CYTODYN INC (OTC-QB)
1111 Main Street
Vancouver, WA 98660
Telephone: (360) 980-8524
Facsimile: (360) 980-8549
Web Site: http://www.cytodyn.com
CytoDyn believes in the future of precision medicine... more specificity, less side effects. Our target, the CCR5 receptor, has been implicated in multiple disease processes from HIV, GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson's disease, to metastatic cancer. Leronlimab, our CCR5 antagonist, is a once a week, subcutaneous injection. One molecule with multiple opportunities. With precision comes the opportunity for improved safety, convenience, and enhanced efficacy for the patient.
Building a Broad Pipeline of Indications
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.
CytoDyn operates under the guidance of a highly qualified management team and advisors with experience in a wide range of complementary skillsets, including business development, mechanical engineering, life sciences and biotech, manufacturing and clinical development, IP asset development, biologics, antibody drug conjugates, engineered tissue therapeutics, small molecule and radiopharmaceutical drugs and more.
Additionally, CytoDyn has established relationships with world-class HIV and Cancer experts who advise on the company's trial designs.
Drugs in Pipeline
- Positioning in multi-billion dollar markets: HIV-1, Cancer and GvHD
Has successfully completed HIV-1 Combo Pivotal Trial (PE achieved with p=0.0032; 81% of patients achieved suppressed viral load with HIV-1 RNA < 50 copies/mL; No SAEs).
Underway Clinical trials: Phase 3 for HIV-1 Mono, Phase 2 for non-HIV Graft vs. Host Disease (GvHD) and Phase 1b/2 for triple negative breast cancer (TNBC).
HIV-1 Combo BLA submissiion is expected to complete in 3Q19.
Leronlimab (PRO 140)
CytoDyn's lead product candidate, Leronlimab (PRO 140), belongs to a new class of HIV-1/AIDS and Cancer therapeutics intended to protect healthy cells from viral infection and supressing cancer cell metastasis. The Leronlimab (PRO 140) antibody appears to be a highly efficacious antiviral agent with minimum side effects or toxicity and less frequent dosing requirements, as compared to daily drug therapies currently in use.
Leronlimab (PRO 140) Highlights:
- Candidate has been used in more than 800 HIV-infected patients in 8 placebo-controlled and open-label FDA-approved clinical trials;
Was the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects; and
Is designated a "fast track" product candidate by the FDA
Leronlimab (PRO 140) has also demonstrated significant advantages over standard-of-care highly active antiretroviral therapy (HAART).
How PRO-140 works
Antibodies are soluble proteins that are produced by the body in response to infections from pathogens like bacteria and viruses. Each individual antibody is synthesized by a unique cell. The secreted protein is shaped like a Y and possesses two identical yet unique binding sites that are specific for a short segment of the offending pathogen.
Vaccines capitalize on the ability of the body to produce antibodies to foreign proteins, also known as antigens, by injecting the antigen of interest with an immune stimulating molecule referred to as an adjuvant. This causes the body to react by producing antibody molecules specific for different parts of the antigen.
Once the antigen is gone from the body the antibody producing cells revert to a dormant state until the antigen is again detected in the body. Then a brisk response ensues and antibody levels rapidly rise in the bloodstream to neutralize the antigen.
Because of the genetic uniqueness among species, antibodies can also be developed that are specific for normal cell proteins. For example, immunizing a mouse with human proteins allows one to produce mouse antibodies that can recognize virtually any human antigen. This has allowed for the development of a variety of diagnostic reagents and therapeutic antibodies specific for human cells.
In the 1980s, a team of scientists won the Nobel Prize in Medicine for developing a technique that fused a common type of tumor cell with a single mouse antibody producing cell. The resulting hybrid cells all secreted the exact same antibody as the original mouse antibody producing cell and thus were called monoclonal antibodies. Since they were part tumor cell, they could be kept virtually forever in a flask. Harvesting the fluid from these cells provided an unlimited amount of highly specific monoclonal antibodies.
Monoclonal antibodies have come to represent one of the fastest expanding opportunities in the biotechnology/pharma sector. The ability to transition from research reagents generated in mice to fully humanized structures suitable for clinical and commercial development has provided some of the most effective and largest selling therapeutics over the last 10 years.
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Nader Z. Pourhassan, Ph.D. – Director, President and CEO
Dr. Pourhassan was appointed a Director in September 2012 and has served as CytoDyn's President and Chief Executive Officer since December 2012. Prior to that, he was the Company's Managing Director of Business Development from June 2011 to December 2012, and Chief Operating Officer from May 2008 to June 2011. Dr. Pourhassan was responsible for identifying the opportunity with leronlimab (PRO 140) and instrumental in the acquisition of this asset. He has overseen the rapid clinical development of leronlimab (PRO 140) as a therapy for HIV from Phase 2 development and into Phase 3 trials including the development of trial protocols and interaction with the U.S. Food and Drug Administration (FDA). He also has been involved in preclinical and clinical development of leronlimab (PRO 140) in additional immunological indications. Dr. Pourhassan has led CytoDyn's capital market activities since joining the Company in 2008. He has more than 20 years of business development experience. 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.
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Michael D. Mulholland – CFO, Treasurer and Corporate Secretary
Mr. Mulholland brings to CytoDyn more than 25 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. Most recently, 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 Secretary of Barrett Business Services, Inc., a Nasdaq-listed business services firm, from 1994 to 2008; and Executive Vice President, Chief Financial Officer and Secretary of Sprouse-Reitz Stores Inc., a former publicly held retail company, from 1988 to 1994. He began his career with Deloitte & Touche LLP. Mr. Mulholland received a B.S. in accounting and a M.B.A. in finance from the University of Oregon. He is a certified public accountant.
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Nitya G. Ray, Ph.D. – 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.