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BIVICTRIX THERAPEUTICS PLC

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

BiVictriX nominates clinical candidate for BVX001  

·    BVX001 clinical candidate achieved statistically significant tumour regressions of up to 93% (p-value <0.001) with good tolerability in a murine model of Acute Myeloid Leukaemia (AML),

·    Results further strengthen preclinical data package for BVX001, supporting progress towards the clinic

Alderley Park, 6 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 the nomination of a clinical candidate for its lead BVX001 programme, following strong in vivo efficacy data. The data showed significant tumour regressions with no observed adverse effects in a murine model of Acute Myeloid Leukaemia ("AML"). Of note, and as previously reported on 31 January 2023, BVX001, a first-in-class Bi-Cygni® antibody drug conjugate (ADC), has been associated with superior cancer cell selectivity and safety versus the currently available anti-AML ADC Mylotarg® (gemtuzumab ozogamicin), when evaluated in a murine toxicity model assessing the risk of neutropenia (low numbers of infection-fighting white blood cells).

The four-week study aimed to assess the efficacy of two development leads, a lead and a back-up, of BVX001 (BVX001-1 and BVX001-2) alongside an untreated negative control group (vehicle only) and very high doses of Cytarabine, or "Ara C", a clinically approved AML chemotherapy drug that can only be given at this dose to medically "fit" patients with AML for very short periods. Three dosing regimens were evaluated for each development lead: 10mg/kg dosed twice weekly, 10mg/kg dosed once weekly, and 3mg/kg dosed twice weekly for 28 days.

All BVX001 dosing regimens resulted in a highly statistically significant (p-value <0.001) tumour growth inhibition of >87% at day 28, when compared to the untreated negative control group. At a dosing of 10mg/kg twice weekly, both development leads yielded a highly statistically significant (p-value <0.001) tumour regression at day 28 of 93% and 89%, respectively. All doses were well-tolerated. The highly statistically significant regressions in tumour volume reported with each development lead dosed at 10mg/kg twice weekly are shown in the graph below.  

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, commented: "This strong in vivo efficacy data we are seeing from our first clinical candidate provides clear validation for our first-in-class Bi-Cygni® therapeutics and their potential to provide much-needed further treatment options for patients with Acute Myeloid Leukaemia, one of the most aggressive forms of cancer. By identifying novel cancer-specific "Bi-Cygni® fingerprints", such as the one used for BVX001, we are seeing superior cancer cell selectivity, improving the overall effectiveness of the therapy by potentially significantly reducing toxicities and thereby offering the potential to give larger doses of treatment to patients for longer durations, to result in better outcomes. We will continue to progress BVX001 through further preclinical studies towards obtaining regulatory approval to initiate human trials, while seeking suitable third-party partnerships to support manufacturing and clinical development activities as well as commercialisation of the asset."

This announcement follows the identification of a development lead for BiVictriX's BVX001 programme in December 2022, which was taken forward into several in vivo studies. A highly favourable bone marrow safety profile for BVX001 versus Mylotarg® was announced in January 2023.

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 leukaemic cells amongst 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.

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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 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.