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5 Most Promising Companies Riding the Waves of Change in the CDB Biotechnology Space

20 Aug 5 Most Promising Companies Riding the Waves of Change in the CDB Biotechnology Space

The Cannabis plant has an estimated 113 different compounds, out of which THC and CBD are the two main constituents. These affect the receptors in the brain to alter an individual’s physical and mental state. THC is mainly responsible for the psychoactive effects or the feeling of “high” caused by the use of cannabis. CBD on the other hand, has several powerful anti-inflammatory, analgesic, neuroprotective and anti-anxiety properties, which explains its growing popularity to treat a plethora of medical conditions. Unlike THC, CBD does not have any psychotropic effects and hence is widely preferred.

CBD is now being used to treat a wide array of medical conditions such as cancer, cardiovascular anomalies, arthritis, anxiety, depression and Insomnia. In addition, it has also been proven to possess neuroprotective benefits that can treat diseases such as seizures, Multiple Sclerosis (MS), Alzheimer’s, Parkinson’s and Schizophrenia to name a few. There is a growing preference for CBD over traditional pharmaceutical options as these have minimal side effects and are non-addictive.

In 2017, The WHO expert committee on Drug Dependence (ECDD) concluded  that in its unadulterated form, CBD does not cause harm or have abuse potential. While further research is underway on the subject it has been proved that CBD is well tolerated in humans and is safe.

survey conducted by Brightfield group shows that 42% of CBD users ditched traditional medicine and a significant 80% of the CBD users rated these alternate medicine as extremely effective treatment. The same survey reveals that 90% of CBD users were likely to buy these products again. Those numbers sound the death knell for pharmaceutical companies.

The Global legal marijuana market is likely to reach over USD 66.3 billion by the end of 2025, as per a report by Grand View Research, Inc, growing at a CAGR of 23.9%. There is a growing acceptance of the curative effects of cannabis, with some countries such as Canada and certain states of U.S legalizing the use of Marijuana for medical and recreational use. Research has time and again shown that cannabinoids (CBD), extracted from the cannabis plant, have varied medical uses with minimal side effects, making it a sought after alternative to traditional pharmaceutical options.

According to statistics published in the Hemp Business Journal, the industry registered sales of $820 million in 2017. In spite of facing regulatory hurdles and legal challenges, the industry grew by 16%.

The industry is poised to grow to $2.1 billion by 2020, a whopping 700% increase from 2016. Those numbers are not only appealing to the players in the CBD market but also serve as an incredible opportunity the pharmaceutical companies to create novel solutions for disease with large unmet medical needs. We take a look at 5 Companies that are leading the bandwagon when it comes to innovation in the Cannabinoid-based medication market.

CV Sciences, Inc (OTCQB: CVSI)

Market Cap: $313.58M; Current Share Price: 3.16 USDChart
Data by YCharts

CV Sciences operates two divisions-pharmaceuticals and consumer products. The company’s pharmaceutical line is developing CVSI-007, its initial drug candidate for smokeless tobacco use and addiction, which contains a combination of nicotine and synthetic CBD. The drug candidate was initially developed by CanX Inc., which the company acquired in December 2015. It major focus is on developing synthetically‐formulated cannabidiol‐based medicine that uses cannabidiol as the active pharmaceutical ingredient.

The company develops and markets the PLUSCBD range of hemp-based CBD oils, which is the #1 selling hemp CBD supplement in North America. CV Sciences offers full traceability of the product from Seed to Shelf™, ensuring that the best quality EU certified hempseeds are planted, and the best quality product reaches the store shelves. The company has a state-of-the-art laboratory that adheres to stringent Good Manufacturing Practices (GMP) guidelines, where its full spectrum hemp extracts are processed, produced, and tested during each step of the process to ensure that the CBD meets standards and is free from contamination.

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In addition, the company’s products are also sent to an independent third party lab for testing to ensure that only the best extract, that is free from any pesticides, molds, bacteria, residual solvents, or heavy metals and true to its potency claims, reaches the final customer. It has data from human clinical trials backing the efficacy of its products, besides being the only CBD brand that offers published toxicology work, which support generally recognized as safe (GRAS) independent conclusion.

The company offers a whole range of CBD based products such as CBD Balms, Spray, Drops, Soft Gels and capsules edible gummies and oil roll-ons. Furthermore it also offers CBD oils to wholesalers and retailers for further processing, leveraging its reputation as the leader in manufacturing and distributing agricultural hemp-derived cannabidiol in the natural products industry.

Corbus Pharmaceuticals Holdings, (NASDAQ: CRBP)

Market Cap: $369.80M; Current Share Price: 5.72 USD Chart
Data by YCharts

Corbus is engaged in creating innovative therapies for the treatment of Inflammatory and Fibrotic diseases by harnessing the potential of the endocannabinoid system. This clinical stage company is developing Lenabasum as its lead candidate for the treatment of Systemic Lupus Erythematosus, which is currently undergoing Phase III trials.

Lenabasum is a synthetic small molecule selective cannabinoid receptor type 2 (CB2) agonist that targets chronic inflammation and fibrotic processes. It has shown to promote the production of Specialized Pro-resolving lipid Mediators (“SPMs”) that activate the endogenous pathways which help treat inflammation and achieve bacterial clearance without the need for immunosuppression. It can also limit fibrogenic growth factors that can prevent tissue fibrosis (scarring). The candidate has completed subject enrolment in RESOLVE-1 Phase 3 study for the treatment for systemic sclerosis and expects to report topline results in 2020.

