BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), a pioneering biopharmaceutical company focused on the delivery of therapeutic drugs across the blood-brain barrier (BBB), has provided a corporate update in advance of its Annual and Special Meeting of Shareholders to be held at 1780 – 400 Burrard Street, Vancouver, BC, on January 23, 2017 at 10:00 AM, PST.
2016 was a pivotal year for biOasis. Several initiatives and events contributed to the accelerated advancement of the commercialization of Transcendpep, the company’s breakthrough peptide-based platform technology for the transport of therapeutic drugs across the BBB.
Licensing Agreements – Expanding the Deal Flow Pipeline
The depth and quality of the biOasis Deal Flow Pipeline has been significantly expanded and now consists of several projects in various stages of action or development. During 2016 the company announced licensing agreements with Astellas Research Institute of America LLC, and with Vaccinex Inc. In addition, three evaluation and validation studies are underway, and another five agreements are under active development. Still other pharmaceutical companies have completed their initial studies with biOasis, leaving them with decisions to be made about whether, when and in what manner they wish to advance their drug candidates through their internal clinical pipelines.
Pharmaceutical Industry – Increased Confidence in biOasis
Several factors have contributed to the pharmaceutical industry’s increased interest and confidence in biOasis and the Transcend Platform. U.S. patent No. 9,364,567, “Fragments of P97 and uses thereof,” was issued to biOasis on June 14, 2016. This and other patents allow biOasis to readily provide the Transcend peptide’s structural sequence of amino acids and diverse linkers to pharmaceutical companies with the confidence that biOasis’s intellectual property will remain fully protected. For the pharmaceutical companies, the peptide and its patents open up markets for Transcendpep-based fusion proteins and small molecule drugs that will also benefit from similarly strong intellectual property protection.
Industry confidence is also benefitting from the exceptional Transcendpep performance data produced in animal studies conducted by biOasis with several highly reputable third parties. These data indicate that the Transcendpep is not only able to transport large quantities of therapeutic drugs across the BBB, but also that the half-life, pharmacokinetics, pharmacodynamics, safety and other attributes of the transported drugs are not materially affected, and in fact many of these attributes are enhanced by their transport across the BBB by the Transcendpep and linkers.
On a practical level, this increased confidence in biOasis and the Transcend Platform has resulted in greater allocations of funding and resources by the pharmaceutical companies for parallel pharmacokinetic and pharmacodynamic studies with disease-state animals. Previously, the pharmas conducted basic pharmacokinetic studies with wild-state animals. The parallel studies allow determination of not only the quantity and location in the brain of a delivered drug, but also its effect on the disease-state animals. The expanded studies are expected to move the licensing processes forward with increasing speed, a benefit to both biOasis and its prospective licensing partners.
Commercialization Strategy – Networking in the Pharmaceutical Industry
biOasis’s continued participation in numerous pharmaceutical industry conferences is also contributing to the expansion of the biOasis Deal Flow Pipeline. During 2016, biOasis attended several events including BIO Europe, BIO International and the 35th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The increased exposure of the company and the Transcend Platform to the pharmaceutical industry at these conferences continues to pay high dividends for biOasis.
The recent J.P. Morgan Healthcare Conference was a very busy time for biOasis with twenty-five meetings over three days. The company met with representatives from some of the world’s largest pharmaceutical companies, as well as representatives from some of the smallest. No matter their size, many of these companies offer some of neuroscience’s most exciting opportunities.
biOasis also met with pre-clinical and clinical Contract Research Organizations that may be able to assist the Company with the advancement of its internal programs through clinical trials. biOasis will require such services for the advancement of its in-house oncology programs. The three days at JPM resulted in the planning of tangible actions on multiple fronts that are expected to commence within the first quarter.
The biOasis Oncology Program – An Important Scientific Paper
biOasis continues to develop its internal business model, the development of plans, specifications and funding for the advancement to human clinical trials of biOasis fusion proteins for the treatment of brain tumors.
On August 29, 2016, biOasis announced the publication of a peer-reviewed scientific paper detailing the results of an in vivo study of the treatment of metastatic HER2-positive breast cancer brain tumors in an animal model using BT2111, biOasis’s Trastuzumab-Melanotransferrin (Transcend) conjugate.
The paper, entitled, “Anti-cancer antibody Trastuzumab-Melanotransferrin conjugate (BT2111) for the treatment of metastatic HER2-positive breast cancer tumors in the brain: an in vivo study,” detailed a study that showed that the biOasis Transcend-Trastuzumab (Herceptin) conjugate, BT2111, reduced the number of metastatic human HER2-positive breast cancer tumors in the brains of test animals by 68 percent compared with control animals. Tumors that remained after treatment were 57 percent to 60 percent smaller than those in the control animals, resulting in an overall reduction of tumor volume of over 85 percent. In contrast, neither the administration of Trastuzumab alone nor MTf (Transcend) alone was accompanied by a reduction in brain tumor number or size.
Commented biOasis CEO, Rob Hutchison, “On a personal note, without question the past two years have been at the same time both challenging and very exciting. 2015 saw us complete the balance of the characterization of the peptide from 2014 along with an understanding of how to best link or combine Transcendpep into a host of therapeutic compounds. “
“2016 brought the start and rapid expansion of the biOasis Deal Flow Pipeline – the signing of two license agreements and now eight evaluation studies either started or are about to commence. I’d personally say that significant milestones were met.”
“On the public side, I fully understand that although we within the Company are busy and excited, that sometimes due to confidentiality issues, the excitement doesn’t make it out beyond the four walls of the Company. The timelines of the pharmas are so variable and they sometimes seem to drag on. This is where I believe an expanding Deal Flow Pipeline becomes important. As time passes, it should enable us to see real progress in multiple areas and to provide more information that will allow our internal excitement to be shared with all of our shareholders.”
“The Annual General Meeting always heralds a new year and the closing of the old. We at biOasis are moving forward with high confidence that our accomplishments in 2016 will help us achieve our hopes and expectations for 2017.”
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, Transcendpep or MTfpep, offers the opportunity for biOasis to deliver therapeutics into the brain at doses we believe, 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 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, Chair & CEO
“Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release”
biOasis Technologies Inc.