New York, New York (NetworkNewsWire) – 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.
(CSE: IN) (OTCQB: IMLFF) (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 is: 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), 22nd Century Group Inc (NYSEMKT:
XXII) and Axim Biotechnologies Inc. (OTCQB:
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. (CSE: IN) (OTCQB: IMLFF), 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. (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 22nd Century Group Inc
(NYSEMKT: 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 (OTCQB: 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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