REG - BiVictriX Therapcts. - BiVictriX Hosts Inaugural Roundtable Discussion

Bivictrix TherapeuticsAnnouncement

04/01/2024 07:00

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RNS Number : 5731Y  BiVictriX Therapeutics PLC  04 January 2024

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."

 

 ENDS

 For more information, please contact:

BiVictriX Therapeutics plc
 Tiffany Thorn, Chief Executive Officer

 Michael Kauffman, Non-Executive Chairman             Email: info@bivictrix.com (mailto:info@bivictrix.com)

 SP Angel Corporate Finance LLP (NOMAD and Broker)      Tel: +44 (0) 20 3470 0470
 David Hignell, Kasia Brzozowska (Corporate Finance)

 Vadim Alexandre, Rob Rees (Sales and Broking)

 Panmure Gordon (UK) Limited (Joint Broker)             Tel: +44 (0) 20 7886 2500
 Rupert Dearden/Freddy Crossley/Emma Earl

 ICR Consilium
 Mary-Jane Elliott, Namrata Taak,                     Tel: +44 (0) 20 3709 5700

 Max Bennett, Emmalee Hoppe                           Email: Bivictrix@consilium-comms.com (mailto:Bivictrix@consilium-comms.com)

 

 

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
(http://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.

 

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