CytoDyn is a publicly traded late stage biotechnology company developing innovative treatments for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH.
The Next Generation of Monoclonal Antibody Therapy
CytoDyn is committed to enhancing the lives of patients through target specific medicine. Our team is focused on developing Leronlimab, a monoclonal antibody CCR5 receptor antagonist, to be used as a platform drug for a variety of indications.
How it Works
The target of Leronlimab (PRO 140) is the important immunologic receptor CCR5. The CCR5 receptor is a protein located on the surface of a variety of cells including white blood cells and cancer cells. On white blood cells, it serves as a receptor for chemical attractants called chemokines. The CCR5 receptor is also the coreceptor needed for HIV to infect healthy T-cells. Recent research has identified the CCR5 receptor as an important target for many disease processes including cancer metastasis and certain immunological conditions.
What Makes Leronlimab Different
Leronlimab is a unique humanized monoclonal antibody. Leronlimab prevents HIV from using the CCR5 receptor as an entry gateway for healthy cells; preclinical research has also shown that Leronlimab blocks calcium channel signaling of the CCR5 receptor when present on the cancer cell surface. Calcium channel signaling of the CCR5 receptor is a crucial component to the spread of metastatic cancer.
Due to its selectivity and target specific mechanism of action, Leronlimab allows chemokine binding (CCL3, CCL4) at therapeutic doses and does not have agonist activity of the CCR5 receptor (it does not activate the immune function of the receptor). This target specificity separates Leronlimab from other CCR5 antagonists. Other advantages of Leronlimab include improved safety profile, longer half-life, and less frequent dosing.
Why CCR5 is a Favorable Target
The CCR5 receptor has been identified as a target in HIV, GVHD, NASH, cancer metastasis, transplantation medicine, multiple sclerosis, traumatic brain injury, stroke recovery, and a variety of inflammatory conditions. As we progress in evaluating Leronlimab (PRO 140) via a pathways approach, we are encouraged by the opportunity to build a broad pipeline of indications through label expansion following initial approval for multi-drug resistant HIV.
Nader Z. Pourhassan, PhD
Director, President and CEO
Dr. Pourhassan received his Bachelor of Science from Utah State University in 1985, his Masters of Science from Brigham Young University in 1990 and his Ph.D. in Mechanical Engineering from the University of Utah in 1998. Dr. Pourhassan has authored three books.
His 20 years of business development experience set the stage for him to transform a publicly traded biotech company on the brink of bankruptcy, into a company on the cusp of potentially obtaining FDA approval for its first drug. If granted approval, the drug called leronlimab (PRO 140) could change the treatment paradigms in both HIV and metastatic cancer.
Dr. Pourhassan joined CytoDyn (CYDY) in 2008 as Chief Operating Officer and by September, 2012, was appointed President and CEO. He was responsible for identifying significant opportunities for leronlimab, and single handedly raised enough capital for CytoDyn to complete an acquisition of PRO 140 from Progenics Pharmaceuticals. Dr. Pourhassan has overseen the rapid preclinical and clinical developments of leronlimab (PRO 140) as a therapy for HIV, from Phase 2 development into successful completion of Phase 3 trials. This includes the oversight of the development of trial protocols and interaction with the U.S. Food and Drug Administration (FDA). Dr. Pourhassan also opened the door for exploring leronlimab (PRO 140) for other indications, most notably, he has been involved in the preclinical and clinical developments of leronlimab in indications for triple-negative breast cancer, colon cancer, GvHD, and NASH.
To advance the drug development of leronlimab, Dr. Pourhassan raised capital for CytoDyn of approximately $200 million over the last 5 years.
Scott A. Kelly, MD
Chief Medical Officer, Head of Business Development and Chairman of the Board
Dr. Kelly was named Chairman of the Board in December 2018 and he has served as a director since April 2017. Dr. Kelly was named to the non-executive position of Chief Science Officer of the Company in July 2019. He was appointed Chief Medical Officer and Head of Business Development in April 2020. Prior to leaving clinical medicine to focus on CytoDyn, he served at Atlanta-based Resurgens Orthopaedics since 2002, including as Director of the Safety Council since 2013 and as Medical Director of the Resurgens Orthopaedics' Spine Center since 2007. He is a fellow of the American Board of Physical Medicine and Rehabilitation and a diplomate of the American Academy of Physical Medicine and Rehabilitation. He also is a member of the Spine Intervention Society, Georgia Society of Interventional Spine Physicians, and American Academy of Physical Medicine and Rehabilitation. He has received numerous honors including being named as America's Best Physicians in 2018 by the National Consumer Advisory Board, Leading Physicians of the World in 2018 by the International Association of Healthcare Professionals (IAHCP), America's Most Honored Professionals in 2018 and 2019 by The American Registry, America's Best Physicians in 2016, 2017, 2018, and 2019 by The National Consumer Advisory Board, "Top Doctor" in 2015, 2016, 2017, and 2019 by Castle Connolly, and "Top Doctor" by Atlanta Magazine in 2016, 2017 2018, and 2019. He is the author of What I've Learned from You: The Lessons of Life Taught to a Doctor by His Patients. He received his BA in Psychology from Emory University, his medical doctorate from Medical College of Georgia and completed his medical residency at Emory University.
