TIDMBVX
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BiVictriX Therapeutics PLC
19 June 2023
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or the "Company" or the "Group")
Positive interim data in second preclinical efficacy study
-- At day 18, BVX001 induced highly statistically significant
tumour regressions of 89% (p-value <0.001) in a second murine
efficacy study of Acute Myeloid Leukaemia (AML) where the tumours
were established at a much larger size (650mm(3) )
-- Builds upon recently announced positive preclinical efficacy
data that showed highly statistically significant tumour
regressions of up to 93%
Alderley Park, 19 June 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 interim data from a second in vivo
efficacy study of its lead programme, BVX001, a first-in-class
Bi-Cygni(R) antibody drug conjugate (ADC) for the treatment of
Acute Myeloid Leukaemia (AML).
BiVictriX reports highly statistically significant tumour
regressions in a murine model of AML in which tumours were
established at a larger size (650mm(3) ). The efficacy study, which
is due for completion before the end of June, is assessing the
anti-tumour responses of our nominated clinical candidate of BVX001
at a dose of 10mg/kg twice weekly. Interim data from the study
shows that BVX001 demonstrated 89% tumour regression (p-value
<0.001***) at day 18 following administration of six out of the
total eight planned doses of BVX001. An untreated animal group was
used as a negative control in the study.
Th ese results follow the recently announced (6 June)
preclinical efficacy data which showed that our nominated clinical
candidate of BVX001 induced highly statistically significant tumour
regressions of up to 93% in a murine model of AML, with tumours
averaging 200mm (3) in size at the start of the study.
In this study, the AML tumours were established at a much larger
size prior to dosing, 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. This new data shows that BVX001
retains its potent anti-tumour activity even in the more difficult
setting, with no observed adverse effects.
Having recently nominated the clinical candidate for the BVX001
programme, this positive data further strengthens the preclinical
data package for BVX001 and signifies the potential of the
Company's lead therapeutic asset in treating patients with AML.
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics
plc, commented: "The highly statistically significant tumour
regression observed in large tumours treated with BVX001, from our
second in vivo efficacy study, provides further evidence of our
lead asset's potential for targeting patients with
challenging-to-treat cancers. In a short space of time, we have
built a comprehensive preclinical data package, with each new data
set providing additional validation of our Bi-Cygni(R) therapeutic
approach, moving us one step closer to the clinic and offering
additional options for future expansion into other indications. We
are moving expeditiously to advance BVX001 into human trials and
are laying the groundwork for future manufacturing, clinical and
commercialisation activities."
Full results from this in vivo efficacy study will be submitted
for publication and presented at an upcoming scientific
conference.
BVX001 is a first-in-class Bi-Cygni(R) 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.
Ends
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
Consilium Strategic Communications
Mary-Jane Elliott, Namrata Taak, Tel: +44 (0) 20 3709 5700
Genevieve Wilson, Emmalee Hoppe Email: Bivictrix@consilium-comms.com
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(R) 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(R) ADCs
BiVictriX is pioneering a fundamentally differentiated approach
to generate a proprietary pipeline of Bi-Cygni(R) ADCs through the
identification and targeting of previously undiscovered
cancer-specific antigen pairs - or "Bi-Cygni(R) fingerprints" -
alongside cutting-edge protein engineering expertise in the design
of precision therapeutics. Bi-Cygni(R) 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(R) 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.
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