Bioasis Announces FDA Response to Pre-IND Submission

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.

ABOUT Bioasis
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

Forward Looking Statements
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Deborah Rathjen, Ph.D.
[email protected]
+1 203 533 7082