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BiVictriX Therapeutics plc

("BiVictriX", "BiVictriX Therapeutics" or the "Company")

BiVictriX Reports Positive Initial In Vivo Data from BVX002 Solid Tumour Programme

·      First in vivo data shared from BVX002, BiVictriX's lead solid tumour bispecific ADC programme

·      Complete tumour growth inhibition and tumour regressions observed at well-tolerated doses in a murine model of ovarian cancer

Alderley Park, 9 September 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 reducing treatment-related toxicities, today announces positive initial in vivo data for its lead solid tumour programme, BVX002.

The preclinical study is investigating BVX002 in a murine xenograft model of ovarian cancer, using the human cell line OVCAR-3. Initial data reported highly significant tumour growth inhibitions across all doses tested, ranging from 78.3% to >100% (p-value <0.001). Tumour regressions of up to 63.1% were also observed at the mid and high doses.

During the study, BVX002 was dosed once weekly, with a total of four doses given. All doses of BVX002, including the highest dose tested, were well tolerated in all mice, even with the drug having target cross-reactivity in mice. Following completion of the dosing phase, monitoring of tumour volume post dosing continues. It is noted that the tumours have continued to shrink in the mid to high dose arms two weeks post treatment cessation, highlighting the potential durability of BVX002's anti-cancer effects. This data builds upon the strong preclinical in vivo efficacy and safety data previously reported on our most advanced bispecific ADC asset, BVX001. 

BVX002 targets a novel, cancer-specific antigen pair found to be selectively expressed in a wide range of solid tumour indications, including cases of ovarian cancer and non-small cell lung cancer, but is absent from healthy cells. Evidence from internal data assessing primary patient samples suggests BVX002's targeted cancer-specific antigen pair may be present in 60-70% of patients with high grade serous ovarian cancer.

In June 2024, BiVictriX announced the awarding of a ca.£0.4 million grant from Innovate UK to help support this preclinical work with BVX002. The Company will use insights from this study, together with additional planned studies, to file an Investigational New Drug (IND) Application with the FDA for BVX002 in due course.

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, commented: "This first in vivo data marks the start of what we anticipate being an incredibly exciting preclinical data package for our lead solid tumour asset, BVX002. We are highly encouraged by the significance of the anti-tumour effect delivered by our therapeutic lead in this hard-to-treat model of ovarian cancer, which showcases the clear benefit of our proprietary bispecific ADC approach in a solid tumour setting. We look forward to providing further updates as we expedite the development of this asset." 

Graph 2: Bodyweight Change for BVX002-treated and Control Groups

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 ("Bi-Cygni®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.