THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED
UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014
WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL)
ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA
A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO
BE IN THE PUBLIC DOMAIN.
BIVICTRIX
THERAPEUTICS PLC
("BiVictriX" or the "Company")
Compelling Safety Profile of
BVX001 in Pre-Clinical Models Supports Progression to Clinic
·
BVX001 showed an
in vivo safety profile
supporting progression to final IND-enabling studies and towards
clinical studies
·
Toxicological profile
compares favourably to other FDA approved ADCs with the same linker
and cytotoxic payload
·
Importantly, ocular toxcity
was not observed at mid to low doses, and affects at higher doses
were graded as minimal
·
No severe pathological
changes seen at all doses tested with marked observations only in
the higher dose groups
·
These data significantly
strengthen the preclinical data package for BVX001, informing
clincial dose selection
·
Data will be submitted for
presentation at the 2024 meeting of the American Society of
Haematology
Alderley Park, 13 June 2024 -
BiVictriX Therapeutics plc (AIM: BVX), a drug discovery and
development company applying an innovative, proprietary approach to
develop a new class of highly selective, next generation
cancer therapeutics, bispecific antibody drug conjugates
(Bi-Cygni® ADCs),
which exhibit superior potency, whilst eliminating
treatment-related toxicities, announces today that, BVX001, a
first-in-class Bi-Cygni® ADC for the treatment of Acute Myeloid
Leukaemia ("AML"), showed a favourable toxicity profile in an
industry standard toxicology model.
These data add to the positive safety and
efficacy data for BVX001 announced in 2023. This repeat dose-range
finding pre-clinical study assessed the tolerability, toxicity and
toxicokinetics of BVX001 at 10, 30 and 55mg/kg. It also assessed
standard behavioural and clinical endpoints (including haematology
and serum chemistry), and macro/microscopic changes in a
comprehensive range of organs and tissues.
Converted to human equivalent doses, the doses
tested for safety in this study were up to 11-times higher than
equivalent doses used in a mouse xenograft model that showed
significant tumour regressions in a hard-to-treat AML tumour
model.
BVX001 was tolerated across the dose-range with
adverse clinical and anatomic pathology changes primarily observed
only at the high dose level. Toxicokinetic analysis demonstrated
dose-proportional systemic exposures that did not accumulate after
repeated administration. The data from the study will
be submitted for formal presentation at the forthcoming American
Society of Haematology meeting in December 2024.
Tiffany Thorn,
Chief Executive Officer of BiVictriX Therapeutics plc,
said: "The
need for more effective therapies to treat Acute Myeloid Leukaemia
is clear and 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 toxicology data which compares
favourably to data from ADCs with similar cytotoxic paylods. This
data rounds out our comprehensive pre-clinical data package, as we
accelerate the key workstreams necessary to obtain regulatory
approval to support the progression of BVX001 into human
trials."
ENDS
For
more information, please contact:
BiVictriX
Therapeutics plc
|
|
|
Tiffany Thorn, Chief Executive
Officer
Michael Kauffman, Non-Executive
Chairman
|
Email: info@bivictrix.com
|
|
|
|
|
SP Angel
Corporate Finance LLP (NOMAD and Broker)
|
Tel: +44 (0)
20 3470 0470
|
|
David Hignell, Kasia Brzozowska (Corporate
Finance)
Vadim Alexandre, Rob Rees (Sales and
Broking)
|
|
|
Panmure Gordon (UK) Limited (Joint Broker)
|
Tel: +44 (0)
20 7886 2500
|
|
Rupert Dearden/Freddy Crossley/Emma
Earl
ICR
Consilium
|
|
|
Mary-Jane Elliott, Namrata Taak,
Max Bennett, Emmalee Hoppe
|
Tel: +44 (0) 20 3709
5700
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® Antibody Drug Conjugate therapeutics which are designed
to selectively target cancer-specific antigen pairs, or "Bi-Cygni®
fingerprints", on tumour cells, which are largely absent from
healthy cells.
BiVictriX has established a growing
proprietary library of cancer-specific Bi-Cygni® fingerprints,
which enable the Company to target a diverse array of different
cancer types. The Company utilises these novel Bi-Cygni®
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