Think back for a moment a few years ago when biotech was just about as popular as you could get. Many stocks ended up topping out in 2015 and early 2016, as growing competition, expiring patents, and potential government efforts to rein in drug prices battered many of these biotechs back to earth.
The iShares Nasdaq Biotechnology ETF (IBB) dropped during mid 2016 and even after seeing immense volatile leaps and falls, the group still remains more than 10% below its all-time high…and this could be signaling new opportunity.
Savvy investors could have serious advantages right now as small biotech companies have already begun surging. For example, look at the performance of the market-cap-weighted iShares Nasdaq Biotechnology ETF, which gained 30% over the past 12 months, and the equal-weighted SPDR S&P Biotech ETF, which climbed 54% during the same period.
Investors are favoring smaller biotechs right now and for our members, we could have an even stronger hand at work right now. The reason? Cannabis biotech trends are beginning to work their way into the mainstream and a previous 346% winner is back in the spotlight after several key announcements have recently been made.
That is why we feel there couldn’t be a better time to re-introduce our readers to Vitality Biopharma (VBIO). This emerging cannabis biotech company is rapidly gaining investor interest while focusing on the treatment of inflammatory bowel disease, narcotic bowel syndrome, and multiple sclerosis.
Furthermore, the Company’s proprietary glycosylation technology for producing cannabinoid prodrugs could, in fact, revolutionize the entire cannabis biotech industry and change how CBD treatments are administered to patients. Steering the ship at the forefront of this technology are two biotech experts who already built two highly successful NASDAQ biotech companies.
But before we get into VBIO’s veteran management team, let’s take a look at a type of technology that could mold the future of cannabis biotech.
Potential Game-Changing Technology
Vitality Biopharma has developed a new class of cannabinoid prodrugs, known as cannabosides. If you’re unfamiliar, “prodrugs” are often designed to improve bioavailability when a drug itself is poorly absorbed from the gastrointestinal tract, or to overcome other issues like harsh side effects. An example of a classic prodrug you’ve probably used before is Aspirin, acetylsalicylic acid, which was first made by Felix Hoffmann at Bayer in 1897 and is a synthetic prodrug of salicylic acid.
Early independent trial results show that VBIO’s technology could change how current CBD treatments are administered.
VBIO’s cannabosides are more stable and soluble than regular cannabinoids, meaning there is less risk of non-psychotropic cannabidiol (CBD) being converted to psychotropic THC or otherwise being degraded or diluted in the acidic stomach environment. Upon ingestion, these cannabosides can enable the selective delivery of THC and CBD to the gastrointestinal tract.
Site-specific delivery could enable oral drug formulations of cannabinoids to provide therapeutic benefits without having THC enter the bloodstream. For example, a prodrug could target a specific tissue or organ, such as the brain or gut, giving the patient better results with far less side effects.
In addition to providing targeted delivery, cannabosides could enable a better tasting formulation for improved patient compliance, better oral bioavailability that provides safer and more reliable dosing, and a delayed release mechanism that enables patients using these medications to have long-lasting, overnight relief.
As of 2015, there were approximately 15 prodrugs classified as blockbusters, meaning they had annual sales exceeding $1billion.
Vitality Bio creates the cannaboside prodrugs through enzymatic glycosylation, a process perfected in 2015. Management believes that glycosylation of cannabinoids can improve product bioavailability, eliminate unwanted side effects, and be useful in any medical treatment where oral CBD is administered at a high dose.
Independent studies have already demonstrated reliable and improved targeting to specific tissue/organs upon oral delivery of GBD glycoside prodrugs vs. active CBD.
The Company’s goal is to ultimately provide a compelling oral cannabinoid pharmaceutical that physicians will be eager to prescribe and patients will prefer.
VBIO Compared to the Competition
– GW Pharma (GWPH)
Many synthetic cannabinoids on the market today are poorly soluble. GW Pharma’s (GWPH) two leading products, Epidiolex® and Sativex® are solutions. Sativex is a mixture of CBD/THC solubilized with 50% v/v alcohol (ethanol) into an oral spray. Although the alcohol volume is small, it can still cause problems for alcoholics, pregnant women, and young children.
Oral lesions may also form in users of alcohol-based cannabis sprays, coupled with reported stinging, bad taste, and dry mouth. Sativex also contains propylene glycol, which may cause further irritation and dry mouth. The product must be stored in the refrigerator and has a shelf life of only 42 days. An oral capsule cannaboside prodrug developed by VBIO may alleviate many of these problems.
