BVX.L Regulatory News (BVX)

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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

Extended survival rates reported with BVX001 in a pre-clinical model of

Acute Myeloid Leukaemia

· BVX001 increased survival rates in a difficult-to-treat pre-clinical model of Acute Myeloid Leukaemia by 126% as compared to untreated control.

· These pre-clinical survival data build upon the recently announced positive efficacy data with BVX001 that showed statistically significant tumour regressions of up to 97%.

· Taken together, these data significantly strengthen the preclinical data package for BVX001, supporting IND-enabling studies and accelerated progress towards the clinic.

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. 

BVX001 extends median survival by 126%

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.

Find out more about BiVictriX online at www.bivictrix.com