BVX-001

Alderley Park, 12 October 2023 ‐ BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a differentiated approach to develop novel, next-generation precision bispecific Antibody Drug Conjugates, offering substantially improved cancer cell selectivity and therapeutic activity, announces today that, BVX001, a first-in-class Bi-Cygni® antibody drug conjugate (“ADC”) for the treatment of Acute Myeloid Leukaemia (“AML”), significantly prolonged survival rates in an established preclinical model of AML. These survival results build on the positive pre-clinical murine efficacy data announced in June 2023. The study assessed BVX001 as compared to HiDAC (the highest accepted dose of the clinically approved AML chemotherapy drug Cytarabine (“Ara C”), only given to the fittest patients for short periods due to extremely high toxicity); together with an untreated control group (vehicle only). Following the 28-day dosing period and efficacy assessment, the duration of survival post treatment was determined. Encouragingly, the median survival rate observed in the BVX001 treatment group (10mg/kg dosed twice weekly) was 129 days versus 91 days as reported for the HiDAC treatment group, both calculated from treatment initiation, as compared to 57 days for the untreated control. This constitutes a median survival advantage for BVX001 of 126% versus untreated control and a median survival advantage of 42% versus HiDAC. This preclinical model represents a more challenging model of AML than is found in the clinic, with more cells able to drive cancer progression than the limited number of specialised driver cells (Leukaemia Initiating Cells (“LICs”) or Leukaemia Stem Cells (“LSCs”)) that are found in AML patients. Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, said: “Acute Myeloid Leukaemia remains a significant unmet medical need, linked to one of the poorest overall survival rates across all cancers. All 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 recent pre-clinical data, demonstrating that BVX001 provides clear survival benefits, even in this challenging AML model. This data adds further strength to our existing and comprehensive pre-clinical data package, as we accelerate work towards obtaining regulatory approval to support the progression of BVX001 into human trials.” Jane Kendrew, Director of Translational Oncology at Sygnature Discovery (contract research organisation that conducted the study), added: “We have built a strong relationship with BiVictriX and have had the pleasure of conducting all of their in vivo efficacy models to date for BVX001. From our experience as a highly reputable CRO for pre-clinical studies in the oncology space, and from my own experience as a leader in translational oncology for over 20 years, the efficacy data generated with BVX001 is amongst the best we have reported in the AML setting. We look forward to continuing to work closely with BiVictriX as they progress this highly promising asset into the clinic.” 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.

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.” 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. 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. 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.