Tailwinds’ Take: this long awaited update from the new CEO shows that he’s a thoughtful, reasoned leader who understands the technology and its place in the medical field. Going forward, biOasis will have a disciplined logical approach to studies that will (if successful) drive demonstrable value for shareholders with each study. Rob found himself a great partner in Mark Day.
VANCOUVER, BC–(Marketwired – June 13, 2017) – BIOASIS TECHNOLOGIES INC. (BIOAF) (TSX VENTURE: BTI) Dr. Mark Day, chief executive officer, has issued a message to shareholders detailing plans for the advancement of the Transcend Platform and the company’s in-house programs.
To the Shareholders of biOasis Technologies Inc.:
As the new CEO of biOasis, I am delighted to send my first message to shareholders, especially at a time when there is such excitement in the neurosciences. Scientists are beginning to understand the surreal complexity of the central nervous system (CNS), how to explore further into its mysteries, to understand its workings, diagnose its diseases, and how to accurately monitor the progress of CNS diseases and the efficacy of the drugs that treat them.
I and my many friends and colleagues in the industry are moving ahead on many fronts. Celgene and Vertex have recently moved into the CNS arena under the guidance of two exceptional R&D leaders. In 2014 the Nobel Prize in Physiology or Medicine was awarded to a team that made breakthrough discoveries on spatial memory, discoveries that have informed my own work.
Several significant breakthroughs were made in the last year. The most exciting for me was with Alzheimer’s disease. Biogen demonstrated their aducanumab could slow the progression of Alzheimer’s disease in mild-to-moderate patients. This truly was a first and shows that when you prioritize science, you can yield truly astounding results.
And now, as CEO of biOasis, I find myself right in the middle of this new era in neuroscience with what I have previously called, “one of the most unique and promising blood-brain barrier technologies of our time.” Despite all the advances in neuroscience, the ability to transport drugs across the blood-brain barrier has remained elusive, something I believe biOasis and our Transcend Platform can address.
During the past few weeks, I have completed assessments of the Transcend Platform, the studies and data relating to the platform, the company’s Transcend patent portfolio and the two business models developed by the company. I have come away from this process more excited than ever. I believe the Transcend Platform, with its unique abilities, simplicity and comprehensive intellectual property (IP) protection, enables the two business models, and that the company should immediately move forward with them.
In the remainder of this first letter to shareholders, I will discuss the company’s internal clinical programs. In a future message, I will similarly discuss the company’s licensing model. I believe it is important for the pharmaceutical industry to keep pace with biOasis with respect to the delivery of drug candidates across the BBB and into the CNS. The Transcend licensing model will allow our future licensees to do that.
We Are a Science-Focused and Science-Driven Company.
Our focus is to do the right studies, at the right time, for the right reasons, a focus designed to bring success. We must avoid the mistake of rushing into clinical studies until we are certain we have the right endpoints. Otherwise we will succumb to the same issues that have led to the collapse of many biotech companies before us. Our studies and trials must have the right “go” or “no-go” endpoints.
The value in Transcend is the potential to turn non-brain-penetrant drugs into novel medical entities, to deliver them to the brain and to treat a range of disorders across oncology, lysosomal disorders and neurodegenerative diseases. A drug that did not treat the neurological aspects of a disease but can now be non-invasively delivered to the brain is not just a “bio-better,” it is a differentiated product.
In the immediate near term, our aim is to select, in a disciplined manner, the best assets to take into patients. This is not something to be undertaken without due consideration. We need to ensure the drugs have the following characteristics:
- Target Engagement: The drug must reach its target in the brain (e.g., brain metastasis/glioblastoma) in sufficient quantities to be able to test the hypothesis in the clinic. Most drugs fail because they fail to get enough of the drug to the target.
- Pharmacodynamic Activity: Once at its destination in the brain, the drug/target interaction should drive a biological consequence (e.g., in schizophrenia this could be the reduction of dopamine, a brain chemical that is excessive in the disease).
- Patient Selection: We must ensure we have the right patient population to test.
Our plan is to utilize non-invasive, non-human primate (NHP) brain imaging to assess eight targets (across oncology, rare diseases and neurological indications) for their ability to get to the needed site of action in the brain. Only those targets showing actual target engagement will advance into phase 0 microdosing studies. This means we advance only those drugs where we see significant uptake in NHP imaging. The drugs with the best brain uptake will be prioritized for their use in human phase 0 studies.
Details of these studies will be released when our plans are completed. The NHP studies will not directly impact the previously discussed phase 0 clinical trial in oncology. We have already selected a manufacturer to produce the clinical-grade fusion proteins required for the study. The development of the cell line to produce the fusion protein and the manufacturing of the required quantity of the drug will take up to a year to complete.
It’s also essential to recognize one of the main receptors Transcend utilizes to trick the brain into opening the BBB is expressed in important regions of the brain, including areas critical to learning, memory, mood and impulsivity. This receptor is significantly expressed in glioblastomas and in key areas of the brain involved in a plethora of psychiatric and neurological diseases. I think these represent very intriguing targets for biOasis.
With respect to our in-house programs, it is essential for biOasis to have access to the best scientific advice available. To that end, we are currently creating a Scientific Advisory Committee with its members to be chosen from among the world’s top scientists. We are also assessing our internal expertise and management requirements. In the very near future, I expect to be making announcements about strategic appointments to address those requirements.
The biOasis in-house programs are a major undertaking. They are being developed in a robust scientific manner, with meaningful targets chosen to help ensure success. That success could produce ground-breaking results and could herald a broadly-recognized new era in neuroscience. I believe it’s possible, and that’s why I want to be right here at biOasis, and nowhere else.
In my previous roles in pharma, I have passionately driven research and development (R&D) and business development (BD) programs and I have succeeded in delivering new innovations to the R&D and BD processes. As CEO, I intend to bring the same dedication and vision to biOasis.
I want to thank the Executive Chairman, the Board of Directors and all our shareholders for this opportunity. Together we will accomplish great things and I look forward to working with you.
Mark Day, Ph.D.
Chief Executive Officer
biOasis Technologies Inc.
Transcend is biOasis’ proprietary platform for the delivery of therapeutics across the blood-brain barrier to address unmet medical needs in the treatment of metastatic brain cancers as well as neurodegenerative and metabolic diseases. The delivery of therapeutics across the blood-brain barrier represents the single greatest challenge in treating neurological disorders. The ability to effectively and safely transverse the blood-brain barrier with the Transcend peptide carrier, MTfp, offers the opportunity for biOasis to deliver therapeutics into the brain at doses sufficient to have a therapeutic effect.
biOasis Technologies Inc. is a biopharmaceutical company headquartered in the Vancouver, Canada area, focused on overcoming the limitations of therapeutic drug delivery across the blood-brain barrier (BBB). The company is developing and commercializing a proprietary brain delivery technology to address unmet medical needs in the treatment of central nervous system disorders. biOasis trades on the OTCQB under the symbol “BIOAF” and on the TSX Venture Exchange under the symbol “BTI.” For more information about the company please visit www.bioasis.ca.
Forward Looking Statements
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments express or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: products that we develop may not succeed in preclinical or clinical trials, or future products in our targeted corporate objectives; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and the costs of launching our products may be greater than anticipated; we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward- looking statements and information to reflect subsequent events or circumstances, except as required by law.
On Behalf of the Board of Directors
Rob Hutchison, Chairman of The Board of Directors
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