Defence Therapeutics receives a no objection letter from Health Canada for a Phase I Trial of ACCUM-002 (AccuTOX) as an anti-cancer molecule in patients with melanoma.
Defence Therapeutics Inc, a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, is pleased to announce that it received a No Objection Letter (“NOL”) from Health Canada for its Clinical Trial Study number ACCUM-002-01 entitled “A Phase I trial of Intratumoral Administration of ACCUM-002TM as a Monotherapy and in Combination with Opdualag in Patients with Unresectables, Stage IIIB and IV, Melanoma”.
The primary objectives of this study are to determine the safety and tolerability of intratumoral administration of AccuTOX®, as a monotherapy and in combination with Opdualag which combines the LAG-3 checkpoint inhibitor relatlimab and PD-1 inhibitor nivolumab. The secondary objectives are to obtain preliminary efficacy data and to determine the Maximum Tolerated Dose (“MTD”) and recommended Phase 2 Dose (“RP2D”) of AccuTOX® exploits as an immune booster and anti-cancer molecule.
The Defence team is already preparing Phase I in Canada, most likely to be conducted in Quebec and Ontario. The hospital’s sites will be confirmed upon agreement finalisation.
“AccuTOX® is Defence’s flagship asset in the anti-cancer therapeutics field and this Phase I clinical trial shall demonstrate and confirm primarily its safety and secondly its potency. We are thrilled to getting ready for this Phase I in Canada. Defence remains committed to its mission of addressing unmet clinical needs and in pursuing its goals to become a global leader in the development of innovative anti-cancer therapies,” said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.
