TIDMBVX
RNS Number : 8536P
BiVictriX Therapeutics PLC
12 October 2023
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or the "Company")
Extended survival rates reported with BVX001 in a pre-clinical
model of
Acute Myeloid Leukaemia
-- BVX001 increased survival rates in a difficult-to-treat
pre-clinical model of Acute Myeloid Leukaemia by 126% as compared
to untreated control.
-- These pre-clinical survival data build upon the recently
announced positive efficacy data with BVX001 that showed
statistically significant tumour regressions of up to 97%.
-- Taken together, these data significantly strengthen the
preclinical data package for BVX001, supporting IND-enabling
studies and accelerated progress towards the clinic .
Alderley Park, 12 October 2023 - BiVictriX Therapeutics plc
(AIM: BVX), an emerging biotechnology company applying a
differentiated approach to develop novel, next-generation precision
bispecific Antibody Drug Conjugates, offering substantially
improved cancer cell selectivity and therapeutic activity,
announces today that, BVX001, a first-in-class Bi-Cygni(R) antibody
drug conjugate ("ADC") for the treatment of Acute Myeloid Leukaemia
("AML"), significantly prolonged survival rates in an established
preclinical model of AML.
These survival results build on the positive pre-clinical murine
efficacy data announced in June 2023 . The study assessed BVX001 as
compared to HiDAC (the highest accepted dose of the clinically
approved AML chemotherapy drug Cytarabine ("Ara C"), only given to
the fittest patients for short periods due to extremely high
toxicity); together with an untreated control group (vehicle
only).
Following the 28-day dosing period and efficacy assessment, the
duration of survival post treatment was determined. Encouragingly,
the median survival rate observed in the BVX001 treatment group
(10mg/kg dosed twice weekly) was 129 days versus 91 days as
reported for the HiDAC treatment group, both calculated from
treatment initiation, as compared to 57 days for the untreated
control. This constitutes a median survival advantage for BVX001 of
126% versus untreated control and a median survival advantage of
42% versus HiDAC.
This preclinical model represents a more challenging model of
AML than is found in the clinic, with more cells able to drive
cancer progression than the limited number of specialised driver
cells (Leukaemia Initiating Cells ("LICs") or Leukaemia Stem Cells
("LSCs")) that are found in AML patients.
BVX001 extends median survival by 126%
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics
plc, said: "Acute Myeloid Leukaemia remains a significant unmet
medical need, linked to one of the poorest overall survival rates
across all cancers. All currently approved AML therapies are
associated with severely toxic side effects, including potentially
fatal infections and sepsis, limiting their use to younger, fitter
patients. We are greatly encouraged by this recent pre-clinical
data, demonstrating that BVX001 provides clear survival benefits,
even in this challenging AML model. This data adds further strength
to our existing and comprehensive pre-clinical data package, as we
accelerate work towards obtaining regulatory approval to support
the progression of BVX001 into human trials."
Jane Kendrew, Director of Translational Oncology at Sygnature
Discovery (contract research organisation that conducted the
study), added: "We have built a strong relationship with BiVictriX
and have had the pleasure of conducting all of their in vivo
efficacy models to date for BVX001. From our experience as a highly
reputable CRO for pre-clinical studies in the oncology space, and
from my own experience as a leader in translational oncology for
over 20 years, the efficacy data generated with BVX001 is amongst
the best we have reported in the AML setting. We look forward to
continuing to work closely with BiVictriX as they progress this
highly promising asset into the clinic."
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
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
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