BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) said its lead drug candidate, BVX001, showed a compelling safety profile in preclinical tests, paving the way for clinical trials.
BVX001 is a next-generation treatment, called an antibody drug conjugate (ADC), designed to target acute myeloid leukaemia (AML) more precisely and effectively while reducing harmful side effects.
In tests, BVX001 showed no severe eye damage at low to moderate doses and only minimal effects at higher doses. Overall, there were no severe tissue changes across all tested doses, with noticeable effects only at the highest dose levels.
Indeed, the toxicological profile of BVX001 compared favourably to other FDA-approved ADCs with similar drug payloads
This promising safety data makes BVX001 a strong candidate for further development, guiding how much of the drug can be safely given to patients. The data will be presented at the American Society of Hematology meeting in December.
The study tested BVX001 at three different dose levels: low, medium, and high. It looked at how well the drug was tolerated, any toxic effects, and how it behaved in the body over time. The doses tested were much higher than those used in earlier studies on mice, which had shown significant tumour reduction.
BVX001 was generally well-tolerated, with most side effects appearing only at the highest dose. The study also found that the drug levels in the body were proportional to the dose given, and did not build up over time with repeated use.
"The need for more effective therapies to treat acute myeloid leukaemia is clear and currently approved AML therapies are associated with severely toxic side effects, including potentially fatal infections and sepsis, limiting their use to younger, fitter patients," said BiVictriX CEO Tiffany Thorn.
"We are greatly encouraged by this toxicology data which compares favourably to data from ADCs with similar cytotoxic paylods.
"This data rounds out our comprehensive pre-clinical data package, as we accelerate the key workstreams necessary to obtain regulatory approval to support the progression of BVX001 into human trials."