TIDMBVX
RNS Number : 1461G
BiVictriX Therapeutics PLC
17 July 2023
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or the "Company")
Positive final data in second preclinical efficacy study
-- At day 28, BVX001 induced highly statistically significant
tumour regressions of 97% (p-value <0.001) in a murine efficacy
study of Acute Myeloid Leukaemia (AML) where the tumours were
established at a large size (650mm(3) )
-- These results expand upon the recently announced positive
interim preclinical efficacy data from the same study that showed
highly statistically significant tumour regressions of 89% (p-value
<0.001) at day 18
-- In addition, United States Patent and Trademark Office issues
a Notice of Allowance for an initial broad patent for BVX001 in the
United States
Alderley Park, 17 July 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 final data from a second in vivo
efficacy study of its lead clinical candidate BVX001, a
first-in-class Bi-Cygni(R) antibody drug conjugate (ADC) for the
treatment of Acute Myeloid Leukaemia (AML).
The objective of this 28-day study, conducted in a murine model
of AML, was to assess the anti-tumour responses of BVX001 at a dose
of 10mg/kg twice weekly in a more challenging setting where tumours
were established at a large size (650mm(3) ). Final data at day 28
showed that BVX001 induced highly statistically significant tumour
regressions of 97% (p-value <0.001***), following administration
of all eight scheduled doses of BVX001. An animal group dosed with
vehicle only was used as a negative control in the study.
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics
plc, commented: "Following on from the positive interim data
reported at day 18 from this in vivo efficacy study, I am delighted
to announce that BVX001 continued to deliver highly statistically
significant tumour regressions in this model, reaching 97% by day
28 (p<0.001). This is very encouraging data, as many anti-cancer
agents perform less favourably in larger tumours, due to reduced
drug penetration. These strong results demonstrate that BVX001
retains its potent anti-tumour activity even in a more difficult
setting, whilst showcasing the effectiveness of our Bi-Cygni(R)
approach. These results will form part of the comprehensive
preclinical data package that we are building to pave the way for
advancing BVX001 into human trials."
BVX001 induces significant tumour regressions in a large tumour
murine model of AML
These final results build upon the interim preclinical efficacy
data announced on 19 June 2023, which demonstrated highly
statistically significant tumour regressions for BVX001 of up to
89% at day 18, following six out of the total eight planned doses
of BVX001.
In this study, the AML tumours were established at a much larger
size when compared to a first preclinical efficacy study, announced
on 6 June 2023. Tumours in this second study averaged 650mm(3)
prior to dosing, as compared to 200mm(3) , 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. These final data
demonstrate that BVX001 retains its potent anti-tumour activity
even in this more difficult setting, with no observed adverse
effects.
Together, these in vivo efficacy studies make up a strong
preclinical data package for the BVX001 programme, demonstrating
the significant potential of the Company's lead therapeutic asset
in treating patients with AML.
Final results from this in vivo efficacy study will be submitted
for publication and presented at an upcoming scientific
conference.
Intellectual Property Update
In support of the Company's development plans for advancing
BVX001 towards the clinic, BiVictriX also announces that the United
States Patent and Trademark Office ("USPTO") has issued a Notice of
Allowance, wherein USPTO has agreed to issue a patent which
provides broad protection for the Company's lead asset, BVX001, in
the United States. It is anticipated that the patent claims will be
granted in the United States within the coming months.
The Company is also in the process of securing intellectual
property protection in a further seven global territories to
provide broad protection for BVX001 across all relevant
markets.
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, Max Bennett, Emmalee Email: Bivictrix@consilium-comms.com
Hoppe
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 efficacy with substantially
improved cancer-selectivity and safety to provide opportunities for
prolonged dosing and greater efficacy in the clinic. 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.
About BVX001
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.
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