appreciative of Dr. Agresti’s work and view his publication as a validation of leronlimab as an important potential therapeutic in the treatment of seriously ill COVID-19 patients. Dr. Agresti’s four patients were treated with leronlimab under eIND. All four patients were on mechanical ventilator and they fully recovered.”

CORONAVIRUS DISEASE 2019

CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

LERONLIMAB (PRO 140) (VYROLOGIX™)

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is for 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 monoclonal antibody (mAb) that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

HIV/AIDS

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 could 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.

CANCER

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

GRAFT VERSUS HOST DISEASE (GvHD)

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, and that blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the company is suspending its Phase 2 trial for acute GvHD.

CYTODYN

CytoDyn, based in Vancouver, Washington, is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and non-alcoholic steato-hepatitis (NASH).

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab, in combination with standard antiretroviral therapies, in HIV-infected treatment-experienced patients. The FDA met telephonically with company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (“BLA”) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, this could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions have been reported in approximately 800 patients treated with leronlimab and no drug-related SAEs have been reported in patients treated with a 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at available at http://www.cytodyn.com.

DISCLOSURE

Michael D. O’Neill, Editor & Publisher of BioQuick News, has a very small amount of equity in CytoDyn. That very small holding had no effect in the selection and publication of this article. This article was selected and published solely on a consideration of its news value for the BioQuick News audience.

[CytoDyn press release] [Research article accepted by Journal of Translational Autoimmunity] [CytoDyn]