Bioasis and Bioagilytix 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.
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“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 knowledge, 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.