Medical Cannabis Companies Leverage Biosynthesis to Boost Drug Development

NEW YORK, September 26, 2017 /PRNewswire/ --

Scientists have discovered more than 90 known cannabinoid compounds that may have potential to fight disease and have beneficial health effects. For biotech companies looking to harness these compounds for drug development, the challenge is two-pronged: the time consuming, expensive process of sourcing cannabinoids naturally and removing impurities, or safely and efficiently attempting chemical synthesis of compounds identical to those found in nature, a problem driven by the requirements of the FDA. InMed Pharmaceuticals, Inc. (OTC: IMLFF) (CSE: IN) (IMLFF Profile) has found a solution to these problems by utilizing the DNA of naturally occurring cannabinoids to produce, in a laboratory setting, compounds identical to those found in nature. The future of cannabinoid-based medicine hinges on such innovations which are: the ability to produce cannabinoids identical to those found in nature in a safe, consistent and economical fashion to advance cannabis-based drug development. Others active in this field are GW Pharmaceuticals PLC (NASDAQ: GWPH), Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE), 22^nd Century Group Inc. (NYSE: XXII) and Axim Biotechnologies Inc. (OTC: AXIM).

Alone or in combination, cannabinoids can fight diseases such as diabetes, Alzheimer's, depression, and even cancer. Chemical synthesis is one method tried by pharmaceutical companies exploring the health benefits of cannabinoids for their own product pipeline. However, it is difficult to synthesize compounds identical to their natural counterparts, as the slightest structural variations can affect the potential efficacy and safety of the finished product. Companies utilizing extraction methods for the cannabis plant find that planting, growing, harvesting, and extracting cannabinoids for medicinal use are time consuming, while the water, electricity and manpower needed adds to the expense. In addition, fertilizers and pesticides can be hard to remove, and crop fluctuations can affect yield. Producers are also often strained by the management of time, effort, and expense, not to mention chemical waste.

The challenges of both chemical synthesis and botanical extraction are a thing of the past for InMed Pharmaceuticals, Inc. (OTCQB: IMLFF) (CSE: IN.CN) , which has discovered a way to manufacture cannabinoid compounds in quantities and purities (above 95%) suitable for pharmaceutical use, largely eliminating previous concerns.

InMed's solutions is a biosynthesis process, utilizing the bacterium E. coli, that starts with cannabinoid DNA so compounds identical to those found in nature can be created in a controlled laboratory. Each cannabinoid can be manufactured individually, to strict purity standards, and without the need to separate individual compounds. Applicable to any of the 90+ cannabinoids, the process involves less time and cost, while a controlled environment affords a high level of quality control every step of the way. In fact, biosynthesis is part of the company's key intellectual property.

InMed recently filed a provisional patent, which will be converted to an international Patent Cooperation Treaty (PCT) application in the coming months. Upon approval, this coverage will provide InMed's E. coli-based expression system commercial protection. A series of patent applications is expected to follow, boosting the company's cannabinoid biosynthesis program, one of its three core assets that also include a drug development program (with pipeline drugs for Epidermolysis bullosa, glaucoma, and pain), and a bioinformatics assessment tool to target specific compounds for diseases.

"This novel approach to the biosynthesis of cannabinoids is a game-changer for drug development. 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," Dr. Vikramaditya Yadav, Assistant Professor of Chemical and Biological Engineering at University of British Columbia, a Co-inventor of the biosynthesis technology, stated in a news release announcing the provisional patent filing. "In our extensive experimentation, the E. coli system is more robust and more efficient for the manufacturing of cannabinoids as compared to other microbial platforms."

One could argue that InMed's biotech innovation is the next big thing since Canadian researchers discovered how to use insulin sourced from animal pancreases to replace human insulin in 1921 (http://nnw.fm/O5fHz).  