Nitya G. Ray, PhD
Chief Technology Officer - Head of Process Sciences, Manufacturing & Supply Chain
Dr. Ray rejoined CytoDyn in December 2018 and previously served as the company's Senior Vice President of Manufacturing from November 2015 to June 2017. Most recently, Dr. Ray served as Executive Vice-President, Head of Product Development, Manufacturing and Supply Chain of Actinium Pharmaceuticals, Inc. Prior to joining CytoDyn in 2015, Dr. Ray was Senior Vice President at Progenics Pharmaceuticals, Inc. During his 14-year tenure at Progenics he was responsible for manufacturing, process & analytical sciences & quality control. He possesses extensive knowledge of leronlimab (PRO 140) development. Dr. Ray successfully manufactured the first 10 batches of leronlimab at Progenics under GMP, which was approved by the FDA for use in all clinical trials.
Dr. Ray’s return to CytoDyn brings 30 years of progressive, hands-on experience in strategic planning and execution of process development and manufacturing of biologics, engineered tissue therapeutics, antibody drug conjugates, and small molecule and radiopharmaceutical drugs. He has demonstrated expertise in diverse technology platforms, product development, pre-clinical, clinical and commercial manufacturing, process and analytical sciences, quality control, global supply chain, quality systems and regulatory affairs. Dr. Ray holds a Ph.D. in Biochemical Engineering and a M.S. degree in Chemical & Biochemical Engineering from Rutgers University and a B.S. degree in Chemical Engineering from Jadavpur University.
Brendan P. Rae, PhD, JD
Senior Vice President of Business Development
Dr. Rae is an accomplished licensing and business development executive with a proven track record of deal-making. Dr. Rae comes to CytoDyn from Serina Therapeutics where he was Chief Business Officer, responsible for partnering, out licensing and overall company strategy. Previously, Dr. Rae was the Executive Director of NPS Pharmaceuticals and Head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015. Prior to NPS, Dr. Rae held the role of Chief Business Officer at Arrowhead Research and Vivaldi Biosciences, as well as senior leadership roles at VIA Pharmaceuticals, Purdue Pharma and Hoffman-La Roche. Prior to entering the biopharmaceutical industry, Dr. Rae was an attorney specializing in biopharmaceutical intellectual property law and, earlier in his career was a research scientist focusing on metastasis and the molecular basis of cellular transformation. Dr. Rae holds a Juris Doctor degree from Seton Hall Law School and a Ph.D. in Virology from Glasgow University (Scotland) and completed a Postdoctoral Fellowship at the Roche Institute of Molecular Biology.
Michael D. Mulholland
Interim Chief Financial Officer
Mr. Mulholland was appointed Interim Chief Financial Officer in April 2020. He joined the Company in December 2012 and previously served as Chief Financial Officer, Treasurer and Corporate Secretary until November 2019, at which time he assumed a new role as Executive Advisor to the CEO and Senior Vice President-Finance. Mr. Mulholland brings to CytoDyn over 30 years of senior level financial leadership for public companies in the business services, retail and manufacturing industries. His broad experience includes strategic planning, corporate finance, including raising debt and equity capital, acquisitions, corporate restructurings, SEC reporting, risk management, investor relations and corporate governance matters. In addition to his financial management experience, Mr. Mulholland has also managed IP-asset development for the chemical inventions of a leading European scientific inventor for improving human health, working with IP counsel to evaluate and prosecute domestic and foreign patent applications. From 2011-2012, he served as Chief Financial Officer of Nautilus, Inc., a NYSE-listed developer and marketer of fitness equipment. He previously was Co-Chief Financial Officer of Corporate Management Advisors, Inc., a private holding company of various businesses and investments, including a majority interest in a publicly held manufacturing company, from 2010 to 2011; Vice President of Finance of Gevity HR, Inc., a former Nasdaq-listed professional employer organization, from 2008 to 2009; Chief Financial Officer and Corporate Secretary of Barrett Business Services, Inc., a Nasdaq-listed business services firm, from 1994 to 2008; and Executive Vice President, Chief Financial Officer and Corporate Secretary of Sprouse-Reitz Stores Inc., a former Nasdaq-listed retail company, from 1988 to 1994. He began his career with Deloitte & Touche LLP. Mr. Mulholland received a BS in accounting and a MBA in finance from the University of Oregon. He is a certified public accountant (inactive).
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