InMed Pharmaceuticals Inc. (INM)

A drug discovery and development company uniquely focused on the therapeutic potential of cannabinoids

InMed Pharmaceuticals is a pre-clinical stage biopharmaceutical company that specializes in developing novel therapies through the research and development into the extensive pharmacology of cannabinoids coupled with innovative drug delivery systems.

InMed is utilizing its proprietary bioinformatics assessment tool to identify bioactive compounds within the cannabis plant that have the potential to have physiological impacts on specific diseases. The goal is to identify new drug candidates that optimize therapeutic benefit while limiting adverse effects.

InMed’s proprietary in silico drug/disease bioinformatics assessment tool, cannabinoid biosynthesis technology and drug development pipeline are the fundamental value drivers of the Company.

Investment Highlights

Bioinformatics: Proprietary Drug / Disease Targeting Tool

InMed’s has developed a computer-based program to assist in the identification of novel cannabinoids using: (i) comprehensive algorithms to integrate data from numerous bioinformatics databases, (ii) a database on the structure of currently approved pharmaceutical products, and (iii) an extensive database on over 90 individual cannabinoid drugs found in cannabis.

Protein-Protein interactions
Gene Regulation
Epigenetic modification
Cell signal networks, and
Metabolomics




InMed uses processes called “random walk algorithms” and “guilt by association” to establish gene and protein-protein interaction networks to identify multi-target based approaches for therapy development for specific diseases.

By using its comprehensive pharmaceutical and cannabinoid structures database, and by creating associations between approved pharmaceuticals (whose pharmacodynamics effects are well characterized) and cannabinoids with similar structures, InMed identifies active cannabinoids to act on above mentioned genes and proteins.

Once a series of potentially active cannabinoids are identified for a specific disease target, InMed will test and confirm their activity in biological systems with in vitro and in vivo experimentation.

This type of bioinformatics assessment, as a general approach, represents significant promise for future drug discovery, as it integrates many data sets and builds holistic models to approach a specific disease.

Biosynthesis

Most of us are familiar with the two main bio-active ingredients produced by the cannabis (marijuana) plant, namely THC and CBD. In reality, however, there are 90+ cannabinoids in the plant that could have medical value but are too hard to research due to the fact that they only appear in trace amounts in each plant. InMed has developed, patented and intends to commercialize a process for producing all 90+ cannibinoids using genetically engineered bacteria to create bioidentical copies of these substances. Not only is their process less costly but it also produces these cannabinoids in large quantities at pharmaceutical grade purity. The following link provides a clear explanation of the process in laymen's terms.
 

Biosynthesis: The Science That May Unlock the Medical Potential of Cannabis

 

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Pipeline

InMed is building a robust product pipeline through its proprietary discovery platform and research & product development programs. The company continues to seek innovative product candidates for the treatment in following therapeutic areas:

InMed's pipeline currently includes two drug candidates in preclinical development: INM-750 for the treatment of epidermolysis bullosa (EB); and INM-085 for the treatment of glaucoma.

INM-750

Referred to as "The Worst Disease You've Never Heard Of," EB is a rare genetic connective tissue disorder that affects roughly one out of every 20,000 births in the United States. Through the development of INM-750, InMed is attempting to address this significant unmet medical need, for which there is no approved treatment or cure. INM-750 replaces missing keratins in the skin with specially selected cannabinoids in an effort to modulate the painful manifestations of EB.

Market Potential - Amicus Therapeutics recently acquired Scioderm, Inc. and its lead EB drug candidate, Zorblisa™, for $847 million. Notably, Scioderm's sole clinical asset was Zorblisa.

JP Morgan and Cowen Research Reports estimate that peak sales for Zorblisa could reach $900 million to $1.2 billion.

INM-085

INM-085 is formulated to reduce the elevated intra-ocular pressure that is often associated with glaucoma. Additionally, the cannabinoids utilized in INM-085 are expected to provide neuroprotection for the retinal ganglion cells and other optic nerve tissues following topical administration. Although it is still in preclinical development, INM-085 targets a sizable market. According to the Glaucoma Research Foundation, glaucoma is a leading cause of blindness with no approved cure.

Market Potential - The National Institutes of Health estimates that more than 3 million Americans currently have glaucoma, and more than 120,000 have been blinded by the disease. Worldwide, glaucoma represents a market of $5.6 billion.

Leadership

InMed's management team has well over a century of combined experience in the biopharmaceutical space. Together, the professionals comprising this team are guiding InMed into exciting opportunities in the cannabis-pharma sector.

