Company Overview:
Peer Insights Report Q&A Joel S. Ross, M.D., Scientific Founder and Chairman
PHARMACEUTICAL & DIAGNOSTIC COMPANY FOCUSED ON
EFFECTIVE TREATMENTS
FOR
ALZHEIMER’S DISEASE & INFLAMMATION
EXECUTIVE SUMMARY
INVESTMENT HIGHLIGHTS:
- Phase 1 Alzheimer’s proof-of-concept completed in 9 months and funded at a discount
- Based on latest research and may be the only effective drug targeting Alzheimer’s disease.
- Patented treatment delivery method based on data from unprecedented studies.
- Well-established, benign safety profile provide substantially de-risked path to commercialization.
- Patented drug can be effectively applied and expedited to market for many other diseases.
- Unparalleled clinical expertise and industry relationships provide highly discounted clinical and operating costs, and wide global reach.
- Team consists of leaders in commercial drug development, executive management and business strategy.
THE COMPANY: CogWellin, LLC. is a privately held diagnostic and pharmaceutical company developing the first effective biomarker and treatment for Alzheimer’s disease (AD). Founded on patented technology, CogWellin’s initial product candidate is a slow-release, once-daily pill (1) inhibiting acetyl transferase (p300) that degrades neurons and causes neurofibrillary tangles (NFTs), and (2) by treating inflammation in the brain that triggers nerve death and progressive brain damage. CogWellin will be the only drug effectively preventing neuronal damage, and based on the newest research. We expect to complete this study in the by the end of 2017.
The Company’s is simultaneously partnered with Northwestern’s Klein Lab investigating an innovative biomarker for diagnosing Alzheimer’s disease. Alzheimer’s disease is not easily or correctly diagnosed often, and the latest research has uncovered a new precursor for the disease, which may not only detect the disease in an earlier stage of life, but also great expand the potential market for CogWellin’s Alzheimer’s drug.
The active compound used in CogWellin’s phase 1 candidate is a well-known anti-inflammatory agent. With the same patented delivery method, this drug becomes a viable treatment for not only 20+ tau-protein based memory disorders, but also for various diseases characterized by inflammation, including Arthritis and Inflammatory Bowel Syndrome. Arthritis and Inflammatory Bowel Syndrome affects more than 55 million people in total in the nation, and is currently treated by aspirin, which can cause deadly side effects. In this advantageous situation, CogWellin can directly propose a phase 2 trial for both inflammatory disorders, and reach the market within 1-2 years of funding.
PLANNED PIPELINE:
COGWELLIN is a patented delivery method for salsalate (which breaks down into salicylic acid), which the United States Food and Drug Administration (FDA) has previously approved for many non-CNS indications. The previously approved dosing and delivery of these molecules is ineffective for AD treatment due to its low blood concentration availability. Our patented formulation and delivery method, improves blood and brain access of salicylic acid for inhibition of acetylated tau (Ac-tau). The efficacy of salicylic acid in animal models in the latest research support CogWellin’s mechanism of action and utility, demonstrating that our drug counters the complex neurodegeneration process associated with Alzheimer’s disease and other tau-related disorders.
Salicylic acid is commonly available and known safe anti-inflammatory agent, and may be viable to treat other tau-related disorders. The patented method increases the long-term efficacy of the active compound, which gives CogWellin the potential for treating several diseases, which all can be fast-tracked to the market due to the previous approval of this compound.
INTELLECTUAL PROPERTY:
As of December 2016, the patent for the formulation and use of slow release salsalate has been approved and the patent for the acetylated tau biomarker has been submitted.
WORLDCLASS SCIENTIFIC TEAM AND ADVISORS: CogWellin is comprised of world-class executives, advisors and scientists who are credited with extensive clinical expertise and development in the field of Alzheimer’s disease. A highly experienced core team at the Company, together with knowledgeable scientific advisory board, bring depth of product development expertise for execution of the Company’s clinical development plan, and navigation of manufacturing, quality, regulatory and commercialization hurdles.
MANAGEMENT
In Attendance:
Joel S. Ross, M.D., Scientific Founder and Chairman
In addition to being the Founder, President and Chairman of CogWellin Pharmaceuticals, Dr. Ross has had academic appointments in his medical career at Mt. Sinai Medical Center, New York NY, Hahnemann Medical School, Philadelphia Pa, UMDNJ-SOM in Stratford NJ. He is a world renowned principal investigator having conducted all five of the pivotal Alzheimer’s disease clinical trials that resulted in approval and marketing of the five FDA approved Alzheimer’s Disease medications. He has published a “primer” internationally used and “gold standard” for proper conducting of Alzheimer’s Disease. He has consulted with the world’s largest pharmaceutical companies in designing and implementing Alzheimer’s Disease clinical studies from first in man (phase I) to phase IV (post marketing studies). He has helped launch such drugs as Exelon and Namenda. He has authored many articles in the field of AD in peer reviewed journals. Dr. Ross is familiar with all aspects of drug development, testing, and commercialization.