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Its pipeline consists of Lenabasum which is being developed for the treatment of Systemic Sclerosis, Dermatomyositis, and Systemic Fibrosis. In addition, it is studying the efficacy of CBR-4001, a second-generation, peripherally restricted, CB1 inverse agonist for the treatment of organ specific fibrosis including liver, kidney, heart and lung. This candidate will enter phase I trials in 2019 with NIH committing to fund its Phase II studies. It has built a preclinical library of an impressive 600 compounds, which it intends to translate into at least 2 phase I programs each year

Its proprietary technology is safe guarded by a robust Intellectual Property Rights (IPR) portfolio including 4 U.S patents covering composition of matter and broad use in inflammatory and fibrotic diseases that offer it protection through 2034.

In September 2018, the company entered into a licensing agreement with Jenrin Discovery, LLC for gaining the exclusive worldwide rights to more than 600 novel compounds targeting the endocannabinoid system. It has also entered into collaboration with Kaken Pharmaceutical Co. (TYO: 4521) for the development and commercialization of Lenabasum in the Japanese market, in consideration for a $27 million upfront payment and over $173 million in milestone payments and double-digit royalties.

Cannabics Pharmaceuticals, (OTCQB: CNBX)

Market Cap: $36.21M; Current Share Price: 0.2693 USDChart
Data by YCharts

The company uses a proprietary High Content Screening (HCS) platform that offers a combination of innovative screening tools and artificial intelligence, to develop personalized precision cancer medicine, which harnesses the power of naturally occurring cannabinoids to treat cancer. Cannabics HCS platform allows for the screening of numerous compounds derived from cannabis extracts and natural and synthetic cannabinoids, all stored in an extensive library, which also includes a cannabinoid matrix that can assess the effect of combining various compounds.

Cannabics is collaborating with SIMFO, a Germany based CTC lab, for carrying out in-vitro drug sensitivity tests on liquid biopsies using a cannabinoid sensitivity tests. CTC or circulating tumor cells act as valuable sources of tumor information as each cell contains a full cancer genome and transcriptome. They are very useful tools that can be used as predictive markers and used to analyze treatment outcomes. The company also undertakes the genetic profiling of individual patients in order to optimize the treatment plan and outcomes. The use of machine learning algorithms and deep learning models helps take into consideration an individual’s unique environmental and lifestyle data, which will help create customized and effective treatment plans.

In addition, the company has also developed a proprietary capsule, which eliminates the need for vaping or smoking cannabis to derive benefit from the cannabis plant. The capsule has demonstrated long-lasting effects of near 10-12 hours and offers an oral, standardized, reliable and clinically tested route of administration.

The company has successfully completed two clinical trials for Cannabics SR 5mg for Cancer Anorexia Cachexia Syndrome (CACS) and for the Screening of Potential Anticancer Cannabinoid Compounds.

Flavocure Biotech
Flavocure Biotech is developing path-breaking cures for ailments such as Acute Myeloid Leukemia, Pancreatic cancer and Glioblastoma, using cannabis derived molecules, which have demonstrated activity against kinase mutation targets. The company has received an Orphan Drug Designation from the FDA for Creserol™, its very first drug candidate indicated for the treatment of Acute Myeloid Leukemia.

It is focusing on non-cannabinoid small molecules derived from Cannabis plant, for creating therapeutics in areas with large unmet needs in Oncology, Hematological, Soft tissue and Solid tumors, by targeting Kinases and Epigenetics.

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The company’s pipeline consists of candidates for treatment of AML, pancreatic cancers and Glioblastoma, which are undergoing pre-clinical trials to establish proof of concept. Creserol, its lead candidate for the treatment of AML, has been developed in collaboration with research teams at University of Maryland Medical School. FBL-03G, its candidate for pancreatic cancer is being developed in collaboration with Harvard Medical School. FBL-03G is a flavonoid pharmaceutical composition found in a cannabis plant and is primarily derived from cannfavlin B, a part of the cannabis sativa plant.

The company has a very strong intellectual property rights portfolio with over 12 issued patents in the U.S. In May 2019, the company was granted a patent by the U.S PTO for a “therapeutic agent containing cannabis flavonoid derivatives for ocular disorders”.

Axim Biotechnologies, (OTCQB: AXIM)

Market Cap: $40.066M; Current Share Price: 0.6407USDChart
Data by YCharts

 The company is a pioneer in cannabinoid-based pharmaceutical and nutraceutical products that includes a robust clinical pipeline, which targets indications such nausea, pain, restless leg syndrome, spasticity. The company has a worldwide patent on cannabinoid-based chewing gum delivery system, a novel transmucosal, controlled release delivery system for cannabinoid molecules. The system offers increased bioavailability of cannabinoid-API’s, ability to bypass liver degradation, lower dosage, less toxicity and reduced side-effects.

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The company’s lead product candidate is MedChew, a dronabinol-based chewing gum delivery system, indicated for treatment of nausea and pain in patients undergoing chemotherapy and those suffering from AIDS. In addition, MedChew RL is meant for the treatment of restless leg syndrome, while MedChew RX, is targeted towards treatment of pain and spasticity in patients with multiple sclerosis.

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Its nutraceutical line includes its flagship product CanChew Plus™, a CBD-based controlled release chewing gum that consists of hemp oil. It is a first-in-class industrial Hemp derived CBD-rich chewing gum that is approved for sale in all 50 states of U.S

AXIM has 5 issued patents and 12 patents pending in its intellectual property rights portfolio, along with 28 trademarks. The patents include suppository delivery system, combination opioid antagonist and cannabinoid products along with extraction and purification of Delta-9-THC for use in MedChew clinical development program.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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