THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED.  ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company" or the "Group")

Positive interim data in second preclinical efficacy study

·    At day 18, BVX001 induced highly statistically significant tumour regressions of 89% (p-value <0.001) in a second murine efficacy study of Acute Myeloid Leukaemia (AML) where the tumours were established at a much larger size (~650mm³)

·    Builds upon recently announced positive preclinical efficacy data that showed highly statistically significant tumour regressions of up to 93%

Alderley Park, 19 June 2023 - BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a differentiated approach to develop next-generation cancer therapies with substantially improved cancer cell selectivity and anti-cancer activity, announces positive interim data from a second in vivo efficacy study of its lead programme, BVX001, a first-in-class Bi-Cygni® antibody drug conjugate (ADC) for the treatment of Acute Myeloid Leukaemia (AML).

BiVictriX reports highly statistically significant tumour regressions in a murine model of AML in which tumours were established at a larger size (~650mm³). The efficacy study, which is due for completion before the end of June, is assessing the anti-tumour responses of our nominated clinical candidate of BVX001 at a dose of 10mg/kg twice weekly. Interim data from the study shows that BVX001 demonstrated 89% tumour regression (p-value <0.001***) at day 18 following administration of six out of the total eight planned doses of BVX001. An untreated animal group was used as a negative control in the study. 

These results follow the recently announced (6 June) preclinical efficacy data which showed that our nominated clinical candidate of BVX001 induced highly statistically significant tumour regressions of up to 93% in a murine model of AML, with tumours averaging 200mm³ in size at the start of the study.

In this study, the AML tumours were established at a much larger size prior to dosing, making any anti-tumour responses more significant. Of note, in larger tumour models such as this, many anti-cancer agents perform less favourably than in small tumours due to reduced drug penetration. This new data shows that BVX001 retains its potent anti-tumour activity even in the more difficult setting, with no observed adverse effects.

Having recently nominated the clinical candidate for the BVX001 programme, this positive data further strengthens the preclinical data package for BVX001 and signifies the potential of the Company's lead therapeutic asset in treating patients with AML.

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, commented: "The highly statistically significant tumour regression observed in large tumours treated with BVX001, from our second in vivo efficacy study, provides further evidence of our lead asset's potential for targeting patients with challenging-to-treat cancers. In a short space of time, we have built a comprehensive preclinical data package, with each new data set providing additional validation of our Bi-Cygni® therapeutic approach, moving us one step closer to the clinic and offering additional options for future expansion into other indications. We are moving expeditiously to advance BVX001 into human trials and are laying the groundwork for future manufacturing, clinical and commercialisation activities."

Full results from this in vivo efficacy study will be submitted for publication and presented at an upcoming scientific conference.

BVX001 is a first-in-class Bi-Cygni® ADC engineered to target the cancer-specific twin antigen fingerprint of CD7⁺CD33⁺, which is present only on the leukaemic cancer cells enabling them to be selectively targeted, while leaving healthy white blood cells, and other healthy tissues, alone. This cancer-specific fingerprint is found on the leukaemic cells in approximately 15-30% of patients with AML, and in subpopulations of patients with other haematological cancers, but is rarely detected on normal white blood cells or other normal cell populations.  This permits selective targeting of cancer cells while leaving infection-fighting white blood cells alone, aiming to significantly reduce treatment-related mortality linked to sepsis, while potentially providing more effective cancer treatment with improved long-term survival.

Ends

For more information, please contact:

About BiVictriX Therapeutics plc

BiVictriX (AIM: BVX) is an emerging biotechnology company leveraging clinical experience and its proprietary discovery engine to advance a new class of highly cancer-selective, next-generation precision cancer therapies in one of the fastest-growing markets in oncology. BiVictriX's first-in-class Bi-Cygni® Antibody Drug Conjugates (ADCs) combine superior cancer-selectivity and efficacy with significantly improved safety. The Company is advancing its pipeline to deliver the future of cancer care across a broad range of haematological and solid cancer indications in areas of high unmet medical need.

Find out more at www.bivictrix.com and connect with us on LinkedIn and Twitter @BiVictriX.

About Bi-Cygni® ADCs

BiVictriX is pioneering a fundamentally differentiated approach to generate a proprietary pipeline of Bi-Cygni® ADCs through the identification and targeting of previously undiscovered cancer-specific antigen pairs - or "Bi-Cygni® fingerprints" - alongside cutting-edge protein engineering expertise in the design of precision therapeutics. Bi-Cygni® fingerprints are present on cancer cells but are largely absent from healthy cells which infers a substantially improved patient safety profile when compared to most current cancer treatment options. Due to their enhanced cancer-selectivity, Bi-Cygni® ADCs offer the opportunity for a game-changing approach to cancer treatment, with the potential to vastly improve outcomes for patients and their families across a broad spectrum of cancer indications.