He holds a BA in Biology from Hofstra University, Medical Degree from Downstate Medical Center, and completed a most prestigious geriatric fellowship at Mt. Sinai Medical Center. He has received numerous awards such as “Top Doctor” and humanitarian of the year award.
Mark Ornstein, M.D. VP, Principal Investigator
Mark Ornstein was personally trained over many years to take of the role of principal investigator for the majority of AD studies being conducted at the Memory Enhancement Center. He is considered by big pharma as a valued “key opinion leader” in the field of AD clinical research. His high enrollment in all AD studies combined with impeccable data produced places him at the top of the list of most valuable investigators in the AD field.
Fred Werner, Business Advisor
Mr. Frederick W. Werner has been the Group President of Design & Consulting Services at AECOM since October 2014. Mr. Werner served as the Chief Growth Officer and President of Europe-Middle East-Africa at AECOM Technology Corporation and served as its President of Corporate Development since October 2011. Mr. Werner served as Executive Vice President of Business Lines at AECOM Technology Corporation from January 2009 to September 2011. He served as Chief Executive Officer of US Transportation Group of Aecom Technology Corporation from January 2008 to January 2009 and served as its Group Chief Executive of U.S. Infrastructure Group from 2005 to 2008. Mr. Werner served as President and Chief Operating Officer of AECOM’s DMJM+Harris operation from 2003 to 2005. He began his DMJM+Harris career in the Geotechnical Division in 1977, progressing to Vice President and Manager of New Jersey Operations, Senior Vice President and Manager of New York Operations and, finally, to Chief Operating Officer before becoming President. He is passionately involved in CogWellin as a founding investor dedicated to put an end to Alzheimer’s Disease.
James Liao, Investor Relations
James Liao has been a startup consultant and advisor for more than 6 years. He currently works as an advisor in early-stage strategy and investor relations for healthcare startups, and has experience as a founder, mentor, and investor. He worked as an investment associate for 37 Angels and Bowery Capital, focusing on B2B IT SaaS investments, and has been a mentor for the Founder Institute for the last 2 years. James also held roles as an investment banker and as a hedge fund analyst, after working at Intel as a hardware engineer. He graduated with an M.B.A. from Columbia Business School, and with a B.S. in Electrical Engineering and Computer Science from University of California Berkeley. He joins CogWellin as an early-stage advisor and investor relations consultant.
William Klein Ph.D., Scientific Advisor and Academic Partner: (represented by Erica Cline)
Bill Klein is the founder and director of The Klein Lab in Northwestern University. It is a leading neurobiology research facility at the Weinberg College of Arts and Sciences, located on the campus of Northwestern University in Evanston, Illinois. Internationally-acclaimed discoveries at the Klein Lab have dramatically altered the landscape of Alzheimer’s disease research and now provide a new basis for hope. He and his lab are dedicated to discovering the cause and developing a cure for Alzheimer’s disease. To help meet these goals, we collaborate with other research teams around the globe. This includes CogWellin Pharmaceuticals, which has convinced Dr. Klein to “retool” his lab to now focus on identifying and quantifying the amount of Ac-Tau that is in the cerebrospinal fluid and other bodily fluids in AD patients versus age-matched controls. He and his lab team have written and received many NIH/NIA federal grants to help continue their ground breaking work in AD. Additionally, Dr. Klein founded Acumen Pharmaceutical, a company devoted to better detection and treatment of Alzheimer’s Disease. Acumen was founded based on the discovery of soluble Aβ oligomers and their memory compromising ability by founding scientists William Klein, Grant Kraft (Northwestern University) and Caleb Finch (U. Southern California). He believes, “Now, more than ever, there is real promise of early detection and treatment.”
