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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

Positive final data in second preclinical efficacy study

·    At day 28, BVX001 induced highly statistically significant tumour regressions of 97% (p-value <0.001) in a murine efficacy study of Acute Myeloid Leukaemia (AML) where the tumours were established at a large size (~650mm³)

·    These results expand upon the recently announced positive interim preclinical efficacy data from the same study that showed highly statistically significant tumour regressions of 89% (p-value <0.001) at day 18

·    In addition, United States Patent and Trademark Office issues a Notice of Allowance for an initial broad patent for BVX001 in the United States

Alderley Park, 17 July 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 final data from a second in vivo efficacy study of its lead clinical candidate BVX001, a first-in-class Bi-Cygni® antibody drug conjugate (ADC) for the treatment of Acute Myeloid Leukaemia (AML).

The objective of this 28-day study, conducted in a murine model of AML, was to assess the anti-tumour responses of BVX001 at a dose of 10mg/kg twice weekly in a more challenging setting where tumours were established at a large size (~650mm³). Final data at day 28 showed that BVX001 induced highly statistically significant tumour regressions of 97% (p-value <0.001***), following administration of all eight scheduled doses of BVX001. An animal group dosed with vehicle only was used as a negative control in the study.

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, commented: "Following on from the positive interim data reported at day 18 from this in vivo efficacy study,  I am delighted to announce that BVX001 continued to deliver highly statistically significant tumour regressions in this model, reaching 97% by day 28 (p<0.001). This is very encouraging data, as many anti-cancer agents perform less favourably in larger tumours, due to reduced drug penetration. These strong results demonstrate that BVX001 retains its potent anti-tumour activity even in a more difficult setting, whilst showcasing the effectiveness of our Bi-Cygni® approach. These results will form part of the comprehensive preclinical data package that we are building to pave the way for advancing BVX001 into human trials."

BVX001 induces significant tumour regressions in a large tumour murine model of AML

These final results build upon the interim preclinical efficacy data announced on 19 June 2023, which demonstrated highly statistically significant tumour regressions for BVX001 of up to 89% at day 18, following six out of the total eight planned doses of BVX001.

In this study, the AML tumours were established at a much larger size when compared to a first preclinical efficacy study, announced on 6 June 2023. Tumours in this second study averaged 650mm³ prior to dosing, as compared to 200mm³, 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. These final data demonstrate that BVX001 retains its potent anti-tumour activity even in this more difficult setting, with no observed adverse effects.

Together, these in vivo efficacy studies make up a strong preclinical data package for the BVX001 programme, demonstrating the significant potential of the Company's lead therapeutic asset in treating patients with AML.

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

Intellectual Property Update

In support of the Company's development plans for advancing BVX001 towards the clinic, BiVictriX also announces that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance, wherein USPTO has agreed to issue a patent which provides broad protection for the Company's lead asset, BVX001, in the United States. It is anticipated that the patent claims will be granted in the United States within the coming months.

The Company is also in the process of securing intellectual property protection in a further seven global territories to provide broad protection for BVX001 across all relevant markets. 

Ends

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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 efficacy with substantially improved cancer-selectivity and safety to provide opportunities for prolonged dosing and greater efficacy in the clinic. 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.

About BVX001

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.