VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 06/18/13 -- biOasis Technologies Inc., (TSX VENTURE: BTI) an industry-leading provider of technology to potentially deal with the unmet medical need of shuttling therapeutic compounds across the Blood-Brian Barrier, with its Transcend technology, issued the following letter:
Dear fellow biOasis Shareholders:
The past 12 months have been marked by a number of significant accomplishments. I would like to highlight a few of those, review our core Transcend technology, and the opportunities before us.
biOasis is actively engaged in the development of a proprietary vector (Transcend) for the transport of therapeutic agents across the blood brain barrier ("BBB").
The BBB is a very specialized barrier system of endothelial cells that regulates molecules accessing the brain. The BBB provides an insulated environment for stable function of the cells that make up the brain. As such, this barrier prevents approximately 98% of small molecule drugs and almost 100% of larger biologic drugs (antibodies, enzymes, etc.) from entering the brain in levels that would be useful therapeutically. By linking therapeutic agents to Transcend, biOasis is developing new classes of brain penetrating drugs and offering pharmaceutical companies the opportunity to greatly expand the commercial potential of a range of their key therapeutics.
We have been working on the biOasis technology for many years. Dr. Wilf Jefferies and his team of scientists, some of who are now working at biOasis, created what we are now branding as Transcend(sm). The history of how the technology came to exist and how it works is a fascinating story. It is well told in "The Transcend Story" which you can find at http://bioasis.ca/programs.htm
After several years of externally vetting the technology with quality independent third parties, such as: National Research Council of Canada, BC Cancer Research Centre, St. Paul's Hospital iCapture, Fleet Bioprocessing, London, England, Southern Research Institute, BRI Pharmaceuticals, and Texas Technical University Department of Pharmacy, in 2012 we began taking serious steps required to advance our technology towards commercial development.
During this vetting period, we expanded our patent portfolio covering the intellectual property underlying Transcend and continue to actively pursue additional patents for our overall technology. We now have over 30 patents and patent applications.
We entered into four important strategic collaborations with world-leading Pharmaceutical companies that wanted to "get their hands on Transcend" to see if it could be used with their target therapeutic compounds. These are:
1. Shire HGT2. AbbVie3. MedImmune4. UCB Pharmaceuticals
For a company at the stage of biOasis's to engage these world-class companies in such short order was a major milestone.
These events fit perfectly into the overall business strategy for our company, which can be summarized as follows:
-- Obtain independent 3rd party validation of Transcend-- Expand and protect the Intellectual Property portfolio-- Advance the development of a small number of programs internally and for our own account - the ones that are relatively low cost, have the potential to achieve major milestones in the short to mid term and have large market potential-- Collaborate with reputable Pharmaceutical companies that are interested in the potential of Transcend - creating numerous shots on goal - leading us ultimately to commercial transactions with numerous strong partners or licensees.
We cannot expect our technology to work with every potential partner's therapeutic target, so our goal is to bring a number of collaborators to the table. The interest we are getting from within the industry remains very positive.
In dealing with the current collaborations underway, I wish I could share the details; however, we are bound by confidentiality agreements to protect both our collaboration partners and us. To preserve scientific rigor in some cases we are "blinded" to the nature of our partner's therapeutic agent so we will not know the outcome of the project until everything is complete. What I can tell you is that all of our collaborations are progressing and the results we've obtained to date have met our expectations. As well, our science and business teams at biOasis hold regular meetings with collaboration partners to discuss the progress of the research and exchange ideas. Each of our current collaboration partners are large organizations, expending significant capital and internal resources to assess our Technology for their needs. To us this highlights the potential value Transcend may have to these organizations.
As part of our evaluation of the potential of the Transcend technology, we ran an internal selection process to look at existing therapeutic compounds that were known not to cross the blood-brain barrier on their own. If we could demonstrate that our technology could get any one of these candidates across the BBB this would address a very large unmet medical need and therefore potentially be of interest to the owners of those compounds.
