Defence Therapeutics has announced it is performing a final preclinical study to validate the efficacy of AccuTOXTM combined with immune-checkpoint inhibitors before initiating a Phase I cancer clinical trial.
The AccuTOXTM Phase I cancer clinical trial will involve patients enrolled at the City of Hope National Medical Center and Beckman Research Institute. Defence Therapeutics has completed all required preclinical and GLP studies on AccuTOXTM – the Company’s leading compound.
The injectable treatment for solid tumours has been demonstrated to effectively control tumours following intratumoral administration three times per week in combination with anti-PD-1, anti-CTLA4 or anti-CD47.
What will the Phase I cancer clinical trial involve?
The trial will be conducted by Dr Yan Xing, a leading physician and oncologist with a PhD from the University of Texas, a fellowship in medical oncology from the Houston Methodist Hospital, as well as a fellowship in Phase I clinical trials from the MD Andersen Cancer Center.
Dr Xing aims to enhance cancer treatment and outcomes through rigorous data analyses to determine better which practices work best. Defence will perform a preclinical study in which AccuTOXTM will be administered twice a week over a three-week period under Dr Xing’s recommendations.
This study’s plan would significantly decrease the number of weekly hospital visits for cancer patients. The AccuTOXTM will be delivered as a combination therapy with both anti-PD-1 and anti-LAG3. The latter immune-checkpoint inhibitor combination is similar to the use of Opdualag (a BMS-premixed combination of nivolumab and relatlimab), which is currently being administered to cancer patients at the City of Hope National Medical Center and Beckman Research Institute.
Prior clinical studies have shown that employing Opdualag has doubled the median progression-free survival of patients with advanced melanoma. The AccuTOXTM combination therapy with Opdualag is anticipated to elicit a greater therapeutic impact on cancer patients. The study is expected to be complete by the end of April 2023. Defence plans to finalise its IND filings through the City of Hope National Medical Center and Beckman Research Institute by May 2023.
Sebastien Plouffe, the CEO and president of Defence, concluded: “The ongoing in vivo study will highlight potential potency differences using a different administration regimen, and in addition, it may determine this novel combination that can further enhance the therapeutic potency of AccuTOXTM.”