CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn Inc. (CYDY) announced a significant advancement in the development of leronlimab, as it showed potential in preventing HIV infection through a study published in Nature Communications. The research indicated that leronlimab successfully prevented SHIV infection in nonhuman primates, paving the way for human trials as a pre-exposure prophylaxis (PrEP). The CEO expressed optimism about the drug’s future, highlighting its fewer side effects compared to current treatments and its potential in various therapeutic areas. CytoDyn is preparing to refile its Biologics License Application for HIV therapies soon.
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.
CytoDyn Inc. (OTC.QB: CYDY) announced a purchase order from Chiral Pharma Corporation in the Philippines for leronlimab, a treatment for critically ill COVID-19 patients. The order follows a Compassionate Special Permit and is expected to generate revenue upon fulfillment. The COO noted a significant 21% mortality rate among patients treated under CSP, with success stories highlighting improvements post-treatment. CytoDyn is also preparing an Emergency Use Authorization application in the Philippines amid ongoing clinical trials targeting HIV, cancer, and long-term COVID-19 symptoms.
CytoDyn Inc. (OTC.QB: CYDY) has announced plans by its Brazilian distribution partner, Biomm S.A., to submit an authorization request to the Brazilian National Health Surveillance Agency (ANVISA) for two Phase 3 clinical trials of leronlimab in treating COVID-19. The trials will target severe and critically ill patients with a total of 900 participants across 45 sites. CytoDyn aims to utilize leronlimab to potentially benefit thousands of COVID-19 patients in Brazil, while also preparing to explore similar partnerships in other countries facing COVID-19 surges.
CytoDyn Inc. (OTC.QB: CYDY) has promoted Antonio Migliarese to Chief Financial Officer, transitioning from Vice President, Corporate Controller. This change follows Michael Mulholland's shift to Senior Vice President of Finance for personal reasons. Migliarese, a CPA with extensive financial experience, will lead CytoDyn's financial organization as it evolves from a pre-revenue biotechnology company to a commercial entity. CytoDyn continues to develop its lead product, Vyrologix™ (leronlimab-PRO 140), with FDA Fast Track designation for HIV and metastatic cancer treatments.
CytoDyn Inc. (OTC.QB: CYDY) announced positive topline results from its CD12 Phase 3 clinical trial focusing on leronlimab for critically ill COVID-19 patients. The study demonstrated significant improvements in mortality rates, showing a 78% reduction with the first dose and 82% with the second. Secondary endpoints were met with statistically significant p-values. Despite not achieving the primary endpoint in the mITT population, CytoDyn aims to submit these findings to regulatory agencies for potential approval in countries like India and the Philippines.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for May 18, 2021, led by CEO Nader Pourhassan and other executives. The presentation will address ongoing communications with the FDA regarding trial design, focusing on the CD12 trial results for the COVID-19 treatment, leronlimab. The trial did not meet primary endpoint criteria; however, secondary endpoints in a critically ill sub-population showed promise. Investors are encouraged to submit questions before and during the webcast.
CytoDyn Inc. (OTC.QB: CYDY) has signed an exclusive agreement with Macleods Pharmaceuticals Ltd. to distribute leronlimab in India, targeting COVID-19 patients. This partnership aims to address the lack of approved treatments for critically ill COVID-19 patients in India. The agreement was finalized swiftly, and both companies are optimistic about leronlimab's potential to save lives. CytoDyn has also completed a pivotal Phase 3 trial for leronlimab in HIV treatment and plans to resubmit its Biologics License Application by Q3 2021.
CytoDyn Inc. (OTC.QB: CYDY) has announced that its drug candidate, leronlimab, will be featured in a one-hour segment on OneNews in the Philippines on May 9, 2021. Leronlimab has been provided to critically ill COVID-19 patients under Compassionate Special Permits from the Philippine FDA. The segment will include key executives from CytoDyn and medical professionals discussing the drug's potential benefits. Leronlimab has successfully met primary endpoints in clinical trials for HIV and is in the process of resubmitting its Biologics License Application.
CytoDyn Inc. (OTC.QB: CYDY) has partnered with Albert Einstein Israelite Hospital in São Paulo, Brazil, to conduct two Phase 3 COVID-19 trials aimed at seeking regulatory approval from ANVISA for leronlimab. These trials will enroll about 1,500 patients across 45 sites, with an interim analysis planned when 120 critically ill patients are enrolled. The Brazilian COVID-19 crisis intensifies with ICU capacity nearing full. CytoDyn believes these trials may facilitate Emergency Use Authorization (EUA) for leronlimab globally. The company plans to update shareholders on trial progress shortly.