Mr. Sebastien Plouffe reports

DEFENCE'S SUCCESSFUL SUBMISSION OF AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR ACCUTOX AS AN INJECTABLE ANTICANCER TREATMENT FOR SOLID TUMORS

Defence Therapeutics Inc. successfully submitted on Nov. 9, 2023, an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Accum-002 Dimer CDCA-SV40 (commonly named AccuTox), an injectable anti-cancer molecule, for the treatment of solid cancer tumours.

AccuTox is a derivative of the initial Accum molecule, which has been reported to target cancer on multiple fronts. AccuTox disrupts endosomal membranes, resulting in impaired intracellular transport mechanisms. AccuTox also triggers genotoxic effects, blocks DNA repair mechanisms normally used by cancer cells to repair its damaged genome and induces a form of immunogenic cell death capable of turning on the immune system. When previously tested in preclinical animal models under the supervision of Dr. Moutih Rafei, AccuTox impaired tumour growth, resulting in 70-per-cent to 100-per-cent survival of animals with solid T-cell lymphoma, melanoma or breast cancer.

The IND application includes data, reports and overview summaries of numerous studies to evaluate the pharmacology, pharmacokinetics and toxicology of AccuTox both in vitro and in vivo, including cancer models. In addition, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the FDA the extensive non-clinical data supporting an acceptable safety profile when AccuTox will be first administered to humans. The FDA will review the application and determine the acceptability of the data before Defence begins the phase I clinical trial, which could be as early as Q1 to Q2 2024.

"We are thrilled and excited that Defence has achieved a successful submission on its first IND, which represents an important milestone towards advancing AccuTox into the clinic. We look forward to work with clinical investigators at City of Hope to study this important and novel candidate for the treatment of melanoma and potentially other solid tumours," said Sebastien Plouffe, president and chief executive officer of Defence Therapeutics. "With the continued difficulties encountered in the oncology clinic, we believe that the therapeutic use of AccuTox provides a novel and powerful approach to combat cancer," he added.

The primary objective of this coming phase I clinical trial, when approved, is to identify the best therapeutic dosing range that would allow clinicians to co-administer the AccuTox compound with Opdulag, a BMS (Bristol Myers Squibb) product containing both anti-LAG3 and anti-PD-1. Several other secondary parameters, including therapeutic efficacy, will be monitored in treated patients in preparation for a phase IIa trial on a basket of tumours.

According to Precedence Research, the global cancer therapeutics market size is expected to be worth around $393.61-billion (U.S.) by 2032 from at $164-billion (U.S.) in 2022, growing at a CAGR (compound annual growth rate) of 9.20 per cent during the forecast period 2023 to 2032.

About Defence Therapeutics Inc.

Defence Therapeutics is a publicly traded biotechnology company working on engineering the next-generation vaccines and ADC (antibody drug conjugate) products using its proprietary platform. The core of Defence Therapeutics platform is the Accum 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 illnesses such as cancer and infectious diseases.

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