Joseph D’Souza Ph.D, Scientific Advisor, Clinical Development
Dr. D’Souza is a Senior Health Care Executive with a strong background in Clinical Development and Medical Affairs. Dr. D’Souza has over 30 years of experience in the Pharmaceutical Industry where he has made a significant contribution for the treatment of patients with debilitating diseases in areas such as cardiovascular, central nervous system and gastrointestinal system disorders. Dr. D’Souza has been responsible for the global clinical development of pharmaceuticals and has participated effectively in International Global Teams and has experience in interactions with Regulatory Health Authorities Dr. D’Souza is an active member of numerous committees and professional medical associations. He has made presentations at various professional meetings, invited as a panelist at several meetings and actively participated at Advisory Board meetings. Additionally, Dr. D’Souza has authored more than 100 scientific publications. He has been successful in developing compounds that were FDA approved and resulted in over one billion dollars in sales. After obtaining his honors degree in Biological Chemistry from the University of Essex, England, Dr. D’Souza completed his doctoral thesis at St. Mary’s Hospital Medical School at the University of London. He then pursued a post-doctoral fellowship in Clinical Pharmacology at McGill University, Montreal, Canada. Joseph contributes a wealth of clinical development expertise to CogWellin as a member of its scientific advisory board.
Daniel Klessig, M.D., Scientific Advisor, Pharmacology
Dr. Klessig’s early research career, which started as a graduate student with Nobel Laureate James Watson, focused on the molecular biology of human adenovirus. His studies of this DNA tumor virus resulted in a molecular explanation for the failure of pharmaceutical companies to produce adenovirus vaccines in monkey cells in the 1950s. This work also provided some of the first evidence for split genes and led him to propose in 1977 that mRNAs Klessig – – 22 in animals are produced by a process of RNA splicing (intra-molecular ligation). Richard Roberts, with whom Dr Klessig worked, and Phillip Sharp were awarded the Nobel Prize in Physiology and Medicine in 1993 for the discovery of split genes and RNA splicing. While continuing to study adenoviruses until 1996, he initiated a research program in plant molecular biology in the early 1980’s. The goal of his ongoing research is to understand how plants protect themselves against microbial pathogens. Over the past decades he and his research team identified components in pathways, which enable plants to recognize that they are being attacked in order for them to rapidly mount defenses against the invader. Their efforts resulted in the identification of two critical defense-signaling molecules in plants – salicylic acid (SA) and nitric oxide (NO). Interestingly, both SA and NO also play roles in human health. NO is a potent endogenous signaling molecule in human, where it plays critical roles in inflammatory and immune responses, in neural transmission, and in muscle physiology. Dr Klessig’s work demonstrated that several critical players of animal NO signaling are also operative in plants during their response to pathogen assault. In 1990s Klessig and coworkers discovered the importance of SA in plants by demonstrating that it is a hormone produced by plants to activate their immune systems. Their subsequent studies identified a long-sought mobile signal for development of a state of heightened defense, which is activated throughout a plant after an initial infection, called systemic acquired resistance. This signal is methyl salicylate, a modified and inactive form of SA. Their research also revealed that, in contrast to most hormones in plants and animals, SA acts through many different protein targets to mediate its many effects on immunity and other plant processes. Interestingly, derivatives of SA, including aspirin (acetyl SA), have been used by humans for thousands of years to treat a variety of maladies. The prevailing view in the biomedical community has been that aspirin, the most widely use drug worldwide for over a century, works primarily, if not exclusively, by irreversibly inhibiting the enzymatic activities of cyclooxygenases 1 and 2 (COX1 and COX2), However, aspirin is rapidly converted in the body to SA, which has similar pharmacological effects as aspirin, despite its poor ability to inhibit the cyclooxygenases. Klessig’s recent studies are addressing this conundrum by revealing several novel targets through which SA mediates its many pharmacological effects. These targets include Glyceraldehyde 3-Dehydrogenase (GAPDH) and High Mobility Group Box1 (HMGB1). HMGB1, when released outside of cells following tissue injury or secretion by certain immune or cancer cells, has potent pro-inflammatory activities associated with rheumatoid arthritis, atherosclerosis, inflammatory bowel disease, lupus, sepsis, inflammation-associated cancers such as colorectal and mesothelioma cancers, and Alzheimer’s disease. GAPDH facilitates infection by the hepatitis viruses and is a major suspect in the neurodegenerative diseases Alzheimer’s, Parkinson’s, and Huntington’s. SA binds to both, thereby inhibiting their disease associated activities. The identification of synthetic and natural derivatives of SA, which are 40- 70 times more potent inhibitors of GAPDH’s cell death-associated activities and HMGB1’s pro-inflammatory activities than SA provides proof-of-concept that better SA-based drugs can be obtained. Dr. Klessig owns several patents related to the salicylate family of hormones. He serves also a vital role in expanding our pipeline/portfolio of newer salicylate derivatives to treat AD and other diseases. He received his B.S. at the University of Wisconsin – Madison in 1971 in Biochemistry. At the University of Edinburgh, he earned his B.Sc. Honours in 1973. In 1978, he received his Ph.D. in Molecular Biology at Harvard University Biochemistry & Molecular Biology. At Cold Spring Harbor Laboratory, he completed postdoctoral studies in 1978 in Virology. He joined CogWellin as a scientific advisor to bring long-acting once-daily CogWellin to the market as well as test his other patented salicylated formulations.
