REG - BiVictriX Therapcts. - Compelling Safety Profile of BVX001

Bivictrix TherapeuticsAnnouncement

13/06/2024 07:00

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RNS Number : 2923S  BiVictriX Therapeutics PLC  13 June 2024

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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 (mailto: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,                     Tel: +44 (0) 20 3709 5700

 Max Bennett, Emmalee Hoppe                           Email: Bivictrix@consilium-comms.com (mailto: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
(http://www.bivictrix.com/)

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