Health Canada Approves Phase I Trial of ACCUM-002 (AccuTOX) for Melanoma

Defence Therapeutics Inc., a biopharmaceutical company based in Vancouver, British Columbia, has announced a significant development in its ongoing research and development efforts. The company has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Study ACCUM-002-01, titled "A Phase I trial of Intratumoral Administration of ACCUM-002TM as a Monotherapy and in Combination with Opdualag in Patients with Unresectable Stage IIIB and IV Melanoma."

This study aims to evaluate the safety and tolerability of the intratumoral administration of AccuTOX®, both as a standalone treatment and in combination with Opdualag, a drug that combines the LAG-3 checkpoint inhibitor relatlimab and the PD-1 inhibitor nivolumab. Secondary goals include gathering preliminary efficacy data and determining the Maximum Tolerated Dose (MTD) and the recommended Phase 2 Dose (RP2D) of AccuTOX®.

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Defence Therapeutics is gearing up for this Phase I clinical trial in Canada, with the potential trial sites likely to be located in Quebec and Ontario. The specific hospitals involved will be confirmed once agreements are finalized.

"AccuTOX® is Defence's flagship asset in the anti-cancer therapeutics field. This Phase I clinical trial will primarily demonstrate its safety and secondly confirm its potency. We are thrilled to be preparing for this trial in Canada," stated Sebastien Plouffe, CEO of Defence Therapeutics. "Defence remains committed to addressing unmet clinical needs and aims to become a global leader in the development of innovative anti-cancer therapies."

Defence Therapeutics is a publicly-traded biotechnology company in its clinical stage, focused on developing next-generation vaccines and Antibody-Drug Conjugates (ADCs) using its proprietary platform. The core of Defence's technology is the ACCUM® platform, which allows for precise delivery of vaccine antigens or ADCs into target cells, enhancing their processing and activity. This leads to increased efficacy and potency in combating severe illnesses such as cancer and infectious diseases.