Defence Therapeutics Inc. announced that the excitement around AccuTOXTM against cancer continues to develop and expand its applications. The AccuTOXTM molecule can eradicate cancer cells via different mechanisms including the initiation of immunogenic cells death, endoplasmic reticulum stress and by causing direct damages to DNA. When tested in three different animal models of solid tumors (lymphoma, melanoma and breast), the compound-controlled tumor growth and synergized with different commercially-used immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47).

AccuTOXTM on Lung cancer, a completed pre-clinical study using Defence's intranasal formulation of AccuTOXTM in the context of animals with pre-established lung cancer showed that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals. This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination. AccuTOXTM anti -cancer, in preparation of its Phase I clinical trial using AccuTOXTM as an anti-cancer molecule and in recommendation by its collaborators at the City of Hope National Medical Center and Beckman Research Institute where the Phase I will be done, Defence conducted a preclinical study investigating two objectives: i) minimizing AccuTOXTM dosing to twice a week over a period of three weeks (for a total of 6 injections), and ii) combining AccuTOXTM with both anti-PD-1 and anti-LAG3, which is equivalent to the use of Opdualag (a BMS premixed combination of nivolumab and relatlimab) currently administered to cancer patients at City of Hope.

The strong results confirm that AccuTOXTM is suitable for any solid tumor, and it can synergise with a variety of immune-checkpoint inhibitors making it a future treatment of choice in immune-oncology. AccuTOXTM manufacturing Phase I, Biopeptek Pharmaceuticals, LLC, a renowned US based CDMO dedicated to the production of high-quality peptides for clinical applications, has optimized formulation and is finalizing manufacturing and packaging of the AccuTOXTM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements.

IND filling for Defence's Phase I clinical trial to treat melanoma patients at City of Hope,CA, USA will be done imminently. AccuTOXTM triggers cancer tumor regression, Defence also recently demonstrated that encapsulated AccuTOXTM with chitosan nanoparticles triggers complete tumor regression in animals with pre-established solid lymphoma. This additional discovery on AccuTOXTM is a simpler and cheaper method compared to the use of antibodies and may represent a key component of Defence's future encapsulation strategies and could revolutionize the future of molecular medicine by increasing the compounds specificity to tumor site while minimizing the needed dosage and thus, associated side effects.

AccuTOXTM patent portfolio is growing. Further development and expanding applications on Defence's leading AccuTOXTM therapeutic is. ongoing and further news to be released upon results.