Syndicate content

CytoDyn Submits Completed BLA* to FDA for Leronlimab As Combination Therapy, with HAART, for Highly-Treatment-Experienced HIV Patients; In FDA Review Period, Cytodyn Will Dedicate All Resources to Ensure Availability of Leronlimab for COVID-19 Patients

On Monday, April 27, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA (*biologics license application) to the FDA for leronlimab as a combination therapy, with HAART (highly active antiretroviral therapy),** for highly-treatment-experienced HIV patients. The FDA previously granted both Fast-Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication. “The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization. We are excited about the opportunity to introduce a novel therapeutic to HIV patients. In addition to the BLA submission, once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients has reached its objectives, we plan to initiate a registration-directed study. Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential,” said Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn. “With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer, and immunology. The BLA filing is a monumental achievement for our Company, and was made possible through the sheer determination and commitment of CytoDyn’s team and the Amarex Clinical Research (https://www.amarexcro.com/services.html) team led by Dr. Kush Dhody, Senior Vice President of Clinical Operations.”

“I would like to especially recognize Dr. Nitya Ray, the Cytodyne’s Chief Technology Officer, whose work in leading the CMC program was very crucial to CytoDyn. Dr. Ray was also instrumental in consummating the Samsung Biologics (https://www.samsungbiologics.com/front/en/main.do) contract to ensure we have sufficient large-scale biologics manufacturing capacity in place to meet the expected demand growth in a cost-effective and timely fashion. I would like to thank all of those involved for their tireless efforts,” concluded Dr. Pourhassan.

ENROLLING PATIENTS FOR TWO CLINICAL TRIALS OF LERONLIMAB—IN MILD/MODERATE COVID-19 & IN SERIOUS/CRITICAL COVID-19

CytoDyn is currently enrolling patients in two clinical trials for COVID-19: a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the USA and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact.

Corona viruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure.

Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-1.

Please see lay media stories on the success of leronlimab treatment of COVID-19 at the links provided below.

["Vancouver Biotech Company Tests COVID-19 Treatment--The Drug Is Called Leronlimab," KOIN-6 TV (Portland) article (April 25, 2020)]
["SF Doc Sees Promise in HIV Drug As Treatment for COVID-19," Bay Area Reporter (April 21, 2020)]
["COVID-19 Patient Credits Recovery to Drug Developed by Vancouver Biotech Company," KGW8 TV (Portland) article (April 15, 2020)]
["Southern California’s Race for a COVID-19 Cure Is Moving at ‘Lightning Speed,'" NBC4 TV (Southern California) article (April 13, 2020)]
["Coronavirus Survivor Credits Artificial Antibody Experimental Treatment for Recovery," NBC4 TV (Southern California) article (April 10, 2020)]
["Coronavirus Survivor Credits Artificial Antibody Experimental Treatment for Recovery," KCAL9 CBS TV (Los Angeles) article (April 10, 2020)]
["CytoDyn Enrolls First Two Patients in Phase 2 COVID-19 Trial with Leronlimab," RTTNews (April 6, 2020)]
["HIV Drug Leronlimab, Which Successfully Treats Coronavirus, Moving to Phase 2 Trials," NY Post (April 4, 2020)]

INVESTOR COMMUNITY CONFERENCE CALL

Please also access a replay of CytoDyn’s April 27 Investor Community Conference call (https://www.cytodyn.com/investors/news-events/ir-calendar/detail/2998/in...) for more information, particular on the success of leronlimab in the treatment of COVID-19. You may also access a replay of this call via phone at the following numbers: 877-660-6853(USA); 201-612-7415 (International), and use conference ID#: 13702767.

LERONLIMAB (PRO 140)

The FDA has granted a “Fast-Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first is 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 monoclonal antibody (Ab) that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH (non-alcoholic steatohepatitis).

Leronlimab has 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).

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 of leronlimab in metastatic triple-negative breast cancer and was granted Fast-Track designation in May 2019.

IMMUNE CELL TRAFFICKING & 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 is currently 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 has granted “orphan drug” designation to leronlimab for the prevention of GvHD.

CYTODYN

CytoDyn is a late-stage biotechnology company, headquartered in Seattle, Washington, which is developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 chemokine 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 completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy, with HAART, for highly-treatment-experienced HIV patients.

CytoDyn is also conducting 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 with no reported drug-related serious adverse events (SAEs). 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 five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

Please find more information at www.cytodyn.com.

Please also access CytoDyn’s April 27 Investors Conference call (https://www.cytodyn.com/investors/news-events/ir-calendar/detail/2998/in...) for more information, particular on the success of leronlimab in the treatment of COVID-19. ADD PHONE NUMBERS

*biologics license agreement

**a term coined in the late 1990s to describe the effectiveness of combination drug therapies used to treat HIV

[CytoDyn Press Release (April 27, 2020)]
[CytoDyn Investment Community Conference Call (April 27, 2020)]
[CytoDyn]
[About CytoDyn]
[CytoDyn Science]