BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

BiVictriX Hosts Inaugural Roundtable Discussion with Globally Renowned Experts to Appraise BVX001 as an Emerging, Differentiated Therapy for the Treatment of AML

·    Key Opinion Leader ("KOL") roundtable with four world-leading Acute Myeloid Leukemia ("AML") experts to review preclinical data and emerging clinical position of BiVictriX's lead asset, BVX001, a bispecific Antibody Drug Conjugate ("ADC") in the AML setting.

·    The expert group emphasised the significant unmet need in AML and the opportunity for improved therapeutic options, endorsing the potential of the CD7⁺/CD33⁺ targeting approach of BVX001 to approximately 30% of the patient population.

·    The potential activity of BVX001 against the leukaemic stem cell population was highlighted as significant, along with emerging data supporting activity against treatment failure and cancer recurrence.

·    BiVictriX will establish an AML Scientific Advisory Board in 2024 to assist in shaping a route to patients for BVX001.

Alderley Park, 04 January 2024 - BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a differentiated approach to develop novel, next-generation anti-cancer precision Antibody Drug Conjugates, offering substantially improved cancer cell selectivity and therapeutic activity, recently held an expert roundtable with four renowned Key Opinion Leaders ("KOL") in the acute myeloid leukaemia ("AML") space, to direct the Company's clinical development strategy for its lead asset, BVX001.

Attendees from across globally recognised research institutions in the US and UK included, Dr Naval G. Daver and Dr Courtney D. DiNardo, from the MD Anderson Cancer Center; Dr Dan Pollyea from the University of Colorado's School of Medicine; and Dr Emma Searle from The Christie (see below for full biographies). Attendees from BiVictriX included Tiffany Thorn, Chief Executive Officer; Adrian Howd, Chief Financial Officer and Chief Business Officer; Dr Oliver Schon, VP of R&D and Dr Michael Kauffman, Chairman.

Dr Dan Pollyea, Professor of Medicine-Haematology at the University of Colorado, commented: "BVX001 has a compelling preclinical profile in the AML setting and recent data supports the potential for CD7⁺ targeting approaches, as provided by BVX001, to address the poor response of this significant patient population to existing therapies. At this juncture, BVX001 shows promise and as a physician, I am keen to work more closely with the Company as they progress towards first-in-human studies."

Dr Naval Daver, Clinical Researcher in the Department of Leukaemia at the MD Andersen Cancer Center, added: "The immunophenotype targeted by BVX001 has been consistently shown to be present in approximately 30% of all AML patients. This represents a significant clinical and commercial opportunity in the disease setting where the unmet need remains high, and we are actively seeking better targeted therapeutics as treatment options."

Dr Courtney DiNardo, Clinical Researcher in the Department of Leukaemia at the MD Andersen Cancer Center, added: "The preclinical profile of BVX001 indicates the drug's potential to greatly reduce toxicities by sparing healthy cells. If this profile is consistent with clinical data from future studies, the drug will have the ability to more selectively and effectively target and kill AML-causing cells, whilst ensuring more patients can successfully receive therapy without treatment-limiting side effects."

Dr Emma Searle, Consultant Haematologist at the Christie, added: "The emerging profile of BVX001 suggests the Company will be able to utilise a currently accepted and clinically validated biomarker profile for AML patient selection. This should provide a lower risk clinical strategy and provide meaningful data more readily for both clinicians and patients."

Tiffany Thorn, CEO and Founder of BiVictriX, added: "Our inaugural KOL panel provided key insights into the emerging profile and optimal clinical path for BVX001. We are encouraged by the interest and validation of our approach and data to date in this area of high unmet medical need, and we will establish an AML Scientific Advisory Board in 2024 to further assist in shaping a route to patients for BVX001, as we progress to clinical studies. We will complete further preclinical work on BVX001 in early 2024, and are currently engaging with the FDA regarding a first in human study."

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  

About Naval G. Daver, MD

Dr Naval Daver is an Associate Professor in the Department of Leukemia at MD Anderson Cancer Center (MDACC), US. He is a clinical investigator with a focus on molecular and immune therapies in AML and Myelofibrosis, as well as principal investigator on >25 ongoing institutional, national and international clinical trials in these diseases. These trials focus on developing a personalized therapy approach by targeting specific mutations or immune pathways expressed by patients with AML, evaluating novel combinations of targeted, immune and cytotoxic agents, and identifying and overcoming mechanism of resistance. Dr Daver is especially interested in developing monoclonal and bispecific antibodies, immune checkpoint and vaccine based approaches in AML, MDS, and myelofibrosis and is leading a number of these trials at MDACC. Dr Daver has published >150 peer-reviewed manuscripts and is on the editorial board of numerous haematology specific journals. He has also authored numerous abstracts at national and international conferences.

About Courtney D. DiNardo, MD, MSCE

Dr Courtney DiNardo is a clinical researcher at the Department of Leukaemia at the MD Andersen Cancer Center, US, with a specialized focus on prognostication and personalized therapeutics for patients with myeloid malignancies. She has completed formal training in epidemiology and biostatistics and is the primary investigator of multiple novel IDH1 or IDH2-targeted therapeutic agents currently in clinical trials and is also involved in the clinical development of the BCL2-inhibitor venetoclax (ABT-199) for myeloid malignancies. Dr DiNardo is leading the study of venetoclax in combination with hypomethylating agent therapy for the treatment of newly diagnosed elderly AML patients. In addition, Dr DiNardo's clinical and research focus pertaining to hereditary cancer predisposition syndromes has led to the development of the MD Anderson Hereditary Hematologic Malignancy Clinic, which now provides clinical and research-based evaluation of underlying cancer predispositions and hereditary cancer syndromes in leukaemia patients.

About Dan Pollyea, MD, MS

Dr Daniel Pollyea is Professor of Medicine-Haematology at the University of Colorado's School of Medicine, US, and currently serves as the Chair of the National Comprehensive Cancer Network Guidelines Committee on AML, having acted as Principal Investigator for multiple early-phase clinical trials and been involved in the clinical development and approval of four drugs for AML. His work involves developing ways to target leukaemia stem cells in patients with AML and myelodysplastic syndrome (MDS), resulting in the identification of vulnerabilities in the ways that leukaemia stem cells process energy. These weaknesses can be specifically exploited with novel drug therapies, and Dr Pollyea is focused on developing and running clinical trials that use these agents to target these weaknesses.

About Emma Searle, MBChB, MA, MRCP, FRCPath, PhD

Dr Emma Searle currently serves as a consultant haematologist at The Christie Hospital, UK, having been appointed in mid-2020. She specialises in the set up and delivery of early phase clinical trials of new anti-cancer drugs, including first in human trials, for patients with haematological malignancies and has a particular interest in early phase clinical trials for older patients with blood cancer. Prior to this, Dr Searle was awarded a Cancer Research UK-AstraZeneca PhD fellowship in 2010 to research the role of a novel molecularly targeted cancer therapy when given alongside radiotherapy and, on completion of her PhD in 2016, Dr Searle was appointed as an NIHR Clinical Lecturer at the University on Manchester to further develop her research interests alongside completion of clinical training.