On July 24, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that its Canadian Nuclear Research Initiative Health ("CNRI-H") Program application was retained and approved by the Canadian Nuclear Laboratories ("CNL") to accelerate Defence’s radio-immuno-conjugates project (Press release, Defence Therapeutics, JUL 24, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-granted-cnri-h-from-the-canadian-nuclear-laboratories-to-accelerate-the-development-of-its-radio-immuno-conjugates-program [SID1234645036]).

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Defence’s CNRI-H project will focus on the synthesis and evaluation of novel constructs, variations of 111In-AccuTOX-Trastuzumab. The objective is to demonstrate that AccuTOX moiety is an essential modification to conventional 111In-Trastuzumab constructs to evade an endosome entrapment and ensure nuclear localization, where 111In will emit Auger Electrons ("AEs") to kill cancer cells, and providing a synergistic effect by unleashing AccuTOX immune-boosting power. It is expected that these constructs will be lethal to HER2-positive cancer cells specifically and will produce high potency.

Selected AccuTOX constructs, based on stability, solubility, and biochemical properties, will be conjugated to the trastuzumab antibody, followed by radiolabeled with 111In, and then characterized, in vitro and in vivo, for its efficacy in killing cancer. The main goal is to identify the biologically active 111In-AccuTOX-Trastuzumab molecule that will be more potent to treat solid tumor resistant to current HER2-targeting therapy such as therapeutic antibodies (e.g., trastuzumab alone) and antibody-drug conjugate (e.g., Kadcyla).

In summary, the aim of this CNRI-H collaborative project is:

1. To synthesize AccuTOX-Trastuzumab antibody conjugates, radiolabel with 111In, and characterize, including structure and cellular analysis (e.g. identification, drug-antibody ratio, specific activity), stability, and cytotoxic effects, in vitro.

2. To perform animal studies in rodents, in vivo, namely biodistribution, pharmacokinetic profile, and therapeutic potency, using selected 111In-AccuTOX-Trastuzumab constructs.

"We are proud to have this opportunity to collaborate with the Canadian Nuclear Laboratories and to advancing Defence’s radio-immuno-conjugates program for the benefit of the cancer’s patients. The CNL scientific team dedicated to our project is very strong and will definitely accelerate and reinforce Defence’s strength in this renowned and fast-growing radiopharmaceuticals field," said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

CNRI-H is a program developed by CNL to further the realization of its mission of contributing to the health of Canadians. Through CNRI-H, CNL provides financial support along with its expertise, experience, capabilities and makes this available and accessible to the healthcare community to advance new life saving radiopharmaceutical solutions. CNRI-H is a turnkey solution that integrates both funding and project execution in one award. The goal of the program is to accelerate the optimization of therapeutic isotopes production and the clinical translation of targeted radiopharmaceuticals for the benefit of Canadians whilst increasing the safety and efficacy of therapies that involve radiopharmaceuticals.

According to Allied Market Research, the global radiopharmaceuticals market was valued at $7.9 billion in 2023, and is projected to reach $21.8 billion by 2033, growing at a CAGR of 10.6% from 2024 to 2033. And according to Straits Research, the global radioligand therapy market size was valued at USD 12.55 billion in 2023, and it is anticipated to reach USD 21.55 billion by 2032 with a CAGR of 4.62%. The use of radioligands to treat specific cancers is a novel method. It delivers radiation to cancer cells with pinpoint accuracy and minimal side effects on healthy cells, resulting in higher treatment efficacy.