BiVictriX Therapeutics plc announced that, BVX001, a first-in-class Bi-Cygni ADC for the treatment of Acute Myeloid Leukaemia ("AML"), showed a favourable toxicity profile in an industry standard toxicology model. These data add to the positive safety and efficacy data for BVX001 announced in 2023. This repeat dose-range finding pre-clinical study assessed the tolerability, toxicity and toxicokinetics of BVX001 at 10, 30 and 55mg/kg.

It also assessed standard behavioural and clinical endpoints (including haematology and serum chemistry), and macro/microscopic changes in a comprehensive range of organs and tissues.Converted to human equivalent doses, the doses tested for safety in this study were up to 11-times higher than equivalent doses used in a mouse xenograft model that showed significant tumour regressions in a hard-to-treat AML tumour model. BVX001 was tolerated across the dose-range with adverse clinical and anatomic pathology changes primarily observed only at the high dose level. Toxicokinetic analysis demonstrated dose-proportional systemic exposures that did not accumulate after repeated administration.

The data from the study will be submitted for formal presentation at the forthcoming American Society of Haematology meeting in December 2024.