Defence Therapeutics Inc. announced that it is currently conducting a final pre-clinical study aimed at validating the efficacy of AccuTOXTM combined to immune-checkpoint inhibitors akin to the clinical design to be used on patients to be enrolled in the Phase I cancer clinical trial planned at the City of Hope National Medical Center and Beckman Research Institute. Defence has completed all required pre-clinical and GLP studies on its lead compound AccuTOXTM as an injectable for solid tumors. The Defence team has shown that tumors are effectively controlled following intratumoral administration of AccuTOXTM three times per week in combination with anti-PD-1, anti-CTLA4 or anti-CD47. Dr. Yan Xing, who will conduct Defence's Phase I cancer clinical trial at City of Hope National Medical Center and Beckman Research Institute, is a physician, oncologist that has a
Ph.D. in biostatistics 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. Yan Xing strives to improve cancer treatment and outcomes through rigorous data analyses to better determine which practices work best. Under Dr. Xing recommendations, Defence will perform a preclinical study whereas the treatment will be twice a week over a three-week period. Defence's AccuTOXTM ongoing pre-clinical study has implemented a plan to be closely matched as the Phase I cancer clinical trial. AccuTOXTM will be delivered twice a week over a total period of three weeks. This study plan would significantly decrease the number of hospital visits per week for cancer patients. The AccuTOXTM will be delivered as 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. Clinical studies have shown that the use of Opdualag has doubled the median progression-free survival of patients with advanced melanoma. The AccuTOXTM as a combo therapy with Opdualag is anticipated
to elicit a greater therapeutic impact on cancer patients. With the study expected to be complete by the end of April 2023, Defence plans to finalize its IND filings through City of Hope National Medical Center and Beckman Research Institute by May 2023.