CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the appointment of Seenu Srinivasan, Ph.D., as Executive Director-CMC Regulatory Affairs.
Dr. Srinivasan provides CytoDyn with 30 years of experience in pharmaceutical drug development, including extensive CMC development experience in developing APIs (small and large molecules) and drug products (biological and small molecules) from early phase to commercialization, strategy development and execution. He has led the CMC portions of development (process development/engineering, analytical development, formulation development, stability testing under cGMP conditions, and preparation of all technical documents for regulatory filing).
Dr. Srinivasan's career included serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led the CMC strategy and successfully submitted a monoclonal antibody based BLA (Dupixent approved in 2017). Prior to Regeneron, Dr. Srinivasan served as Global Vice President/Chief Scientific Officer, CMC Pharmaceutical Development Services for Covance Laboratories Inc. (a Laboratory Corporation of America Holdings company) where his primary responsibilities included strategy development, P&L responsibility for the business unit, all CMC activities and API development under cGMP for Phase 1 and 2 and cGMP stability, and CMC project/program management. Dr. Srinivasan earned B.Sc. Ed. (Chemistry and Physics, First Class), Regional College of Education, Mysore, India, M.Sc. (Chemistry, First Class), Indian Institute of Technology, Madras, India, M.S. (Education) and Ph.D. (Chemistry), Purdue University, and was a Postdoctoral Research Fellow (Electrochemistry), at Michigan State University.
Dr. Srinivasan, commented, "I am very excited about the opportunity to join CytoDyn at such an important time when our management team can define and shape the Company's future by advancing our multi-pathway approach to evaluating leronlimab for so many potential indications."
Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer, stated, "We are very fortunate to add Dr. Srinivasan to our CMC regulatory management team. His deep experience and proven leadership qualities will clearly enable him to be a strong contributor in setting the strategic course for our long-term future."
About 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, among various potential applications, 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 ...
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