On February 16, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various products for the immuneoncology space, is pleased to reported the establishment of an agreement with Cato SMS, to advise on the submission of its clinical application to Health Canada in order to initiate a Phase I trial using AccuTOXTM against breast cancer (Press release, Defence Therapeutics, FEB 16, 2022, View Source [SID1234626247]).
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CATO SMS is a consulting firm with more than 30 years of global experience to guide clinical development of biopharma pipelines. With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trial designs in more than 25 countries. Their specialists deliver innovative regulatory consulting solutions to guide complex challenges with a proven center of excellence in oncology.
"We are very pleased to work with Cato SMS on our AccuTOXTM program. This step is central to Defence as it ensures the achievement of important milestones for our clinical program. Cato SMS will be designing the clinical protocol, pre-CTA meeting package, CTA Compilation and Submission as well as regulatory affairs for our AccuTOXTM Phase I trial" says Mr. Plouffe, the CEO of Defence.
The AccuTOXTM program consists of using a lead variant of the AccumTM molecule to trigger cell death in cancer cells. When combined with the immune-checkpoint inhibitor CTLA-4, this lead AccumTM triggered potent anti-tumoral response in several cancer models including, T-cell lymphoma, melanoma, colon and breast cancer. As such, Defence plans to use AccuTOXTM in its Phase I to treat breast cancer patients in Q4 of 2022.
According to Fortune Business InsightsTM, the Global Breast Cancer Therapeutics Market to exhibit 13.1% CAGR and hit USD 55.27 Billion till 2027.