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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

Compelling Safety Profile of BVX001 in Pre-Clinical Models Supports  Progression to Clinic    

·    BVX001 showed an in vivo safety profile supporting progression to final IND-enabling studies and towards clinical studies

·    Toxicological profile compares favourably to other FDA approved ADCs with the same linker and cytotoxic payload

·    Importantly, ocular toxcity was not observed at mid to low doses, and affects at higher doses were graded as minimal

·    No severe pathological changes seen at all doses tested with marked observations only in the higher dose groups

·    These data significantly strengthen the preclinical data package for BVX001, informing clincial dose selection

·    Data will be submitted for presentation at the 2024 meeting of the American Society of Haematology

Alderley Park, 13 June 2024 - BiVictriX Therapeutics plc (AIM: BVX), a drug discovery and development company applying an innovative, proprietary approach to develop a new class of highly selective, next  generation cancer therapeutics, bispecific antibody drug conjugates (Bi-Cygni® ADCs), which exhibit superior potency, whilst eliminating treatment-related toxicities, announces today 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.

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, said: "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. 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."

About BiVictriX Therapeutics plc

BiVictriX is a UK-based drug discovery and development company which is focused on leveraging clinical experience to develop a new class of highly selective, next generation cancer therapeutics which exhibit superior potency, whilst significantly reducing treatment-related toxicities.

The Company utilises a first-in-class approach to generate a proprietary pipeline of Bi-Cygni® Antibody Drug Conjugate therapeutics which are designed to selectively target cancer-specific antigen pairs, or "Bi-Cygni® fingerprints", on tumour cells, which are largely absent from healthy cells.

BiVictriX has established a growing proprietary library of cancer-specific Bi-Cygni® fingerprints, which enable the Company to target a diverse array of different cancer types. The Company utilises these novel Bi-Cygni® fingerprints, together with the Company's novel Antibody Drug Conjugate therapeutic design, to develop more effective and safer therapeutics to target cancers that are expected to constitute orphan indications and areas of high unmet medical need.

Find out more about BiVictriX online at www.bivictrix.com