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) infection.
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 PRO 140, one of the leading monoclonal antibodies under development for HIV 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 experts who advise on the company's trial designs.
- Positioning in two multi-billion dollar markets
Have initiated two Phase 3 trials for HIV and one Phase 2 for non-HIV Graft vs. Host Disease (GvHD)
Primary endpoint results for a pivotal Phase 3 is expected in first quarter 2017
CytoDyn's lead product candidate, PRO 140, belongs to a new class of HIV/AIDS therapeutics intended to protect healthy cells from viral infection. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially minimum side effects or toxicity and less frequent dosing requirements, as compared to daily drug therapies currently in use.
PRO 140 Highlights:
- Candidate has been used in more than 200 HIV-infected patients in 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
PRO 140 has also demonstrated significant advantages over standard-of-care highly active antiretroviral therapy (HAART).
PRO 140 advantages vs. currently approved therapy:
- No drug resistance in patients on monotherapy for ~24 months
Viral load suspension in patients on monotherapy for ~24 months
No serious adverse events (SAEs)
No serious side effects seen in >200 patients to-date
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. – President and CEO
Dr. Nader Pourhassan became CytoDyn's managing director of Business Development in June 2011 following his tenure as COO from May 2008 to June 2011. Born in Tehran, Iran, in 1963, Dr. Pourhassan immigrated to the United States in 1977 and became a U.S. citizen in 1991. He 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. Prior to joining CytoDyn, Dr. Pourhassan was an instructor of Mechanical Engineering at The Center for Advanced Learning in Oregon, and from 2005 to 2006 was an instructor at Mount Hood Community College. Over the past 20 years, Dr. Pourhassan has also managed a family-owned export/import and manufacturing business.
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Denis R. Burger, Ph.D. – Vice Chairman and CSO
Dr. Denis Burger was appointed a CytoDyn director in February 2014, vice chairman in August 2014 and CSO in January 2016. He is a life sciences executive with over 30 years of extensive scientific, operational and financial experience in the biotech industry. As CEO or chairman of several biotechnology companies, Dr. Burger has led numerous corporate financing transactions and public securities offerings and has experience leading R&D, GMP manufacturing and clinical development functional areas. He is currently a director of Aptose Biosciences Inc., a cancer therapeutics, NASDAQ-listed company. Dr. Burger co-founded Trinity Biotech, also a NASDAQ-listed diagnostic company, in June 1992; served as its chairman from June 1992 to May 1995; and is currently lead independent director. Until March 2007, he was chairman and CEO of AVI Biopharma Inc. (now Sarepta Therapeutics), a NASDAQ-listed RNA therapeutics company. He was also a co-founder of Epitope Inc. (now Orasure Technologies, NASDAQ listed), serving as its chairman from 1981 to 1990. Dr. Burger previously held a professorship in the Department of Microbiology and Immunology and Surgery (Surgical Oncology) at the Oregon Health and Sciences University in Portland. Dr. Burger received his undergraduate degree in bacteriology and immunology from the University of California in Berkeley and his Master of Science and Ph.D. degrees in microbiology and immunology from the University of Arizona.
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Michael D. Mulholland – CFO, Treasurer and Corporate Secretary
Michael 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, 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 CFO of Nautilus, Inc., a NYSE-listed developer and marketer of fitness equipment. He previously was co-CFO 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; CFO and secretary of Barrett Business Services, Inc., a Nasdaq-listed business services firm, from 1994 to 2008; and executive vice president, CFO 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. Mulholland received a B.S. in accounting and an MBA in finance from the University of Oregon. He is a certified public accountant.
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Nitya G. Ray, Ph.D. – Senior VP – Manufacturing
Nitya G. Ray, Ph.D. joined CytoDyn in November, 2015 and is responsible for process development, manufacturing, supply chain and quality. Dr. Ray is an accomplished leader with 30 years of progressive, hands-on experience in diverse manufacturing platforms and product development, including biologics, antibody drug conjugates, engineered tissue therapeutics, small molecule and radiopharmaceutical drugs. Prior to joining CytoDyn, Dr. Ray served as senior vice president of manufacturing at Progenics Pharmaceuticals, Inc. where he was responsible for Process Sciences, Manufacturing and Quality control. Prior to that, he served as director of bioprocess development at Ortec International and held positions of increasing responsibility at Hoffmann-La Roche in the areas of GMP manufacturing and process development for engineered tissue therapeutics and biopharmaceuticals, and at Verax Corporation where he developed process technology for biopharmaceutical manufacturing. Dr. Ray received a Ph.D. and Master of Science in Chemical & Biochemical Engineering from Rutgers University and a Bachelor of Science in Chemical Engineering from Jadavpur University, India.
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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