VANCOUVER, Wash., April 12, 2022 (GLOBE NEWSWIRE) — CytoDyn Inc. (CYDY) (“CytoDyn” or the “Company”), a biotechnology company in the late-stage development of leronlimab, a CCR5 antagonist with the potential multiple therapeutic indications, today announced the publication of a peer-reviewed research paper titled “Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5-Specific Antibody Leronlimab in Two Species” in the open access journal PLOS Pathogens.
The study followed five HIV-positive human participants who, after successfully transitioning to once-weekly subcutaneous leronlimab, discontinued their previous daily regimens of oral antiretroviral therapy. These five participants were from an extension study, consisting of virologically suppressed patients in a previous leronlimab study. Of the ten patients enrolled in the extension study, four people experienced viral rebound and discontinued leronlimab monotherapy, and one person withdrew, leaving five long-term participants. All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for more than seven years, with no evidence of viral escape. Importantly, these five participants on leronlimab monotherapy had a higher frequency (7.1%) of transient episodes of plasma viremia, called viral blips, than those on combined oral antiretroviral regimens (2.0%). . To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment reduced SHIV viral loads 10,000-fold, and leronlimab was found in all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively.
Jonah Sacha, Ph.D., the study’s lead author, who is scientific advisor to CytoDyn and a professor at Oregon Health & Science University, said, “To our knowledge, these data represent the longest administration of monoclonal antibody monotherapy for HIV in people with Date.”
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to the CC chemokine receptor type 5 (CCR5), a protein surface of some immune systems. cells thought to play a role in many disease processes. CytoDyn is studying leronlimab in several therapeutic areas, including infectious diseases, cancer and autoimmune diseases.
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 the 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 leronlimab, the Company’s ability to resolve clinical holds recently imposed by the FDA, the safety and efficacy of leronlimab and the Company’s ability to obtain regulatory approval for sales. commercial. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed in such statements due to risks and uncertainties, including: (i) regulatory determinations of safety and the effectiveness of leronlimab in treating the diseases and conditions for which we are reviewing the product by the US Food and Drug Administration (FDA) and various drug regulatory agencies in other countries; (ii) the ability of the Company to raise additional capital to finance its operations; (iii) the ability of the Company to honor its debts; (iv) the Company’s ability to recruit a permanent CEO and retain other key employees; (v) the Company’s ability to enter into partnership or license agreements with third parties; (vi) the Company’s ability to identify patients to enroll in its clinical trials in a timely manner; (vii) the timely and sufficient development, through internal resources or third-party consultants, of analyzes of data generated by the Company’s clinical trials required by the FDA or other regulatory agencies under the new submission of the Company’s BLA for the HIV indication or other Company’s drug product approval applications; (viii) the Company’s ability to obtain marketable product approval; (ix) the design, implementation and conduct of the Company’s clinical trials; (x) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (xi) the market and merchantability of any Approved Product; (xii) the existence or development of vaccines, drugs or other treatments that are considered by healthcare professionals or patients to be superior to the Company’s products; (xiii) regulatory initiatives, compliance with government regulations and the regulatory approval process; (xiv) legal proceedings, investigations or inquiries regarding the Company or its products; (xv) general economic and commercial conditions; (xvi) changes in foreign, political and social conditions; (xvii) actions or shareholder proposals relating to the Company, its management or its board of directors; and (xviii) various other matters, many of which are beyond the Company’s control. The Company urges investors to specifically consider the various risk factors identified in its most recent Form 10-K, as well as any risk factors or cautionary statements included in subsequent Forms 10-Q and 8-K, filed with of the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.
Cristina De Leon
Dan ZaccheiJoe Germani
Longacre Place Partners
[email protected] / [email protected]