Once identified, we prioritized the list based on market size, cost to develop, likelihood of short to mid term milestone achievement and overall risk. This enabled us to target the companies we chose to collaborate with on our Transcend technology and to the collaborations listed above. In addition it allowed us to decide which programs we would advance further internally and for our own account.
The main program we are pursuing internally is called BT2111; where we have linked Transcend with trastuzumab (Herceptin)(i). The results on this program to date have been very encouraging. The current market for Herceptin is greater than 5.9 billion dollars annually.
(i) Herceptin is a registered trademark of Roche/Genentech
Highlights of the BT2111 Studies:
-- The BC Cancer Research Centre showed in a human HER2+ breast carcinoma model, that BT2111 had an increased cancer killing effect over Herceptin on its own. BT2111 under their test, killed more cancer cells outside of the blood-brain barrier than the drug itself. This was a surprising and very positive development.-- Texas Technical University, after a great deal of testing, came out with, in our opinion, a remarkable set of results.
It is worth some background about this study to help put it in context;
-- There were three groups of subject animals used; a control group that received normal saline, a group that was dosed with Herceptin alone, and a group that received BT2111 - all dosed intravenously.-- After a lot of prep work, all the animals were injected into the left ventricle of their heart with a "human" HER2+ cancer cell line. Twenty- one days later all the animals had on average approximated 90 brain tumors, and the therapeutic injections began.-- Each animal received two injections per week between day 21 thru day 35, meaning they received only 4 injections each. At day 35 all the animals where euthanized and the brains where then sectioned and sliced. The slices where then prepared and analyzed under a microscope.-- In a matter of two weeks with 4 injections, they found that the BT2111 group had 68% fewer tumors than both the two other groups.-- In addition, the tumors that remained were 58% smaller in size versus the other two groups.
The work on BT2111 at Texas Tech continues with a number of further tests required to complete our pre-clinical testing of BT2111.
This program has identified two benefits for biOasis;
1. It is a program that biOasis itself could advance further on its own and without a partner (as the costs of doing so are manageable) or license it off to a partner potentially as soon as the next set of tests are completed, and2. Therapeutic antibodies are the number one drug targets for many Pharmaceutical companies. Due to the large size of these compounds delivery throughout the body becomes a major issue and in the brain it is the major issue. Our work on BT2111 showed the industry that Transcend was not only able to deliver a therapeutic antibody, but do so in sufficient quantity to have a therapeutic effect.
Many of you have asked me about our Cognitest program - our test to measure elevated levels of p97 in blood as a potential diagnostic utility for Alzheimer's. For now we've put it on the shelf and stopped expending corporate resources on it. We are focusing on Transcend where we see the best opportunity to create value for our shareholders. However, work continues at UBC where fresh human samples are being analyzed. This work is likely to continue for several months to come. The exact time frame for these results is tough to determine, but as soon as we have a statistically significant number of samples we will re-assess the commercial viability of this program.
Notwithstanding all of this activity and progress, we are spending only approximately $165,000 per month, a remarkably low burn for such technical advancement and our current cash position is approximately $3M.
Over the next year we will focus on a number of exciting activities, including near term objectives; the completion of the current collaborations and to complete certain BT2111 studies underway, and mid to longer term objectives to continue to seek and bring on new collaboration opportunities, advance our BT2111 program as rapidly as our resources allow and bring new internal programs that we've been working on to the forefront.
We feel biOasis is well positioned to move forward. We believe we have strong intellectual property underpinning Transcend, excellent strategic collaborators focused on large market opportunities, an exciting internal pre-clinical development program and a strong team of scientists and managers at biOasis.
We have an exciting year ahead and we look forward to sharing it with you.
Rob Hutchison, Founder and CEO
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: we may not be able to successfully develop and obtain regulatory approval for p97 as a Physician's Aid to Diagnose Alzheimer's, 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.
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biOasis Technologies Inc.
Founder and CEO