CytoDyn and Philippine Airlines Work Together to Provide Filipinos with the Best Possible Treatment Options In the Fight Against Covid-19

Rhea-AI Summary

CytoDyn (OTC.QB: CYDY) announced a collaboration with Philippine Airlines to fast-track the transportation of leronlimab, a treatment for critically ill COVID-19 patients, to the Philippines. CytoDyn has provided enough leronlimab to treat 100 patients at no cost under a Compassionate Special Permit. The partnership aims to expedite delivery from the U.S. to the Philippines, helping to save lives. Additionally, leronlimab is under investigation for HIV and metastatic cancer treatments and has received FDA Fast Track designation for both indications.

Positive

• Partnership with Philippine Airlines improves delivery logistics for leronlimab.
• CytoDyn provided leronlimab for free to treat 100 patients, enhancing goodwill and potential brand value.
• Vyrologix™ (leronlimab) has received FDA Fast Track designation for HIV and metastatic cancer.

Negative

• No current revenue from leronlimab as distribution is limited to compassionate use.
• Dependency on clinical trial outcomes for future marketability and revenue generation.

VANCOUVER, Washington, June 01, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab), a CCR5 antagonist with potential multiple therapeutic indications, announced today a joint collaborative effort with Philippine Airlines as the preferred partner in transporting leronlimab to the Philippines for treatment of critically ill COVID-19 patients.

CytoDyn recently provided the Philippines with enough leronlimab to treat 100 patients free of charge, distributed locally by Chiral Pharma Corporation for patients under Compassionate Special Permit (“CSP”). Philippine Airlines (“PAL”) has stepped up to help with one of the main challenges, the long delivery time from the USA to the Philippines. The flag carrier will help transport vials from Los Angeles to Manila on PAL’s nonstop flights, enabling the delivery of leronlimab to critical patients as quickly as possible.

“We believe that through the collaborative efforts of both companies, many Filipino lives can be saved,” said Mr. Oscar Z. Siangco Jr., COO of Chiral Pharma Corporation.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are pleased to announce this joint collaborative effort and would like to thank Philippine Airlines for their help in the fight against COVID-19 in the Philippines. Our efforts to bring leronlimab to people of Philippines will not stop as we are very grateful that we hear many patients and their doctors express very positive view of use of leronlimab under CSP in Philippines.”

“Our PAL Team is ready, able and eager to combat the pandemic by transporting life-saving therapeutics, equipment, vaccines and other medical supplies to the Philippines, using our state-of-the-art widebody airplanes with the range to fly long nonstop sectors from different continents,” said Mr. Jason T. Siy, PAL’s head of Cargo Business.

Filipinos can get more information on how to access leronlimab in the Philippines by contacting CytoDyn’s local distribution partner Chiral Pharma Corporation.

About Vyrologix™ (Leronlimab)
The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). Leronlimab has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with HIV standard care in patients with multi-drug resistance to current available classes of HIV drugs).

Leronlimab amongst many things, is a viral-entry inhibitor in HIV/AIDS. It binds to CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab does not work on other strains of HIV (for example X4), however R5 is the most dominant strain of HIV. Five 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. Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control (for example, through angiogenesis). 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 97% in a murine xenograft model. As a result, CytoDyn is conducting two clinical trials, one, a phase 1b/2 in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second, a phase 2, basket trial which encompasses 22 different solid tumor cancers.

The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial will evaluate the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. If this trial is successful, CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Preclinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH. NASH is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19 and oncology.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn has successfully completed a Phase 2b pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. 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 their written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of the calendar year 2021 or shortly thereafter. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used 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 approval. Clinical results to date from two trials have shown that leronlimab can keep the viral load suppressed in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once a week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load.

CytoDyn is also conducting a Phase 2 clinical trial with leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 long haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild to moderate and severe to critical COVID-19 patients, respectively. More information is at www.cytodyn.com. 

Forward-Looking Statements 
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about financial results (including revenues, expenses, liquidity and cash flow), leronlimab, its ability to provide positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTS
Investors:
Cristina De Leon
Office: 360.980.8524
cdeleon@cytodyn.com

FAQ

What is the significance of CytoDyn's partnership with Philippine Airlines?

The partnership helps transport leronlimab swiftly to the Philippines, enhancing access for critically ill COVID-19 patients.

How many patients can leronlimab treat in the Philippines?

CytoDyn has provided enough leronlimab to treat 100 patients free of charge under a Compassionate Special Permit.

What is leronlimab used for?

Leronlimab is being investigated for treating COVID-19 patients, HIV, and metastatic cancer.

What FDA designation has leronlimab received?

Leronlimab has received Fast Track designation from the FDA for HIV and metastatic cancer treatments.

What are the clinical trial statuses for leronlimab?

Leronlimab has completed multiple clinical trials and is currently under investigation for various indications, including COVID-19.