Defence Therapeutics Receives No Objection from Health Canada for Melanoma Trial

Defence Therapeutics Inc. announced it has received a No Objection Letter from Health Canada. This approval allows Defence to proceed with the Phase I trial of its anti-cancer molecule ACCUM-002 (AccuTOX). The study will focus on patients with unresectable Stage IIIB and IV melanoma.

This trial's primary objectives are to determine the safety and tolerability of intratumoral administration of AccuTOX, both as a monotherapy and in combination with the checkpoint inhibitor Opdualag. Secondary goals include assessing preliminary efficacy, determining the Maximum Tolerated Dose, and establishing the Recommended Phase 2 Dose.

According to Vision Research Reports, the global cancer immunotherapy market is projected to grow from USD 125.73 billion in 2023 to USD 280.11 billion by 2033, reflecting a CAGR of 8.34%. Defence is preparing to conduct this Phase I trial in hospitals in Quebec and Ontario.

CEO Sebastien Plouffe expressed enthusiasm for the commencement of the trial, highlighting AccuTOX as Defence's flagship asset in anti-cancer therapeutics. The company aims to showcase AccuTOX’s safety and effectiveness in addressing unmet clinical needs.