REG - BiVictriX Therapcts. - Positive final data in preclinical efficacy study

Bivictrix TherapeuticsAnnouncement

17/07/2023 07:00

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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® 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® 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
(https://bivictrix.com/news/positive-interim-data-in-second-preclinical-efficacy-study/)
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,
(https://bivictrix.com/news/bivictrix-nominates-clinical-candidate-for-bvx001/)
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 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

 

 Consilium Strategic Communications

 Mary-Jane Elliott, Namrata Taak, Genevieve Wilson, Max Bennett, Emmalee Hoppe  Tel: +44 (0) 20 3709 5700

                                                                                Email: Bivictrix@consilium-comms.com (mailto: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®
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 (http://www.bivictrix.com) and connect with
us on LinkedIn (https://www.linkedin.com/company/bivictrix-therapeutics-plc/)
and Twitter @BiVictriX (https://twitter.com/BiVictriX) .

 

About Bi-Cygni® ADCs

BiVictriX is pioneering a fundamentally differentiated approach to generate a
proprietary pipeline of Bi-Cygni® ADCs through the identification and
targeting of previously undiscovered cancer-specific antigen pairs -
or "Bi-Cygni® fingerprints" - alongside cutting-edge protein engineering
expertise in the design of precision therapeutics. Bi-Cygni® 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® 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® 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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