Eric A. Adams, President & CEO
Eric Adams is a seasoned biopharmaceutical executive with over 25 years of experience in company and capital formation, global market development, mergers & acquisitions, licensing and corporate governance. Mr. Adams previously served as CEO at enGene Inc., which he led from a nascent start-up to becoming a venture capital-backed leader in gene therapy. Prior to enGene, he held key senior roles in global market development with QLT Inc. (Vancouver), Advanced Tissues Science Inc. (La Jolla), Abbott Laboratories (Chicago), and Fresenius AG (Germany). Mr. Adams is well regarded in the Canadian biotech industry for his service as a strategic advisor to a number of early-stage biotech companies, as a previous Chairman of BIOTECanada's Emerging Company Advisory Board and for his extensive generosity in mentoring biotech entrepreneurs.

He is a dual citizen of Canada and the United States and holds a Masters of International Business from the University of South Carolina and a Bachelors in Chemistry from the University of Southern Indiana aerospace industry, most recently with Metal Form, Inc., a privately held aerospace manufacturing company, where he served as president and CEO from 1987 to September of 1999.

Dr. Sazzad Hossain, Ph.D., M.Sc., Chief Scientific Officer
Dr. Sazzad Hossain has more than 20 years of academic and industrial experience in new drug discovery, natural health product development. He was Group Leader and Senior Scientist at Biotechnology Research Institute of National Research Council Canada, Government of Canada's prime biotechnology research organization where he set up pharmacology laboratory to evaluate safety and efficacy of new drugs under development in the areas of cancer, cardiovascular and ocular diseases. Prior to joining the National Research Council Canada, he was at Xenon Pharmaceuticals in Vancouver, B.C, where was Associate Director of Pharmacology and led pharmacology teams targeting pain, inflammation and cardiovascular diseases. Dr. Hossain received his PhD in Biology from Moscow State Academy of Veterinary Medicine & Biotechnology and received post-doctoral training in the Department of Nutritional Science and Department of Medical Genetics of University of British Columbia. He was associate professor of pharmacology at Federal University of Minas Gerais, Brazil between 1988 -1996. He is the author of more than 40 peer-reviewed papers, primarily in the pharmacology, genetics and nutritional sciences.

Dr. Ado Muhammed, MD, DPM, MFPM, Chief Medical Officer
Dr. Ado Muhammed is a proven leader in the development of cannabinoid therapies, having played a strategic role in the clinical development, R&D, and commercialization of these specialty drugs. His previous position was Associate Medical Director at GW Pharmaceuticals, a UK-based Pharmaceutical Company specializing in the development of cannabinoid based prescription medicines. In this role and others at GW Pharmaceuticals, Dr. Muhammed was involved in the advanced delivery of core clinical research and was involved in key decision-making regarding R&D and product commercialization. Dr. Muhammed's received his MD at Ahmadu Bello University followed by an MSc in Orthopaedics at University College London. Dr. Muhammed achieved a DipPharMed in Pharmaceutical Medicine at University of Wales in Cardiff followed by an MBA in Business Administration at the University of Leicester. He is Member, Faculty of Pharmaceutical Medicine (Royal College of Physicians of England), the British Association of Pharmaceutical Physicians and the International Society for Pharmacovigilance.

Alexandra D.J. Mancini, M.Sc., Senior Vice President, Clinical and Regulatory Affairs
Alexandra Mancini has over 30 years' of global biopharmaceutical R&D experience with a particular emphasis on clinical development and regulatory affairs. Ms. Mancini has been an executive with several biotech companies, overseeing a wide range of drug development activities. As Sr. VP of Clinical & Regulatory Affairs at Sirius Genomics, her role included identifying and managing external resources for medical expertise in sepsis; clinical data management; and statistical theory, programming and analyses. While at INEX Pharmaceuticals as Sr. VP of Clinical & Regulatory Affairs, Ms. Mancini oversaw Clinical Research, Medical Affairs, Clinical Data Management, Medical Writing, Regulatory Affairs, and Quality Assurance for oncology. She served as VP of Regulatory Affairs at QLT Inc. for oncology and ocular diseases, playing a significant role in the development of VISUDYNER from the preclinical stage through to its approval as the first drug for age-related macular degeneration. While at QLT, Ms. Mancini also led the regulatory approval process for the anticancer drug PHOTOFRINR and its associated medical devices, the first drug-device combination product approved by the US Food and Drug Administration. Ms. Mancini has led the data analysis and assimilation, writing, submission and subsequent defense of drug submissions to regulatory agencies around the world, leading to several drug approvals and label extensions. Ms. Mancini holds a Master of Science degree from the University of Toronto. She is also a Visiting Lecturer at the Segal Graduate School of Business, Simon Fraser University.

