TIDMBVX
RNS Number : 7185B
BiVictriX Therapeutics PLC
06 June 2023
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or the "Company" or the "Group")
BiVictriX nominates clinical candidate for BVX001
-- BVX001 clinical candidate achieved statistically significant
tumour regressions of up to 93% (p-value <0.001) with good
tolerability in a murine model of Acute Myeloid Leukaemia (
AML),
-- Results further strengthen preclinical data package for
BVX001, supporting progress towards the clinic
Alderley Park, 6 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 the nomination of a clinical candidate for its
lead BVX001 programme, following strong in vivo efficacy data. The
data showed significant tumour regressions with no observed adverse
effects in a murine model of Acute Myeloid Leukaemia ("AML"). Of
note, and as previously reported on 31 January 2023 , BVX001, a
first-in-class Bi-Cygni(R) antibody drug conjugate (ADC), has been
associated with superior cancer cell selectivity and safety versus
the currently available anti-AML ADC Mylotarg(R) (gemtuzumab
ozogamicin), when evaluated in a murine toxicity model assessing
the risk of neutropenia (low numbers of infection-fighting white
blood cells).
The four-week study aimed to assess the efficacy of two
development leads, a lead and a back-up, of BVX001 (BVX001-1 and
BVX001-2) alongside an untreated negative control group (vehicle
only) and very high doses of Cytarabine, or "Ara C", a clinically
approved AML chemotherapy drug that can only be given at this dose
to medically "fit" patients with AML for very short periods. Three
dosing regimens were evaluated for each development lead: 10mg/kg
dosed twice weekly, 10mg/kg dosed once weekly, and 3mg/kg dosed
twice weekly for 28 days.
All BVX001 dosing regimens resulted in a highly statistically
significant (p-value <0.001) tumour growth inhibition of >87%
at day 28, when compared to the untreated negative control group.
At a dosing of 10mg/kg twice weekly, both development leads yielded
a highly statistically significant (p-value <0.001) tumour
regression at day 28 of 93% and 89%, respectively. All doses were
well-tolerated. The highly statistically significant regressions in
tumour volume reported with each development lead dosed at 10mg/kg
twice weekly are shown in the graph below.
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics
plc, commented: "This strong in vivo efficacy data we are seeing
from our first clinical candidate provides clear validation for our
first-in-class Bi-Cygni(R) therapeutics and their potential to
provide much-needed further treatment options for patients with
Acute Myeloid Leukaemia, one of the most aggressive forms of
cancer. By identifying novel cancer-specific "Bi-Cygni(R)
fingerprints", such as the one used for BVX001, we are seeing
superior cancer cell selectivity, improving the overall
effectiveness of the therapy by potentially significantly reducing
toxicities and thereby offering the potential to give larger doses
of treatment to patients for longer durations, to result in better
outcomes. We will continue to progress BVX001 through further
preclinical studies towards obtaining regulatory approval to
initiate human trials, while seeking suitable third-party
partnerships to support manufacturing and clinical development
activities as well as commercialisation of the asset."
This announcement follows the identification of a development
lead for BiVictriX's BVX001 programme in December 2022 , which was
taken forward into several in vivo studies. A highly favourable
bone marrow safety profile for BVX001 versus Mylotarg(R) was
announced in January 2023 .
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 leukaemic cells amongst 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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