Cannabinoid Biosynthesis Poised as Potential Game-Changer in Drug Development

NEW YORK, September 28, 2017 /PRNewswire/ --

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As the marijuana market continues its widespread growth, researchers remain merely at the threshold of exploring the manifold potential medical applications of cannabis. At present, more than 90 individual cannabinoid compounds have been discovered within the cannabis plant-each one potentially possessing crucial disease-fighting properties either on its own or combined with other compounds. Historically, however, it has been incredibly difficult to extract most of these compounds from the marijuana plant in adequate quantities and purities to be tested pharmaceutically. Overcoming this stumbling block in medical cannabis advancement, Vancouver-based biopharmaceutical company InMed Pharmaceuticals, Inc. (OTC: IMLFF) (CSE: IN) (IMLFF Profile) has developed a pioneering, high-yield biosynthesis process that enables the manufacture of all 90+ naturally occurring cannabinoids. This groundbreaking development could have an enormous impact in forwarding the efforts of other companies within the cannabis sector, including GW Pharmaceuticals (NASDAQ: GWPH), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Axim Biotechnologies, Inc. (OTC: AXIM) and 22nd Century Group, Inc. (NYSE: XXII).

InMed Pharmaceuticals, Inc.'s (OTCQB: IMLFF) (CSE: IN) novel approach to cannabinoid biosynthesis represents a potentially game-changing breakthrough in drug development. Many efforts by other companies to develop synthetic cannabis derivatives have failed. In comparison with other microbial platforms, InMed's E. coli system has proven, through substantial experimentation, to be heartier and more efficient for the manufacturing of cannabinoids.

The process of naturally sourcing most cannabinoid compounds from the cannabis plant is extremely time-consuming, involving the tasks of planting, growing, harvesting and extracting. It is also very costly; can be low-yielding because of crop fluctuations; and involves various hard-to-remove impurities like pesticides, herbicides and fertilizers. Additionally, this process yields only two to three cannabinoids that can reach adequate quantities to justify the process; the remaining cannabinoid compounds are only yielded in trace amounts and are not accessible through natural sources.

While many have tried to chemically synthesize these compounds for pharmaceutical use, the chief problem with such an approach is it is usually very hard to derive cannabis compounds that are identical to the ones that occur naturally. Slight variations in structure can change both the effectiveness and safety of these compounds. The difficulty, tedium, costliness and time-consuming nature of the process is, overall, off-putting and creates a great deal of chemical waste.

The proprietary cannabinoid manufacturing process pioneered by InMed addresses this problem through biosynthesis, which is the process of utilizing naturally occurring cannabinoid DNA to produce cannabinoid compounds in a laboratory setting. The advantages of this process are multifold, resulting in:

• Compounds that are identical to naturally occurring cannabinoids
• Pure, individual cannabinoids that can be manufactured without the necessity of separating the many compounds from one another
• A time- and cost-effective process
• High quality control throughout the process thanks to production in a laboratory setting
• The capability for all 90+ cannabinoids to be manufactured for the same reasonable cost

InMed is thus able to tap into the enormous medical potential of every cannabinoid, in particular the minor ones, due to this ability to access them in an economically sound way. The financial and time-consuming nature of other biosynthesis methods continue to pose stumbling blocks for other pharmaceutical companies.

Recently, InMed announced the filing of a provisional patent application-the first of many-relating to this proprietary biosynthesis program for manufacturing cannabinoids (http://nnw.fm/Z30dH). Once converted into an international Patent Cooperation Treaty (PCT) application and pursued in key jurisdictions on a global scale, this first patent application will give InMed significant commercial protection for its biosynthesis program, which is an E. coli-based expression system. This series of patent applications will particularly focus on the superiority of E. coli-based expression systems in comparison to other approaches; maximizing production of cannabinoids and related compounds through gene optimization; and additional proprietary developments and data related to InMed's breakthrough biosynthesis program. Over time, InMed intends to actively convert this first patent filing, along with subsequent provisional patents, into national-stage filings in every major commercial jurisdiction.

InMed's revolutionary cannabinoid biosynthesis program is one of three core assets for the company. The other two are a bioinformatics assessment tool that targets specific cannabinoids in treating key diseases and a drug development program that includes INM-750 for Epidermolysis bullosa and INM-085 for glaucoma.

InMed is assembling a strong management team to bring its biosynthesis program to commercialization. This team includes Ben Paterson, P.E., whose consulting services were recently retained by InMed (http://nnw.fm/vx1Bo). Paterson previously served as a senior engineering advisor for Eli Lilly and Company, spending 24 years in that company's biosynthesis division. His extensive expertise will help InMed transition from pilot-scale to commercial-scale manufacturing.

The company's management team also includes president and CEO Eric A. Adams, who is a veteran biopharmaceutical executive with extensive experience in company and capital formation, global market development, mergers and acquisitions, and licensing and corporate governance; Chief Scientific Officer Dr. Sazzad Hossain, Ph.D., M.Sc., who has more than two decades of academic and industrial experience in new drug discovery and natural health product development; Chief Medical Officer Dr. Ado Muhammed, MD, DPM, MFPM, who is a proven leader in developing cannabinoid therapies; Alexandra D.J. Mancini, M.Sc., who serves as the senior vice president of clinical and regulatory affairs and possesses more than 30 years of global biopharmaceutical R&D experience, with emphasis in clinical development and regulatory affairs; and CFO Jeff Charpentier, who is a biopharmaceutical industry veteran with more than 25 years of experience.

InMed's breakthrough approach to cannabinoid biosynthesis has enormous potential in helping other companies in their cannabis-related drug development efforts-companies like GW Pharmaceuticals (NASDAQ: GWPH), the company behind the world's first prescription drug derived from the cannabis plant, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis. GWPH's lead cannabinoid product candidate is Epidiolex®, a liquid formulation of pure plant-derived cannabidiol being developed for the treatment of a number of rare childhood-onset epilepsy disorders. Other companies include Zynerba Pharmaceuticals (NASDAQ: ZYNE), whose product candidates are "synthetically manufactured per FDA/CGMP regulations" in an effort to "provide consistent potency and eliminate impurities in the product"; Axim Biotechnologies (OTCQB: AXIM), which is developing a clinical pipeline of cannabinoid-based products such as its MedChewRx™ chewing gum for the treatment of irritable bowel syndrome; and 22nd Century Group (NYSE: XXII), a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The availability of all 90+ cannabinoid compounds enabled by InMed's process could mean the difference between success and failure in the development of drugs to treat various key diseases.

"This novel approach to the biosynthesis of cannabinoids is a game-changer for drug development," said Dr. Vikramaditya Yadav, assistant professor of Chemical and Biological Engineering at the University of British Columbia and a co-inventor of InMed's biosynthesis technology (http://nnw.fm/Z30dH). "The importance of producing cannabinoids that are identical to the naturally occurring compounds cannot be overstated. Many drug development efforts with synthetic derivatives have failed."

With roadways opening up in cannabinoid research and this pioneering new access to every cannabinoid compound rather than just a few of them, the potential is virtually limitless as companies like those named pursue drug development activities within the medical cannabis field. There is no telling what breakthrough cures and treatments may emerge as a result, but it is indeed an exciting time in the burgeoning cannabis space.

For more information on InMed Pharmaceuticals, please visit:

 InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)

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