DEFENCE THERAPEUTICS ACHIEVES A MAJOR MILESTONE AND BEGINS IND-ENABLING TESTING OF ITS ACCUTOX LEAD COMPOUND AGAINST BREAST CANCER

DGAP-News: Defence Therapeutics Inc. / Key word(s): Miscellaneous
10.01.2022 / 13:30
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DEFENCE THERAPEUTICS ACHIEVES A MAJOR MILESTONE AND BEGINS IND-ENABLING TESTING OF ITS ACCUTOX LEAD COMPOUND AGAINST BREAST CANCER

Vancouver, BC, Canada, January 10^th, 2022 - Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various immune-oncology products, is pleased to announce the start of its final step in GLP studies on its lead anti-cancer AccuTOX^TM molecule at Eurofins Advinus Limited prior to initiate its Phase I trial in breast cancer patients.

Eurofins Advinus Limited is a leading Drug Discovery and Development Contract Research Organization (CRO) with 30 years of experience testing regulated products under Good Laboratory Practice (GLP). With 400 employees, 80 full Preclinical IND packages completed and over 20,000 GLP Toxicology studies with the full range of required toxicology studies, Eurofins Advinus is one of the most experienced Drug Development Contract Research Organisation.

Eurofins has been mandated by Defence to complete all final GLP studies required by the FDA and Health Canada on its lead AccuTOX^TM molecule. The studies will be conducted on both rats (rodent) and dogs (non-rodents) to identify the maximum tolerated dose in addition to evaluate the pharmacokinetic and toxicology profile of the lead compound.

"We are pleased with our very efficient advancement in the AccuTOX^TM program. Not only did the Accum^TM elicit powerful anti-cancer properties, but in addition we screened a series of variants (>50) to identify the lead AccuTOX^TM molecule capable of efficiently killing more than 9 different tumor cell lines of both murine and human origin (lymphoma, melanoma, breast, colon and non-small cell lung carcinoma). Completing this set of GLP studies represents therefore the final step before approaching the FDA/Health Canada to initiate a Phase I trial in breast cancer patients in 2022", says Mr. Plouffe, the CEO of Defence.

According to Fortune Business Insights, the Global Breast Cancer Therapeutics Market, which stood at USD 17.8 Billion in 2018, will reach USD 38.5 Billion by the end of 2026, which would represent a CAGR of 10.2% between 2018 and 2026.

The pre-clinical studies conducted by the Defence team on mice revealed how potent is the Accum^TM molecule at inhibiting tumor cell growth both in vitro and in vivo. In addition, Accum^TM was shown to elicit additive effects in animals when used in conjunction with immune-checkpoint inhibitors such as CTLA-4 and PD-1, two antibodies currently being used in the oncology clinic to treat cancer patients.

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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