On March 4, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, reported the granting of US patent no. 11,890,350 (‘350) by the United States Patent and Trademark Office (USPTO), broadly covering its breakthrough AccuTOX technology (Press release, Defence Therapeutics, MAR 4, 2024, https://defencetherapeutics.com/defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology/?utm_source=rss&utm_medium=rss&utm_campaign=defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology [SID1234640729]). The ‘350 patent, which includes valuable composition-of-matter claims covering a portfolio of therapeutically-active molecules making up the AccuTOX platform, provides Defence with potential market exclusivity until late 2042.
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The AccuTOX platform is based on the discovery that certain bile acid-peptide conjugates, in their free forms, induce cancer cell death by triggering heightened metabolic stress and the production of reactive oxygen species. The ‘350 patent demonstrates that the bile acid-peptide conjugates, when used past cytotoxic threshold concentrations, can potently induce cell death in multiple tumor cells in vitro, including lung, breast, colon, melanoma, and lymphoma cancer cells, and can dramatically reduce lymphoma tumor volumes and enhance survival in vivo in treated mice compared to controls.
Defence’s ‘350 patent was issued with broad claims encompassing a plurality of AccuTOX molecules having cytotoxic or cytostatic activity, either as a monotherapy or in combination with other therapeutics. The granted claims also cover AccuTOX molecules releasably conjugated to a variety of carrier molecules, such as cancer-specific antibodies, where AccuTOX effectively plays the role of a cytotoxic drug, thereby pioneering a potentially new class of next-generation antibody-drug conjugates (ADCs).
Stemming from the data published in the ‘350 patent, pre-clinical and GLP studies for AccuTOX, either alone or in combination with immune checkpoint inhibitors such as anti-PD-1 and anti-LAG3, were undergone, and have shown that the compound is safe and well tolerated using both rodents and canine animal models, and have also demonstrated significant solid tumor growth reductions. Subsequently, Defence has now received FDA approval to commence its Phase I clinical trial to evaluate the effect of intratumoral administration of AccuTOX as a monotherapy, as well as in combination with Opdualag (fixed IV doses), in patients with unresectable stage IIIB to IV melanoma refractory to or relapse from standard therapy.
"The rapid granting of the broad ‘350 patent by the USPTO affirms the innovative and groundbreaking potential of AccuTOX as a leading cancer therapeutic, and also importantly provides a long patent runway and period of market exclusivity for Defence to fully explore the commercial potential of the AccuTOX platform and maximize the benefit to our partners and investors," says Mr. Plouffe, CEO and president of Defence.
This patent marks the fourth granted US patent in Defence’s ever-growing patent portfolio, which currently incudes seven published patent families.