Jeff Charpentier, CFO, Chief Financial Officer
Jeff Charpentier is a veteran of the biopharmaceutical industry with over 25 years of experience. Jeff has held a series of senior financial roles at several public and private companies in the pharmaceutical and technology sectors where he led multiple equity financings, raising in excess of $150M and concluded a number of corporate partnering/product sale transactions. Jeff previously served as CFO for Lifebank Corp. (through to successful company sale in 2012), Inex Pharmaceuticals Corporation (now Arbutus Biopharma Corp.), and Chromos Molecular Systems Inc. Jeff has a Bachelor of Commerce degree from the University of British Columbia and is a member of the Chartered Professional Accountants of BC.

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DEVELOPING NOVEL THERAPIES THROUGH RESEARCH AND DEVELOPMENT

InMed Pharmaceuticals is a pre-clinical stage biopharmaceutical company that specializes in developing therapies through the Research and Development into the extensive pharmacology of cannabinoids coupled with innovative drug delivery systems.


Corporate Presentation
https://www.inmedpharma.com/site/assets/files/1343/jan-cp-2017-2.pdf
 

PIPELINE

InMed Pharmaceuticals is currently developing two products in its drug pipeline: INM-750, for the treatment of Epidermolysis Bullosa, and INM-085, for the treatment of Glaucoma.


 

Epidermolysis Bullosa (EB) is group of inherited connective tissue diseases that share a common manifestation of extremely fragile skin that blisters or tears easily from friction or trauma. Internal organs and bodily systems can also be affected by EB. It is a result in a defect of anchoring between the dermis and epidermis cause most frequently by the absence of certain keratins (or, proteins) in the skin. EB is an orphan disease with no currently approved treatments and has a significant unmet medical need. INM-750 will potentially be the first therapy designed and developed specifically to modulate disease activity and to alleviate symptoms in EB.

INM-750 includes multiple cannabinoids as the active ingredients:

The cannabinoids included in INM-750 were selected to modulate keratin levels in patients with EB with the expectation of having a disease modulating effect
A secondary consideration in selection of the cannabinoids was addressing symptoms of EB such as inflammation, wound healing, skin regeneration, itching, and pain
INM-750 is being developed for topical application, designed to maximize penetration of the cannabinoids to the epidermal / dermal junction in the skin.

 

INM-085

Glaucoma is a group of eye disorders which result in damage of the optic nerve. The damage is most often caused by an abnormally high pressure in the eye and is one of the leading causes of blindness in the developed world.

INM-085 will be the first ever glaucoma treatment developed that is a multi-target, multi-mechanism of action therapy, utilizing multiple cannabinoids for optimal efficacy. The cannabinoids in INM-085 have been selected to reduce the elevated intra-ocular pressure (IOP) in the affected eyes and provide neuroprotection for the retinal ganglion cells (RGCs) and other optic nerve tissues.

INM-085 is designed as a topical formulation to be administered directly to the eye. The formulation that has been designed by InMed is a proprietary polymer-based formulation to facilitate absorption of the cannabinoids into the eye while also being well tolerated by the patients. We envision a once-a-day application, at bedtime, to deliver effective dose levels of INM-085.

 

AREAS OF RESEARCH

Proposed Targets to Develop Drugs From Cannabis and Other Botanical Sources

Dermatology

Epidermolysis Bullosa
Pachyonychia Congenital
Epidermolytic Ichthyosis

Pemphigus Vulgaris

Ocular

Glaucoma

 

Ocular Allergies

Pain and Inflammation

Orofacial Pain

 

Rheumatoid Arthritis

CNS

Huntington’s Disease

Epilepsy

Anti-anxiety

Respiratory

COPD

Asthma

Rhinitis

Metabolic Disease

Diabetes

Obesity

Metabolic Syndrome

Cannabis Compounds & Their Targeted Disease Areas


 

CANNABINOID SCIENCE

The majority of pharmaceutical and academic research & development activities being performed with cannabis revolves around the understanding of its biologically active ingredients, the Cannabinoids

Currently there are 90+ cannabinoids that have been isolated from cannabis, each affecting the body’s cannabinoid receptors and responsible for unique pharmacological effects.

There are three general types of cannabinoids: herbal cannabinoids which occur uniquely in the cannabis, endogenous cannabinoids produced in the bodies of humans and animals and synthetic cannabinoids produced in the laboratory.