Harvesting insulin from animal organs became big business. Indianapolis, Indiana, based Eli Lilly and Company was the leader in this arena for nearly 60 years. That was until the discovery of biosynthetic insulin by Genentech, utilizing an E. coli-based system similar to InMed's. The two businesses ended up in a partnership, growing Eli Lilly into a $73 billion pharmaceutical giant.

Aside from its biosynthesis program, a considerable portion of InMed's potential centers on the fact that it has the world's leading experts to advance and commercialize the technology it has perfected. The recent addition of Ben Paterson, P.E., as a consultant is case-in-point. Paterson previously served as a senior engineering advisor with Eli Lilly and Company, where he spent 24 of his 37 years in their biosynthesis division. His expertise includes defining laboratory process and scaling them to support pilot and commercial scale development, and integrating biochemistry, equipment, and process control. Paterson is also experienced at designing, constructing, operating, optimizing, and troubleshooting large and small molecule drug facilities.

There are other biotech companies working to commercialize pharmaceutical-grade medical marijuana that passes FDA requirements. UK-based GW Pharmaceuticals PLC (NASDAQ: GWPH) is one of them. The company's lead candidate is a pure cannabidiol liquid formulation, Epidiolex® (http://nnw.fm/6gEdh), to treat childhood-onset epilepsy. A 2016 report noted it had the capacity to manufacture enough drug to treat 40,000 patients annually (http://nnw.fm/Qvu53). Savitex®, an oral mucosal spray, has been commercialized to treat individuals with multiple sclerosis, while the biotech firm has worked to explore cannabinoid molecules for treating glioma and schizophrenia.

Further demonstrating the marketability of InMed's platform is Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), which last month reported disappointing top-line results from its phase II study of ZYN002, positioned as the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Per the company's website, Zynerba's product candidates are 'synthetically manufactured per FDA/CGMP regulations' to 'provide consistent potency and eliminate impurities in the product.' Like InMed's biosynthesis platform, Zynerba's manufacturing techniques hold several advantages over botanically extracted cannabinoids, sidestepping, 'the natural resources and security measures required to grow cannabis, as well as the strict batch controls required by regulatory agencies in pharmaceutical manufacturing.'

The biotech innovations of 22^nd Century Group Inc. (NYSE: XXII) have addressed U.S. federal restrictions on THC content for hemp crops. Under U.S. law, crops having more than 0.3% THC must be destroyed, as stated on the company's website (http://nnw.fm/z2Acc). It also reveals XXII has developed zero-THC industrial hemp plants that have optimized levels of CBD, CBG, CBC, and other medically significant cannabinoids. Working with university research partners, the company is working to adapt different plants to various climates, and has exclusive rights to commercialize these plants in the U.S. It has also developed a means to genetically engineer tobacco plants to regulate the level of nicotine, among other nicotinic alkaloids, to develop smoking cessation and reduced-risk tobacco products.

Axim Biotechnologies (OTC: AXIM) has employed its cannabinoid compounds to produce MedChewRx™, a chewing gum to treat irritable bowel syndrome. MedChewRx is currently the most advanced program in the company's clinical pipeline, now in phase II trials. Phase II trials are expected to begin by early 2018. Also in Axim's clinical development pipeline (http://nnw.fm/xTs6H) are chewing gums for pain/spasticity in multiple sclerosis, nausea/vomiting/loss of appetite, and opioid addiction/dependence. A capsule for Crohn's disease is also in development.

At the core of these company's cannabis exploration is that cannabinoids have been found to have high therapeutic value while being low in toxicity, tapping into the human body's natural endocannabinoid system. The results of more than 23,000 studies have noted positive benefits, according to Medical Marijuana, Inc. (http://nnw.fm/8TJb2), and fewer barriers to drug development promise an environment favorable for growth in the world's medicinal cannabis markets. InMed is using novel techniques to develop new drugs for common diseases, by expediting the production of the more than 90 known cannabinoids. These firms are not just looking to benefit shareholders, but also patients from all walks of life.

For more information on InMed Pharmaceuticals, visit InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)

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