– Zynerba Pharma (ZYNE)
Other companies, such as Zynerba Pharmaceuticals (ZYNE), are developing cannabinoid transdermal patches. Transdermal delivery routes can in some cases lead to hives/skin irritation, and typically deliver relatively small drug dosages. Oral cannaboside capsules avoid this problem and could enable far more convenient delivery of cannabinoids in a form that is fast-acting and that works at a high dose for maximal effect.
– Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
Arena Pharma is also in the process of developing synthetic CB2 cannabinoid receptor agonists referred to as APD371. Similar to the solution versus Zynerba’s therapy,VBIO’s option could be far better received, more highly bioavailable, and become a more effective means of pain therapy in the long run.
We’ve said it before and we stand by this now: We believe prodrug development like VBIO’s cannabosides is the future of the medical cannabis industry.
Let’s make one thing clear: We are not saying that GW Pharma, Arena, or Zynerba have poor drug treatments. What we are saying is that we believe VBIO’s technology could make them far better.
Creating prodrugs is already a commercially validated strategy used by big pharma companies to improve drug efficacy and reduce side effects in non-cannabis related drugs. And because the reference drug or original drug already has independent verification and/or approval of its safety and efficacy, the prodrug can be approved much quicker by simply demonstrating similar safety and efficacy as the original.
At the same time, a prodrug can be far more marketable due to its ability to eliminate unwanted side effects or undesirable commercial aspects. A classic prodrug example is Aspirin (acetylsalicylic acid), a synthetic prodrug of salicylic acid.
It comes down to this…
Cannabis biotech is still a very young industry, infant you could even say. And just like how the pharmaceutical industry matured and advanced using prodrug formulations of existing drugs to achieve higher efficacy and less side effects, the cannabis biotech industry will follow the same path.
Drugs like GWPH’s Sativex and Epidiolex may be some of the first drugs to hit the market but that doesn’t mean they are the best, or even the best version of themselves. It is often times the prodrug variation of an approved drug that surpasses the $1billion annual sales mark; like we saw with Aspirin, the prodrug of salicylic acid.
VBIO Drug Pipeline
Through its glycosylation technology, Vitality Bio has produced more than 25 novel cannabosides and has patent applications pending that include composition of matter claims for prodrugs of cannabinoids that have been studied extensively in clinical trials worldwide, including THC, CBD, and cannabidivarin (CBDV).
VBIO’s IP portfolio includes 79 patent claims and almost 200 individual compounds,
…including novel glycoside prodrugs of the most abundant phytocannabinoids, THC and CBD, as well as a variety of other phytocannabinoids and endocannabinoids.
The company aims to develop and receive approval for these proprietary molecules as pharmaceuticals by taking advantage of the more efficient FDA review and approval process that is available for prodrugs. This greatly reduces the need for large and expensive clinical trials.
Because clinical studies have already been performed or are currently still in process for many large commercial indications such as epilepsy, neuropathic pain, multiple sclerosis, inflammatory bowel disease, schizophrenia, and Huntington’s disease, management aims to create improved prodrug formulations of these cannabinoids that ultimately deliver a superior product.
Vitality Biopharma’s two main drugs are moving towards Preclinical and Phase 1a/1b trials:
- VB100 – Inflammatory Bowel Disease, Narcotic Bowel Syndrome
- VB210 – Neuropathic Pain, Irritable Bowel Syndrome, Opiate-induced Bowel
With the current state of the biotech and cannabis markets, we feel it is important for investors to familiarize themselves with VBIO right now. The value and growth opportunities with biotech investments are before they start announcing potentially positive data from Phase I/Phase II/Phase III clinical trials.
That is because positive study data and trial results tend to significantly increase optimism in biotech companies & in turn this has generally reflected favorably to stock prices. In fact we saw this first hand when we initially debuted VBIO when we watched as key developments and market momentum helped to propel this emerging canna-biotech to highs of $4.24 and a near 350% breakout move.
Right now VBIO is focusing initial clinical development efforts on VITA-100, a proprietary THC cannabinoid drug formulation, and plans to complete a first-in-man clinical study in the first half of 2018. The treatment indications the Company plans to evaluate in Phase 2 trials include inflammatory bowel disease (IBD), irritable bowel syndrome, and narcotic bowel syndrome, a severe form of opiate-induced abdominal pain.
