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

On January 10, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various immune-oncology products, is pleased to reported the start of its final step in GLP studies on its lead anti-cancer AccuTOXTM molecule at Eurofins Advinus Limited prior to initiate its Phase I trial in breast cancer patients (Press release, Defence Therapeutics, JAN 10, 2022, View Source [SID1234626245]).

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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 AccuTOXTM 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 AccuTOXTM program. Not only did the AccumTM elicit powerful anti-cancer properties, but in addition we screened a series of variants (>50) to identify the lead AccuTOXTM molecule capable of efficiently killing more than 9 different tumor cell lines of both murine and human origin (lymphoma, melanoma, breast, colon and nonsmall 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 AccumTM molecule at inhibiting tumor cell growth both in vitro and in vivo. In addition, AccumTM 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.