Cannabinoid Receptors

Before the 1980s, it was often speculated that cannabinoids produced their effects through nonspecific interaction with cell membranes, instead of interacting with specific receptors. The discovery of the first cannabinoid receptors in the 1980s helped to clarify their role. These receptors are common in animals, and have been found in mammals, birds, fish and reptiles. There are currently two known types of cannabinoid receptors, called CB1 and CB2.






 

CB1 receptors are found primarily in the brain, specifically in the basal ganglia and in the limbic system, including the hippocampus. They are also found in the cerebellum and in both male and female reproductive systems. CB1 receptors are essentially absent in the medulla oblongata, the part of the brain that is responsible for respiratory and cardiovascular functions. Thus, there is not a risk of respiratory or cardiovascular failure as there is with many other drugs. CB1 receptors appear to be responsible for the euphoric and anticonvulsive effects of cannabis.

CB2 receptors are almost exclusively found in the immune system, with the greatest density in the spleen. CB2 receptors appear to be responsible for the anti-inflammatory and possibly other therapeutic effects of cannabis.

The protein sequences of these two receptors are about 45% similar. In addition, minor variations in each receptor have been identified. There is some indication that other receptors exist, but none have been confirmed. Cannabinoids bind reversibly and stereo-selectively to the cannabinoid receptors. The affinity of an individual cannabinoid to each receptor determines the effect of that cannabinoid. Cannabinoids that bind more selectively to certain receptors are more desirable for medical usage.

Herbal Cannabinoids

Herbal cannabinoids are nearly insoluble in water but soluble in lipids, alcohols and other non-polar organic solvents. All herbal cannabinoids are derived from their respective 2-carboxylic acids (2-COOH) by decarboxylation that is, catalyzed by heat, light, or alkaline conditions. Herbal cannabinoids occur naturally only in the cannabis plant, and are concentrated in a viscous resin that is produced in glandular structures known as trichomes. In addition to cannabinoids, the resin is rich in terpenes, which are largely responsible for the odor of the cannabis plant.

There are over ninety known herbal cannabinoids. Of these, tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most prevalent and have received the most attemtion. Other common cannabinoids include:

CBG	Cannabigerol
CBC	Cannabichromene
CBL	Cannabicyclol
CBN	Cannabidiol
CBV	Cannabivarol
THCV	Tetrahydrocannabivarin
CBDV	Cannabidivarin
CBCV	Cannabichromevarin
CBGV	Cannabigerovarin
CBGM	Cannabigerol Monoethyl Ether

THC is the primary psychoactive component of the plant. Medically, it appears to mediate pain and to be neuroprotective. THC has a greater affinity for the CB1 receptor than for the CB2 receptors. Its effects are perceived to be more cerebral.

CBD is not psychoactive, and appears to mediate the euphoric effect of THC. It may decrease the rate of THC clearance from the body, perhaps by interfering with the metabolism of THC in the liver. Medically, it appears to relieve convulsion, inflammation, anxiety, and nausea. CBD has a greater affinity for the CB2 receptor than for the CB1 receptor. It is perceived to have more effect on the torso than on the brain or CNS.

Cannabinoids were first discovered in the 1940s. The structure of THC was first determined in 1964. Due to molecular similarity and ease of synthetic conversion, it was originally believed that CBD was a natural precursor to THC. However, it is now known that CBD and THC are produced independently in the cannabis plant.

Cannabis plants can exhibit wide variation in the quantity and type of cannabinoids they produce. The mixture of cannabinoids produced by a plant is known as the plant’s cannabinoid profile. Selective breeding has been used to control the genetics of plants and modify the cannabinoid profile. For example, strains of hemp, which are used as fiber, are bred such that they are low in psychoactive chemicals like THC. Strains used in medicine are often bred for high CBD content, and strains used for recreational purposes are usually bred for high THC content, or for a specific chemical balance. Some strains of more than 20% THC have been created.

Cannabinoids can be administered by: smoking, vaporizing, oral ingestion, transdermal patch, intravenous injection, sublingual absorption, or rectal suppository. Once in the body, most cannabinoids are metabolized in the liver, although some is stored in fat.

Cannabinoids can be separated from the plant by extraction with organic solvents. However, to produce high purity, cannabinoid chemical synthesis or semisynthesis is generally required.

R & D PARTNERSHIPS

University of British Columbia
Department of Chemical & Biological Engineering
Vancouver Campus
2360 East Mall
Vancouver, BC Canada V6T 1Z3

Department of Pharmaceutical Sciences
Vancouver Campus
2405 Westbrook Mall
Vancouver, BC, Canada V6T 1Z3

University of Debrecen
Research Center for Molecular Medicine, Department of Physiology
1H-4032 Debrecen, Nagyerdei krt. 98
Hungary