The crazy part is, the FDA is already approving medicines derived from THC, which could be a major precursor for the potential for VBIO. Marinol, Syndros, and Cesamet are three cannabinoid-based medicines derived from isolated synthetics. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC). Cesamet includes the active ingredient nabilone, which is synthetically derived and has a chemical structure similar to THC.
For VBIO, their cannabosides could allow for oral delivery of large concentrations of cannabinoids to provide therapeutic benefits. Keep in mind that while this is the case, due to the nature of their therapy, it also reduces or even eliminates psychoactivity by limiting entry of THC into the bloodstream or brain.
To this end, VBIO has just recently submitted an orphan drug designation request for VITA-100 to the U.S. FDA!
“Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries.” – Robert Brooke, VBIO CEO & Co-Founder.
This could pave the way for huge potential for this company in 2018. The reason:
Upon approval, VITA-100 would be designated as an orphan drug for the treatment of pediatric ulcerative colitis, a form of pediatric inflammatory bowel disease.
Strong Management from Successful NASDAQ Biotech Companies
CEO – Robert Brooke
Mr. Brooke is a biomedical engineer and experienced biotech entrepreneur. He was the founder of a drug development company that became Lion Biotechnologies (NASDAQ: LBIO) in 2013. He also co-founded Intervene Immune. Mr. Brooke also had a successful hedge fund stint as an analyst for Bristol Capital, responsible for more than 50 direct healthcare investments.
Chairman & Co-Founder – Avtar Dhillon, MD
Mr. Dhillon has extensive biotech experience. He is currently Chairman of three biotech companies: Inovio Pharmaceuticals (NASDAQ: INO), Oncosec Medical (NASDAQ: ONCS) and Arch Therapeutics (ARTH). He has also raised over $200 million in public markets to ensure that his companies have sufficient research funding that is critical to a biotech company’s success. Mr. Dhillon is also a former venture capitalist and family physician for more than 10 years.
Director of Research and Development, Scientific Co-Founder – Brandon Zipp, PhD
Dr. Zipp is a scientist with over 10 years of research experience with glucosyltransferase enzymes – the enzymes used in VBIO’s proprietary development process. He has a Ph.D Biochemistry and Molecular Biology from the University of California, Davis.
We always say you invest in management. No matter how great a company’s product or technology is, you need a capable management team to properly bring it to market. A cure for cancer in a lab does a company and its shareholders no good if the management team cannot commercialize the drug and bring it to market.
Companies can encounter financial hurdles and operational speed bumps along the way but a good management team can overcome these obstacles while staying focused on their goal. By progressing through their business plan, it allows the company to build shareholder value and this is why it is important to invest in companies with proven and successful management teams.
The medical marijuana and cannabis industry is booming. And the biotech industry is poised for a massive bull run especially considering the Nasdaq Biotech Index (IBB) Is up nearly 30% over the last 12 months! Right now could be the perfect time to add cannabis biotech to your portfolio.
What was hype and speculation back in late 2013 and into 2014 is now an investable market with tremendous upside. At the center of the industry are things like biopharma research and development being pioneered by companies with proprietary technology and the intellectual property leading to exciting medical breakthroughs.
Just as prodrug development advanced the non-cannabis pharmaceutical market with things like aspirin (which is now widely available), we expect similar technology to help mature an infant biotech cannabis industry.
VBIO’s most advanced candidate is VB100, a cannaboside prodrug under development for the acute management of inflammatory bowel disease and an orphan drug designation request has recently been submitted. A second candidate, VB210, is under development for chronic conditions that affect both the GI and CNS.
With a strong IP portfolio of 79 patent claims on over 200 compounds and a proven, successful management team, VBIO could be set up to benefit from an overall cannabis biotech rally and members have already seen what real potential is like especially from VBIO. As the markets begin to ramp up during the 1st quarter, will another VBIO rally trigger new highs for this budding canna-biotech?
Pursuant to an agreement between MAPH and a non affiliate third party, we were hired for a period of 30 days to publicly disseminate information about (VBIO) including on the Website and other media including Facebook and Twitter. We are being paid $100,000 (CASH) for or were paid “ZERO” shares of unrestricted or restricted common shares. We own zero shares of (VBIO), which we purchased in the open market. We plan to sell the “ZERO” shares of (VBIO) that we hold during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of (VBIO) in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.