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. (OTCQB: CYDY) will host a virtual R&D Update on December 7, 2022, at 11:00 a.m. ET. The event will feature presentations by key management and Scientific Advisory Board members discussing the clinical development of leronlimab, a CCR5 antagonist. Presenters include Cyrus Arman, M.D., who will overview the R&D strategy; Mazen Noureddin, M.D., discussing leronlimab's potential in treating NASH; Stefan Glück, M.D., focused on cancer therapy; and Jonah Sacha, Ph.D., on HIV research. The event can be accessed via the company's website.
CytoDyn (OTCQB: CYDY) announced the voluntary withdrawal of its Biologics License Application (BLA) for leronlimab, aimed at treating HIV-MDR patients. The decision stems from concerns over data quality from a clinical research organization (CRO). Despite meeting primary endpoints in trials, the company believes FDA approval is unlikely without substantial investments. CytoDyn plans to respond to a clinical hold and continue exploring leronlimab's effectiveness in other areas, including NASH and oncology, where promising results have been observed. A webcast will provide further updates on these developments.
CytoDyn Inc. (OTCQB: CYDY) announces significant changes to its Board of Directors with the appointments of Stephen Simes and Ryan Dunlap as independent directors. Simes brings over 40 years of experience in biopharmaceuticals, having successfully led various companies, while Dunlap has 25 years of finance and operations expertise. The changes aim to enhance the board’s independence and industry experience, following the resignation of Dr. Scott Kelly as a director, although he remains Chief Medical Officer. This strategic move is positioned to strengthen corporate governance and focus on CytoDyn's therapeutic developments.
CytoDyn Inc. (OTCQB: CYDY) announced an investment community webcast scheduled for September 28, 2022, at 1:00 pm PT / 4:00 pm ET. The event will feature Board Chair Tanya Urbach, President Cyrus Arman, CFO Antonio Migliarese, and CMO Scott Kelly, who will provide a quarterly update on the company's developments, particularly regarding leronlimab, a CCR5 antagonist. Questions for the webcast can be submitted until Noon PT on September 26, 2022. A replay will be available after the event until October 28, 2022.
CytoDyn Inc. (OTCQB: CYDY) announced the appointment of Dr. Cyrus Arman as President effective July 9, 2022. He brings over 15 years of experience, most recently serving as Chief Business Officer at Nimble Therapeutics. Dr. Arman is expected to transition to Chief Executive Officer and join the Board of Directors within six months. Board Chair Tanya Urbach expressed confidence in his leadership, highlighting his strategic abilities to enhance shareholder value and advance the company’s drug, leronlimab, which targets various medical conditions. Antonio Migliarese resumes his role as CFO.
CytoDyn (CYDY) announced a $5 million grant awarded to Oregon Health & Science University (OHSU) for preclinical research on a gene therapy based on leronlimab aimed at providing a functional cure for HIV. The study will examine the potential of a single-injection gene therapy utilizing adeno-associated virus (AAV) vectors to express the leronlimab protein, possibly eliminating the need for lifelong antiretroviral treatments. The research could pave the way for innovative anti-HIV therapies, aligning with NIH's ongoing efforts in HIV management.
CytoDyn (OTCQB: CYDY) announced that key executives, including Board Chair Tanya Urbach and CFO Antonio Migliarese, will host a webcast on June 30, 2022, to update the investment community. The presentation will provide a quarterly update regarding the company’s progress and developments, focusing on leronlimab, a CCR5 antagonist under development for multiple therapeutic uses. Participants can submit questions ahead of the event and access the replay afterward until July 30, 2022.
CytoDyn Inc. (OTCQB: CYDY) announced a non-cash settlement with former Chief Medical Officer Dr. Richard Pestell related to ongoing legal disputes. The agreement involves releasing claims, returning 8.3 million shares held in escrow, assets from ProstaGene LLC, and a warrant for 7 million shares at $0.37 each. The company aims to restore credibility and seeks to reengage Dr. Pestell to enhance the development of leronlimab, a potential therapeutic for various diseases, including cancer. CFO Antonio Migliarese expressed optimism about utilizing Dr. Pestell's expertise.
CytoDyn Inc. (OTCQB: CYDY) announced the addition of four prominent figures to its Scientific Board of Advisors, enhancing its expertise in biotechnology and immunotherapy. Dr. Paul Edison, Dr. Kabir Mody, and Dr. Otto Yang bring extensive backgrounds in neuroscience, oncology, and T cell immunology, respectively. Dr. Jacob (Jay) Lalezari will serve as an outside Scientific Advisor without compensation. These appointments aim to advance the development of leronlimab, a CCR5 antagonist under investigation for various therapeutic uses, including cancer and infectious diseases.
CytoDyn Inc. (OTCQB: CYDY) announced the publication of a peer-reviewed study in PLOS Pathogens demonstrating the efficacy of their CCR5 antagonist, leronlimab, in managing HIV. The study tracked five HIV+ patients who maintained viral suppression on leronlimab monotherapy for over seven years, despite a higher incidence of transient viral blips compared to traditional therapies. Additionally, research in rhesus macaques showed leronlimab reduced SHIV viral loads significantly. The company continues its focus on multiple therapeutic indications for leronlimab.