DEFENCE TO COMPLETE A FINAL PRE-CLINICAL STUDY PRIOR TO IND FILINGS FOR THE ACCUTOXTM PHASE I CANCER TRIAL AT THE CITY OF HOPE NATIONAL MEDICAL CENTER AND BECKMAN RESEARCH INSTITUTE

EQS-News: Defence Therapeutics Inc. / Key word(s): Miscellaneous
DEFENCE TO COMPLETE A FINAL PRE-CLINICAL STUDY PRIOR TO IND FILINGS FOR THE ACCUTOXTM PHASE I CANCER TRIAL AT THE CITY OF HOPE NATIONAL MEDICAL CENTER AND BECKMAN RESEARCH INSTITUTE
28.03.2023 / 08:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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CSE: DTC  FSE: DTC  USOTC: DTCFF  PRESS RELEASE

DEFENCE TO COMPLETE A FINAL PRE-CLINICAL STUDY PRIOR TO IND FILINGS FOR THE ACCUTOX^TM PHASE I CANCER TRIAL AT THE CITY OF HOPE NATIONAL MEDICAL CENTER AND BECKMAN RESEARCH INSTITUTE

Vancouver, BC, Canada, March 28^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 that it is currently conducting a final pre-clinical study aimed at validating the efficacy of AccuTOX^TM combined to immune-checkpoint inhibitors akin to the clinical design to be used on patients to be enrolled in the Phase I cancer clinical trial planned at the City of Hope National Medical Center and Beckman Research Institute.       

Defence has completed all required pre-clinical and GLP studies on its lead compound AccuTOX^TM as an injectable for solid tumors. The Defence team has shown that tumors are effectively controlled following intratumoral administration of AccuTOX^TM three times per week in combination with anti-PD-1, anti-CTLA4 or anti-CD47. Dr. Yan Xing, who will conduct Defence’s Phase I cancer clinical trial at City of Hope National Medical Center and Beckman Research Institute, is a physician, oncologist that has a Ph.D. in biostatistics from the University of Texas, a fellowship in medical oncology from the Houston Methodist Hospital as well as a fellowship in Phase I clinical trials from the MD Andersen Cancer Center. Dr. Yan Xing strives to improve cancer treatment and outcomes through rigorous data analyses to better determine which practices work best. Under Dr. Xing recommendations, Defence will perform a preclinical study whereas the treatment will be twice a week over a three-week period.  

Defence’s AccuTOX^TM ongoing pre-clinical study has implemented a plan to be closely matched as the Phase I cancer clinical trial. AccuTOX^TM will be delivered twice a week over a total period of three weeks. This study plan would significantly decrease the number of hospital visits per week for cancer patients. The AccuTOX^TM will be delivered as combination therapy with both anti-PD-1 and anti-LAG3. The latter immune-checkpoint inhibitor combination is similar to the use of Opdualag (a BMS premixed combination of nivolumab and relatlimab), which is currently being administered to cancer patients at the City of Hope National Medical Center and Beckman Research Institute.

"The ongoing in vivo study will highlight potential potency differences using a different administration regimen and in addition it may determine this novel combination that can further enhance the therapeutic potency of AccuTOX^TM" says Mr. Plouffe, CEO and president of Defence.            

Clinical studies have shown that the use of Opdualag has doubled the median progression-free survival of patients with advanced melanoma. The AccuTOX^TM as a combo therapy with Opdualag is anticipated to elicit a greater therapeutic impact on cancer patients. With the study expected to be complete by the end of April 2023, Defence plans to finalize its IND filings through City of Hope National Medical Center and Beckman Research Institute by May 2023.

Data Bridge Market Research analyses that the solid tumors market was valued at USD 209.61 billion in 2021 and is expected to reach USD 901.27 billion by 2029, registering a CAGR of 20.0% during the forecast period of 2022 to 2029.

https://www.databridgemarketresearch.com/reports/global-solid-tumors-market    

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

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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