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.
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FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment of COVID-19, especially those medicines that may provide a benefit to patients with the most severe forms of disease that can result in respiratory failure and death. Leronlimab, a monoclonal antibody investigational drug under development by CytoDyn, Inc. (CytoDyn), is one of the potential medicines that has been studied to determine whether it is safe and effective in treating patients with COVID-19, including those with severe outcomes from COVID-19.
CytoDyn has conducted two separate clinical trials investigating leronlimab for the treatment of COVID-19. A smaller trial, titled CD10, which included 86 patients, studied leronlimab’s effect on mild-to-moderate COVID-19 disease. A larger trial, titled CD12, which included 394 patients, studied leronlimab’s effect on severe symptoms of respiratory illness associated with COVID-19. CytoDyn has communicated information to the public about the results of these trials. Although FDA generally cannot disclose confidential information about unapproved products, we have concluded that given the significant public interest in leronlimab, it is important to provide summary information about the status of the CytoDyn development program.
First, we underscore the significance of a well-designed clinical trial when evaluating whether a medicine is safe and effective for a particular use. Well-designed trials have specific objectives, referred to as “endpoints”, that are documented (i.e., pre-specified) in the study protocol before the initiation of the investigation. Data obtained from the clinical trial are later analyzed using pre-specified statistical methodologies. If the analyses of the primary and secondary endpoints do not support conclusions of the medicine’s benefit, then FDA considers subgroup analyses to be exploratory, meaning they may inform the design of future trials, but do not support reliable conclusions about the medicine’s benefit. Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted.
With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints. The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo.
The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).
CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program.
FDA recognizes the critical unmet medical need for new, effective treatments for COVID-19, especially for severe forms of the disease. We are committed to working with sponsors of novel therapies to facilitate development and approval of new treatments.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT CNBC REPORTING ON THE CALL TO OUST NADER!
https://www.cnbc.com/2021/07/24/large-shareholder-group-calls-for-a-board-overhaul-at-pharma-company-cytodyn.html CYTODYN UNDER FEDERAL INVESTIGATION!!!
8/5/2021 https://www.cytodyn.com/newsroom/press-releases/detail/548/cytodyn-files-lawsuit-against-rosenbaumpatterson-activist?fbclid=IwAR2Q2j5LJfFwNwxWwi9ZRojA9sL4mT4XE1KqRQSwSft4fmAfQ6W3q_HO7Y4 Scott A. Kelly, M.D., Chairman of the Board and Chief Medical Officer of CytoDyn, said, “We are taking this step to protect the rights of all our shareholders. We believe the Rosenbaum/Patterson Group has been purposely misleading shareholders and, in the process, has violated securities laws. We are bringing this lawsuit so that we can return our full focus as quickly as possible to what matters most to our company, shareholders and patients: securing approval for leronlimab and bringing its lifesaving potential to market.”
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn. The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity.
In addition, the Company and certain of its executives have received subpoenas in connection with an investigation being conducted by the United States Department of Justice. The subpoenas seek testimony and/or records concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn.
10/26/21 Cytodyn vs Amarex court filing exhibit:
From: Nader Pourhassan <email@example.com>
Sent: Tuesday, April 14, 2020 10:49 AM
To: Kush Dhody <firstname.lastname@example.org>; Kazem Kazempour <email@example.com> Cc: Nitya Ray <firstname.lastname@example.org>
Subject: BLA submission
Dear Nitya and Kush:
Today we have so far in 1 hour almost 20% drop in our stock price. Yesterday we had drop also after putting out great results about COVID-19 patients we are seeing these type of decline.
This drop will be much deeper if we don’t file our BLA as the message board now is getting bombarded by investors who are very frustrated with me and CytoDyn.
Please file the BLA no later than next week Wednesday, even if we are short in no matter what portion of whatever it is that we are short.
Dear Nitya: Please communicate with Kush about how much time they need to prepare the CMC portion after you send it to them. Kush told me yesterday he needs one week if so, they need the CMC package tomorrow to make the next week's Wednesday deadline. Please talk to Kush to see if there is any way they could take 1-2 days to prepare the CMC portion for final filling as you and I discussed yesterday
Dear Kush: The COVID-19 is no longer CytoDyn’s top priority as if the stock continues its drift then financially we will have problems financing itself. THE MOST IMPORTANT thing now is BLA. Please focus on that urgently only.
With best regards Nader
12/21/21 Amended Class Action Complaint
EXPANDED FEDERAL INVESTIGATION
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain Company executives have received subpoenas concerning similar issues and may be interviewed by the DOJ or SEC in the future. The SEC informed the Company that its inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.
The Company is cooperating fully with these non-public, fact-finding investigations, and as of the date of this filing, the Company is unable to predict the ultimate outcome and cannot reasonably estimate the potential possible loss or range of loss, if any.
CytoDyn board of directors removes CEO - The Columbian
CytoDyn Announces Partial Clinical Hold of HIV Program and Full Clinical Hold of COVID-19 Program
VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- 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 that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.
The Company was not enrolling any new patients in the trials placed on hold in the United States. The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical hold as soon as possible. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company is not currently conducting any COVID-19 trials in the United States, as it is evaluating the most optimal programs on which to focus its resources and attention.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA. We will provide an update when we have additional information.”