Vancouver, British Columbia–(October 18, 2023) – Defence Therapeutics Inc. (CSE:DTC) (FSE:DTC) (OTC Pink:DTCFF) (“Defence” or the “Company“), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to announce 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.
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.
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6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management’s expectations regarding Defence Therapeutics Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Defence Therapeutics Inc.’s industry; (b) market opportunity; (c) Defence Therapeutics Inc.’s business plans and strategies; (d) services that Defence Therapeutics Inc. intends to offer; (e) Defence Therapeutics Inc.’s milestone projections and targets; (f) Defence Therapeutics Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Defence Therapeutics Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Defence Therapeutics Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Defence Therapeutics Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Defence Therapeutics Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) the accuracy of budgeted costs and expenditures; (e) Defence Therapeutics Inc.’s ability to attract and retain skilled personnel; (f) political and regulatory stability; (g) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (h) changes in applicable legislation; (i) stability in financial and capital markets; and (j) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Defence Therapeutics Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Defence Therapeutics Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Defence Therapeutics Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Defence Therapeutics Inc.’s business operations (e) Defence Therapeutics Inc. may be unable to implement its growth strategy; and (f) increased competition.
Except as required by law, Defence Therapeutics Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Defence Therapeutics Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Defence Therapeutics Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.
7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of Defence Therapeutics Inc. or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of Defence Therapeutics Inc. or such entities and are not necessarily indicative of future performance of Defence Therapeutics Inc. or such entities.
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