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CytoDyn’s Phase 3 Trial of Leronlimab (Vyrologix™) Demonstrates 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients; Webcast Monday

On March 05, 2021, 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, reported that the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in survival rate, and faster hospital discharge in critically ill COVID-19 patients. The trial’s data has been reported to the U.S. Food and Drug Administration (FDA), the U.K.’s Medicines & Healthcare product Regulatory Agency (MHRA) and Health Canada (HC), and the company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill populations. A manuscript of the trial’s data is being prepared and will be submitted for publication in one or more major medical journals. Highlights from the trial’s data for this critically ill population include the following:
--Survival Benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab arm versus the placebo arm of the study.
--Shortened Time to Recovery: The average length of hospital stay was reduced by 6 days for patients who received leronlimab with "commonly used COVID-19 treatments,” also referred to as “Standard of Care” or “SoC,” compared to placebo patients who received SoC only, with a statistically significant p-value of 0.005.
--Discharged Alive: In addition, patients who received leronlimab demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.

Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions. The company has continued to enroll patients (45) through the open-label arm of the CD12 trial, and is working with regulators here and abroad to expedite this process.

COMMENTS

Harish Seethamraju, MD, Medical Director for the Mount Sinai Lung Transplantation Program, commented, “The CD12 trial results are very promising and leronlimab may be the only safe medication to help critically ill patients.”

Scott A. Kelly, MD, Chairman and Chief Medical Officer of CytoDyn, noted, “We believe this further supports CCR5 as a therapeutic target for immunomodulation and the importance of the disruption of the CCL5-CCR5 axis via leronlimab-mediated CCR5 blockade of pro-inflammatory leukocytes and reversal of the cytokine storm in critical COVID-19 patients.”

Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented, “Today, there are no approved drugs to effectively address the unmet medical need for critically ill COVID-19 patients. Our CD12 study demonstrates leronlimab is particularly effective in treating this patient population. We believe these results are the best results ever achieved for this population in a Phase 3 clinical trial.”

“A recently approved IL-6 blocker used to treat severe to critical hospitalized COVID-19 patients requiring mechanical ventilation, reduced mortality by 2% compared to the placebo group. In contrast, leronlimab demonstrated a reduction of 24% in mortality compared to the SoC treated group, which is 12 times better in reducing all-cause mortality for critically ill COVID-19 patients. The company is very excited about these results and is concurrently working with regulators here and abroad to expedite leronlimab’s approval to treat COVID-19.”

WEBCAST SCHEDULED FOR MONDAY, MARCH 8

CytoDyn has also announced that the company will hold an investment community webcast on Monday, March 8, to provide an overview of the leronlimab CD12 trial data and the regulatory path forward with the U.S., U.K., Canada, Philippines, and Brazil.

Nader Pourhassan, PhD, President and Chief Executive Officer; Scott Kelly, MD, Chairman and Chief Medical Officer; Mahboob Rahman, MD, PhD, Chief Scientific Officer; and Harish Seethamraju, MD, Medical Director for the Mount Sinai Lung Transplantation Program, will host the webcast. Management will discuss the data from the recently completed Phase 3 trial of leronlimab for severe-to-critically ill COVID-19 patients, the regulatory path forward with several countries, as well as updates on other clinical and corporate priorities. The webcast will begin at 4:00 pm EST.

Management will provide approximately 90 minutes to address questions submitted online by analysts and investors.
Prior to the webcast, questions can be submitted online to CYDY_Team@cytodyn.com.

During the webcast, questions can be submitted through the webcast link below. (This also the link to the live webcast.)
https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/44...

This will be a listen-only webcast. Additional details of the webcast can be accessed here:
https://www.cytodyn.com/newsroom/press-releases/detail/502/cytodyn-to-ho...

LERONLIMAB (PRO 140)

The FDA has granted a Fast-Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is 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 non-alcoholic steato-hepatitis (NASH). Leronlimab has completed 11 clinical trials in over 1,200 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 by the FDA in May 2019.

GRAFT-VERSUS-HOST DISEASE

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 was conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the company suspended its Phase 2 trial for acute GvHD.

CYTODYN

Based in Vancouver, Washington, CytoDyn 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 NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to refile its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address its written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of calendar year 2021.

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, it 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 serious adverse effects (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 on CytoDyn can be found 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 on 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.

[Trial data press release] [Webcast details] [Webcast link] [CytoDyn]