CytoDyn Inc. (CYDY) is a Vancouver, Washington-based biotechnology company engaged in the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV-1) infection, GvHD and multiple Cancer types.
Monoclonal antibodies – soluble proteins produced by the body in response to infections from bacteria, viruses and other pathogens – have become one of the fastest expanding opportunities in the biotech/pharma sector. CytoDyn's lead drug candidate is Leronlimab (PRO 140), one of the leading monoclonal antibodies under development for HIV-1 infection.
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.
- 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 within 2Q19 - 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 400 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).
Leronlimab (PRO 140) advantages vs. currently approved therapy:
Leronlimab (PRO 140)
- No drug resistance in patients on monotherapy for ~36 months
Viral load suspension in patients on monotherapy for ~36 months
No serious side effect and no adverse events (SAEs) in > 400 patients in 8 clinical trial
No negative impact on immune function
- 76% of patients have resistance to 1 or more drugs
Lifelong adherence with only 30% of patients achieving suppressed viral load
Toxicity ranges from mild to life threatening
Numerous side effects
Incomplete recovery of immune function
Ongoing Clinical Trials
CytoDyn has received FDA clearance for and currently has two Phase 3 clinical trials underway. The company's first Phase 3 trial is a pivotal trial with PRO 140 in combination with current standard-of-care antiretroviral therapy (ART) for highly treatment-experienced patients with HIV. This 25-week trial involves only 30 patients with a primary endpoint of just one week of efficacy and the company expects to report primary endpoint results as early as the first quarter of 2017.
The company's other Phase 3 trial is with PRO 140 as a single-agent maintenance therapy in virally suppressed subjects with HIV. This multicenter, open-label trial is enrolling 300 patients prequalified with CCR5-tropic HIV-1 infection who are clinically stable on standard-of-care highly active antiretroviral therapy (HAART). The objective of the trial is to assess the efficacy, safety and tolerability of PRO 140 as a long-acting, single-agent maintenance therapy for the chronic suppression of HIV. Patients enrolled in the trial will be shifted from daily HAART regimens to weekly PRO 140 subcutaneous injections for 48 weeks. This trial protocol is nearly a duplicate of the Phase 2b monotherapy trial, which is ongoing with an extension study that supports a group of patients who have maintained viral suppression for over two years and is continuing.
Additionally, the company has underway a Phase 2 trial to evaluate PRO 140 for Graft vs. Host Disease (GvHD) in a 100-day study involving 60 patients. GvHD is a life-threatening complication for cancer patients undergoing stem cell transplants. This trial will evaluate the safety and efficacy of PRO 140 for prophylaxis of acute GvHD in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem-cell transplantation.
The Science of Monoclonal Antibodies
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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Richard Pestell, MD, PhD, MBA, FACP, FRS of Medicine, FRACP - Vice Chairman, Chief Medical Officer
Richard is clinician and researcher, who conducted clinical training in oncology and endocrinology. Dr Pestell's postdoctoral research was conducted at the Harvard School of Medicine and Massachusetts General Hospital (1991-1993). Dr Pestell holds a medical degree from the University of Western Australia, and an MD and Ph.D. from the University of Melbourne. He was inducted as a Fellow of the Royal Australian College of Physician, Fellow of the American College of Physicians and Fellow of the Royal Society of Medicine.
His past roles include Executive Vice President at Thomas Jefferson University (TJU has a $5.2B USD annual budget, 22,000 employees, and is located in Philadelphia USA). He was chairman of the Department of Oncology at Georgetown University and Associate Vice President of the Medical Center. As Director of the Sidney Kimmel Cancer Center (2005-2015) and Director of the Lombardi Cancer Center, Georgetown University (2002-2005) he was responsible for the oncology service line and oncology clinical trials and the interface with BioPharma.
He has received >$83M in research grant funding, has more than 700 published works including 44 book chapters, and reviews, is ranked in the world by Google Scholar (#1 cell cycle, #1 prostate cancer, #6 oncology) and received awards for his research discoveries (elected membership to ASCI (American Society of Clinical Investigation), Elected Member, Royal Society of Medicine, the RD Wright Medallion, Elected Fellow, American Association for the Advancement of Science, the Eric Susman Prize in Medicine, Advance Global Australian Award (Biotechnology), a Doctor of Medical Sciences, Honoris Causa, from the University of Melbourne, and awards from Susan G. Komen (Light of Life award, Jamie Brooke Lieberman Award).
Richard is a highly experienced Board Member and Executive with more than 20 years of experience in complex academic medical organizations. He has served on the advisory boards of USA National Cancer Institute-designated Cancer Centers, research institutes and foundations and international research institutes. Based upon his multiple issued patents, Richard was Founder and CEO of ProstaGene (sold to CytoDyn) and LightSeed.
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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.
1111 Main St.
Vancouver, WA 98660
Phone: (360) 980-8524
1324 Lexington Ave.
New York, NY 10128
Phone: (212) 418-1217
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