RICHMOND, British Columbia & GUILFORD, Conn. & DURHAM, N.C.--(BUSINESS WIRE)--BIOASIS TECHNOLOGIES INC. (TSX.V:BTI; OTCQB:BIOAF), a biopharmaceutical company developing its xB3 TM proprietary platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders, and BIOAGILYTIX, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, today announced a strategic collaboration to partner on the development and validation of bioanalytical methods to support and advance the xB3 TM-001 program, Bioasis’ lead candidate to treat HER2+ brain cancer, to investigational new drug (IND) submission and into the clinic. The development and validation of bioanalytical methods are critical to ensuring the highest quality data to support regulatory approval of the IND and clinical pharmacokinetic data that will allow the Company to define the clinical dose for the program to ensure maximum therapeutic benefit for patients in Phase 1 and beyond.
“BioAgilytix is a globally-respected leader in immunoassays, and we are tremendously pleased to be working with them on our bioanalytical method development and validation across a number of parameters to support the IND submission and Phase 1 clinical trial for our lead program in HER2+ brain cancer,” said Mark Day, Ph.D., president and chief executive officer, Bioasis. “BioAgilytix’s expertise and experience in large molecule bioanalysis as well as expertise with trastuzumab analytics will be instrumental to advancing this program.”
“We are excited to be working with Bioasis to advance their lead program in HER2+ brain cancer with the xB3 platform technology. We support Bioasis’ mission to aggressively advance this program to bring innovative treatments to patients with brain cancer,” said Jim Datin, president and chief executive officer, BioAgilytix. “We are committed to applying our superior science and expert capabilities – which cover every phase of development, from discovery to global Phase III trials – to achieve Bioasis’ deliverables and timeline, adhering to high quality standards and working collaboratively together as a strategic partner and problem solver.”
Through this partnership, Bioasis will have access to BioAgilytix’s extensive bioanalytical expertise, particularly in ligand binding assays, anti-drug antibody detection, stability assessments across complex matrices and highest quality GLP validation of complex assays. BioAgilytix will ensure that Bioasis will be able to generate high quality, reproducible data that will help deliver needed medicines for patients suffering from brain cancer.
Bioasis Technologies, Inc. is a biopharmaceutical company developing xB3, a proprietary platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases. The delivery of therapeutics across the BBB represents the final frontier in treating neurological disorders. The in-house development programs at Bioasis are designed to develop symptomatic and disease-modifying treatments for brain-related diseases and disorders. The company maintains headquarters in Richmond, Canada with offices in Guilford, Conn., United States. Bioasis trades on the TSX Venture Exchange under the symbol “BTI” and on the OTCQB under the symbol “BIOAF.” For more information about the company, please visit www.bioasis.ca or www.bioasis.us.
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.).
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
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.
“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.”