Defence Therapeutics has announced a pivotal milestone: the U.S. Food and Drug Administration (FDA) has granted a green light with a “Study May Proceed” status for its Investigational New Drug (IND) application.
This FDA approval is specifically for a Phase I clinical trial of ACCUM-002TM Dimer CDCA-SV40, popularly known as AccuTOX®, an injectable anticancer molecule targeting solid cancer tumours.
Introducing AccuTOX®: A revolutionary anticancer molecule
AccuTOX®, a derivative of the initial Accum® backbone molecule, has been meticulously engineered to disrupt various cellular processes, inducing genotoxic effects and stimulating immunogenic cell death.
Preclinical studies conducted under the supervision of Dr Moutih Rafei, Defence’s CSO, have demonstrated promising outcomes, including impaired tumour growth and notable complete responses in 70% of treated animals afflicted with T-cell lymphoma, melanoma, or breast cancer.
Groundbreaking FDA approval for Defence’s flagship therapy
The recent FDA approval marks a significant stride for Defence Therapeutics as AccuTOX® emerges as the company’s pioneering first-in-class therapy in the realm of immune oncology.
This accomplishment underscores Defence’s commitment to pioneering innovation in the field of anticancer therapeutics.
The filing and safety review protocol is entitled ‘Phase 1 trial of ACCUM-002TM administered intratumorally as monotherapy and in combination with Opdualag (fixed IV doses), in patients with unresectable, stage IIIB to IV melanoma refractory to or relapse from standard therapy’.
Strategic significance of the FDA approval
The successful filing and subsequent safety review of Defence’s protocol by the FDA is a pivotal achievement in the company’s strategic agenda, boasting a diverse pipeline of therapies.
AccuTOX®, alongside the array of cancer vaccine-related treatments, is slated to become the cornerstone asset in Defence’s portfolio dedicated to combating cancer.
Objectives of the Phase I Clinical Trial
The primary goal of the imminent Phase I clinical trial is to establish the safest dosing range for co-administering AccuTOX® with Opdulag®, a BMS product featuring anti-LAG3 and anti-PD-1 components.
The trial will closely monitor various secondary parameters, including therapeutic efficacy, in treated patients. These efforts are in preparation for a Phase II clinical trial encompassing a broader spectrum of tumours. Further details regarding the Phase I trial initiation will be disclosed shortly.
Mission and vision of Defence Therapeutics
Remaining steadfast in its mission to address unmet clinical needs, Defence Therapeutics is unwavering in its pursuit to establish itself as a global leader in the development of cutting-edge anticancer therapies.
This milestone reinforces the company’s dedication to innovating and revolutionising cancer treatment methodologies.
Commenting on the achievement, Sébastien Plouffe, President & CEO of Defence Therapeutics, said: “We are very proud, thrilled, and we look forward to beginning this Phase I trial as its aim is to test one of our leads and most advanced therapeutic candidate for the treatment of solid tumours for the benefits of the cancer patients. Defence is becoming a clinical-stage company.”