Not Attending:
Peter Davies, Ph.D., Scientific Advisor
Peter Davies was a post-doctoral fellow in the Department of Pharmacology at the University of Edinburgh, Scotland, before joining the staff of the Medical Research Council Brain Metabolism Unit in Edinburgh in 1974, where he began his research on Alzheimer’s disease. Dr. Davies’ early work was instrumental in the development of the currently approved drugs for Alzheimer’s disease — Aricept, Exelon and Razodyne. In 1977, he moved to Albert Einstein College of Medicine in the Bronx, NY, where he was a professor in the departments of pathology and neuroscience. Dr. Davies became the Scientific Director of the Litwin/Zucker Center for Research on Alzheimer’s Disease at Northwell Health’s Feinstein Institute for Medical Research in 2006. For more than 35 years, Dr. Davies’ research has been focused on biochemistry of Alzheimer’s disease. He has published over 250 research papers and has been particularly interested in the development of new treatments and diagnostic tests for Alzheimer’s disease. He has received numerous awards for his research, including the City of New York Liberty Medal, a Lifetime Achievement Award from the International Congress on Alzheimer’s Disease (ICAD) and the first Metropolitan Life Foundation Prize. Dr Davies has also received two MERIT awards from the National Institutes of Health (NIMH, 1989-1999, and NIA 2003-2013. Peter Davies received both a B.S. and a Ph.D. in Biochemistry from the University of Leeds, England.
Dr. Davies joined the board of scientific advisors of CogWellin as he believes it is important to search for the true toxin such as Ac-Tau that might be responsible for the deadly disease, Alzheimer’s.
Bruce Rehlaender Ph.D., Scientific Advisor
Bruce has over 25 years of experience in the field of pharmaceutical sciences and more specifically in the discipline of formulation sciences. His expertise extends to several tangential disciplines, including physical chemistry, pharmacokinetics, cell biology, immunology, gastrointestinal physiology, all of which impact the delivery and disposition of an active molecule from a dosage form. He has developed a broad range of dosage forms, including parenterals, oral immediate release and modified release tablets and capsules, oral liquids, topicals, and inhalation products (nasal sprays, nebulizer formulations, and dry-powder inhalers). Additionally, he has worked extensively with small molecules and with macromolecules. He received his B.A. from the University of California, Berkeley in 1983 in Biochemistry and his Ph.D. in Pharmaceutics at the University of North Carolina, Chapel in 2000. Bruce joined CogWellin as a consultant to assist in the submission of provisionally patented formulations of long-acting once-daily salsalate (known as “CogWellin”). He has embraced this molecular approach to rid the brain of the poisonous Ac-Tau and serves as a vital member of CogWellin’s scientific board of advisors.
Frank Meshowski, Business Advisor
Frank Meshowski is a personal friend of Dr. Ross and his decades of business leadership has resulted in becoming a Project manager Curtiss Wright, Woodridge, New Jersey, as early as 1952-1959. He then became Vice president sales/marketing at Gulton Industries, Metuchen, 1959-1968. Promoted to Senior vice president Nytronics, Inc., Alpha, 1968-1972, he then became a Vice President of marketing at Gulf & Western Industries, New York City, 1972-1979. He was promoted to President and Chief Executive Officer at Unicord, a division of Gulf & Western Industries, Westbury, New York, 1979-1987. He also became the Executive Vice President, Chief Operating Officer, director OPT Industries, Phillipsburg, New Jersey, 1987-1989. He now serves as a valued business consultant strategic planning, marketing and distribution, since 1989. He brings an unparalleled amount of experience in scaling companies to their maximum potential, and is most excited to be part of the business team of CogWellin.
