TIDMBVX
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."
S
For more information, please contact:
BiVictriX Therapeutics plc
Tiffany Thorn, Chief Executive Officer
Michael Kauffman, Non-Executive Email: info@bivictrix.com
Chairman
SP Angel Corporate Finance LLP Tel: +44 (0) 20 3470 0470
(NOMAD and Broker)
David Hignell, Kasia Brzozowska
(Corporate Finance)
Vadim Alexandre, Rob Rees (Sales
and Broking)
Panmure Gordon (UK) Limited (Joint Tel: +44 (0) 20 7886 2500
Broker)
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
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(R) Antibody Drug Conjugate
therapeutics which are designed to selectively target
cancer-specific antigen pairs, or "Bi-Cygni(R) fingerprints", on
tumour cells, which are largely absent from healthy cells.
BiVictriX has established a growing proprietary library of
cancer-specific Bi-Cygni(R) fingerprints, which enable the Company
to target a diverse array of different cancer types. The Company
utilises these novel Bi-Cygni(R) 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.
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