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DEFENCE MANUFACTURING ITS ARM VACCINE IN PREPARATION FOR PHASE I CLINICAL TRIAL AGAINST SOLID TUMORS

Vancouver, BC, Canada, February 6^th 2023 - Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies is pleased to announce the start of its ARM vaccine manufacturing in preparation of its Phase I clinical trial targeting patients with solid cancer tumors.

Defence is continuously striving to exploit its Accum^TM technology in many verticals. Defence demonstrated that Accum^TM has the capacity to enhance biomedicine’s accumulation in target cells and the Accum^TM molecule can be modified and enhanced to behave as an anti-cancer drug, AccuTOX^TM. The most recent discovery of the Defence team is that Accum^TM can be engineered to reprogram mesenchymal stromal cells, which are naturally immune-suppressive, into antigen-presenting cells capable of mounting potent anti-cancer responses which lead to the ARM vaccine.  

"Today marks another important infliction point for Defence as the production of its ARM vaccine in preparation for its Phase I clinical trial to treat solid cancer tumors. This success is two-fold: the use of a novel type of stem cell never applied before in the design of cancer vaccine combined to a new function discovered for our Accum^TM platform technology", says Mr. Plouffe, CEO and President of Defence Therapeutics.

The roadmap to Phase I

In collaboration with Allucent, Defence is currently preparing its application to Health Canada to initiate its Phase I clinical trial in 2023. Meanwhile, the final pre-clinical studies, supervised by Dr. Rafei, Defence’s VP – Research and Development, are currently being conducted to identify the best dosing regimen (cell dose, timing of administration and routing). In parallel, GMP-grade human cells are currently being expanded in a GLP cell processing facility at the Lady Davis Institute cell processing center, Montreal, Canada, to conduct the dry runs required by Health Canada prior to Phase I clinical trial approval. These studies consist of assessing the expansion potential of cells as well as the time required to generate enough cellular doses to treat all enrolled patients. Various quality control studies related to antigen capture, processing and presentation will be validated to ensure reproducibility of the different ARM vaccine batches generated from various unrelated healthy donors. Once the Master and Working cell banks established via these runs, cancer cell lysates obtained from patients will be prepared, characterized and stored accordingly for ARM vaccine pulsing.  

"I have always looked at mesenchymal stromal cells from a different angle, an angle different from the mainstream use of these cells. This study will not only provide new hope for cancer patients, but it may provide a solution to a decade-old problem related to the design of anti-cancer cell vaccines" adds Dr. Rafei, the VP - Research and Development of Defence Therapeutics.

The completion of the dry runs along with all required quality control steps is to be expected by mid-spring. Defence will then meet with Health Canada to obtain permission for its Phase I clinical trial, with the objective to beginning it in 2023. Once the Phase I clinical trial will be completed, this universal off-the-shelf ARM vaccine could be adapted to accommodate patients with various cancer tumor types.            

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^TM 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

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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.

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