Biotechnology company Defence Therapeutics has announced the start of its final step in GLP studies on its anti-cancer AccuTOXTM molecule at Eurofins Advinus Limited prior to initiating its Phase 1 trial in breast cancer patients.
Eurofins Advinus Limited is a leading Drug Discovery and Development Contract Research Organisation (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 CROs.
Eurofins has been mandated by Defence Therapeutics 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 evaluating the pharmacokinetic and toxicology profile of the lead compound.
The AccuTOXTM program
“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 nine different tumour 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″, said Sébastien Plouffe, the CEO of Defence.
According to Fortune Business Insights, the Global Breast Cancer Therapeutics Market, which stood at $17.8bn in 2018, will reach $38.5bn by the end of 2026, which would represent a CAGR of 10.2% between 2018 and 2026.
The preclinical studies conducted by the Defence Therapeutics team on mice revealed how potent is the AccumTM molecule at inhibiting tumour 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.
