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Message: Bioasis Announces FDA Response to Pre-IND Submission
Bioasis Announces FDA Response to Pre-IND Submission
Jun. 25, 2019, GUILFORD, Conn.
GUILFORD, Conn.–(Business Wire)– Bioasis Technologies Inc. (TSX.V:BTI; OTCQB:BIOAF) (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 ™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announced it had received feedback to its pre-Investigational New Drug (”IND”) submission to the U.S. Food and Drug Administration (“FDA”) regarding the planned development of xB3-001, the Company’s lead investigational candidate to treat brain cancer.
In May 2019, Bioasis submitted to the FDA its pre-IND briefing document in support of the xB3-001 program for the treatment of patients with confirmed human epidermal growth factor receptor 2 (“HER2”)-positive (“HER2+”) breast cancer and brain metastases.
“We are pleased to have completed the pre-IND process, with the FDA providing helpful guidance for the continued advancement of xB3-001 for the treatment of HER2+ human brain metastases, an indication with an urgent and significant unmet medical need,” said Deborah Rathjen, Ph.D., Company Chair and Chief Executive Officer. “We appreciate the FDA’s feedback as we endeavor to treat HER2+ brain metastases utilizing our innovative and robust blood-brain-barrier technology.”
The Company’s lead program, xB3-001, an xB3 peptide vector trastuzumab fusion, is being readied for clinical testing for the treatment of HER2+ breast cancer brain metastases. Preclinical studies have demonstrated that xB3-001 can deliver an efficacious level of trastuzumab to established HER2+ human breast cancer brain metastases in a non-invasive manner, while trastuzumab alone had minimal brain uptake and no impact on both the size and number of brain tumors.
Bioasis Technologies Inc. is a biopharmaceutical company developing the xB3 ™ platform, a proprietary technology for the delivery of therapeutics across the blood brain barrier 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 blood brain barrier 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 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.us.
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, along with other 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.
Deborah Rathjen, Ph.D.
+1 203 533 7082
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