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Defence Therapeutics Awarded Broad U.S. Patent Covering Its Pioneering Cancer-Killing AccuTOX(R) Technology

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Defence Therapeutics Inc. receives US patent for its breakthrough AccuTOX technology, providing market exclusivity until 2042. The technology induces cancer cell death and shows promising results in pre-clinical studies, leading to FDA approval for Phase I clinical trials in melanoma patients.
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Vancouver, British Columbia--(Newsfile Corp. - March 4, 2024) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce 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. 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.

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 includes seven published patent families.

About Defence:
Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:
Sebastien Plouffe, President, CEO and Director
P: (514) 947-2272
Splouffe@defencetherapeutics.com
www.defencetherapeutics.com

Cautionary Statement Regarding "Forward-Looking" Information

This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/200050

FAQ

What patent was granted to Defence Therapeutics Inc.?

Defence Therapeutics Inc. was granted US patent no. 11,890,350 for its breakthrough AccuTOX technology.

What does the '350 patent cover?

The '350 patent covers a portfolio of therapeutically-active molecules making up the AccuTOX platform, providing potential market exclusivity until late 2042.

What is the basis of the AccuTOX platform?

The AccuTOX platform is based on the discovery that certain bile acid-peptide conjugates induce cancer cell death by triggering heightened metabolic stress and the production of reactive oxygen species.

What types of cancer cells has AccuTOX shown effectiveness against?

AccuTOX has shown effectiveness against lung, breast, colon, melanoma, and lymphoma cancer cells in vitro, and has demonstrated significant solid tumor growth reductions in pre-clinical studies.

What is the status of Defence's Phase I clinical trial for AccuTOX?

Defence has received FDA approval to commence its Phase I clinical trial to evaluate the effect of intratumoral administration of AccuTOX as a monotherapy and in combination with Opdualag in patients with unresectable stage IIIB to IV melanoma.

DEFENCE THERAPEUTICS A

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