Edward Whelan, Business Advisor
Edward T. Whelan is an experienced business executive and entrepreneur who has led diverse companies in the supply, financial and pharmaceutical industries. Currently Whelan is responsible for driving growth of BioElectronics Corporation globally by seeking out and developing new business opportunities for the company’s breakthrough technology. Prior to joining BioElectronics, Whelan served as Chairman and Chief Executive Officer of Military Resale Group, Inc. He negotiated and financed the acquisition of a private company with revenue of $750,000, and completed its reverse merger into a publicly traded company guided it through a twelve-fold growth of revenues which increased to just under $10 million. Additionally, Mr. Whelan served as the President and a principal stockholder of Xcel Associates, Inc., a company engaged in providing financial consulting to small and medium-sized companies, and to high net worth individuals. Furthermore, Mr. Whelan served as President and a principal shareholder of Shannon Investments, Inc., a consulting firm to small and medium-sized companies. From 1984 to 1989 Mr. Whelan was a co-founder of Physicians Pharmaceutical Services, Inc., a publicly traded company that made the Inc. Magazine’s fastest growing companies in America list.
Murali Duvvuri, Ph.D., Scientific Advisor
Murali joined PharmaDirections, Inc. April 2014 and is the present Cary, NC Director. He conducts Product Development (CMC), drug product development (solid orals, non-sterile liquids, inhalation – nebulized & nasal, parenterals, topical), development of early prototypes, Phase 1/Phase 2 POC formulations, formulations for late stage clinical and commercial. In addition, he is responsible for oversight of CTM manufacturing, predictive pharmacokinetic modeling using GastroPlus™, management of API development, discovery, route scouting, early development, scale-up, Tox supplies, and cGMP supplies. Other duties include designing and managing ‘Druggability’ studies for lead selection and to support lead optimization, preparation of CMC-related documents for regulatory submission, such as the pre-IND briefing book, IND/IMPD. He received his Ph.D. in Pharmaceutical Sciences in 2005 from the University of North Carolina at Chapel Hill: “Influence of the physico-chemical properties of weak bases with their intracellular distribution profiles” under the guidance of Dr. Jeff Krise. He joined the scientific board of CogWellin to further advance the production of CogWellin for human testing and maintain the highest of quality standards throughout the entire production processing.
Judith Kelleher-Andersson Ph.D., Scientific Advisor
Judith is the founder, President and Chief Executive Officer (CEO) of Neuronascent. Dr. Kelleher-Andersson has over twenty years of experience discovering and developing small molecule, central nervous system therapeutics in the biotechnology industry. At Neuronascent she discovered and developed a first-in-class neuron regenerative therapeutic that is now patented and has competed all GLP safety testing. She has raised equity and grant support to complete the GMP manufacturing and bring the lead to IND application. Prior to founding Neuronascent, Inc, she was Director of Drug Development and Research at Neuralstem, Inc., at Centaur Pharmaceuticals and at Cortex Pharmaceuticals, Inc. She strategically directed R&D and personnel toward finding innovative therapies for neurological indications with large unmet need. She headed the Alzheimer’s disease program in collaboration with Astra-Zeneca while at Centaur, and successfully brought a small molecule therapeutic to pre-nomination status (primary inventor). She invented a neurogenic depression therapeutic, while at Neuralstem, that is presently in Phase 2 clinical testing. Dr. Kelleher-Andersson has over 70 US, European and World patents. She received her Ph.D. in biochemistry from the University of Missouri-Columbia and completed post-graduate work at University of California Los Angeles and at University of California, San Francisco. Dr. Ross has been a board member of her pharmaceutical company for over ten years and she brings a great deal of expertise in early pharmaceutical development to CogWellin’s board of scientific advisors.
Quentin Florence Ph.D., Scientific Advisor
Dr. Florence has over 10 years of experience in the biotechnology industry with roles in scientific and business development. For the last 5 years, Dr. Florence has been focused on the evolution, quality testing, and manufacturing of Alzheimer’s related research products including but not limited to proteins/peptides, antibodies, and analysis kits. He strategically directed his teams in the production of novel research tools that can be used in the development of therapeutics which target neurodegenerative diseases. This work has led to the filing of 2 patents within the last year. He has overseen market research, product manufacturing, technology transfer, customer relations, research and development as well as other administrative and scientific activities. Most recently, Dr. Florence has led a team which increased the value of a privately held company by implementing organizational, marketing, and developmental changes. In addition, Dr. Quentin Florence is a founding partner of KonQuest Capital, a biotechnology focused equity firm. Quentin has consulted with Dr. Ross for the development of a valid biomarker of Ac-Tau in the CSF and other bodily fluids. He has a B.S. and Ph.D. in Biochemistry and Molecular Biology from the University of Georgia. He joined CogWellin’s board of scientific advisors as he has embraced the concept of ac-Tau as being a very early pathological event that can be possibly reversed with CogWellin’s long- acting salsalate.
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