REG - BiVictriX Therapcts. - Positive interim data

Bivictrix TherapeuticsAnnouncement

19/06/2023 07:00

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RNS Number : 0772D  BiVictriX Therapeutics PLC  19 June 2023

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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company" or the "Group")

Positive interim data in second preclinical efficacy study

·    At day 18, BVX001 induced highly statistically significant tumour
regressions of 89% (p-value <0.001) in a second murine efficacy study of
Acute Myeloid Leukaemia (AML) where the tumours were established at a much
larger size (~650mm(3))

·    Builds upon recently announced positive preclinical efficacy data
that showed highly statistically significant tumour regressions of up to 93%

 

Alderley Park, 19 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 positive interim data from a
second in vivo efficacy study of its lead programme, BVX001, a first-in-class
Bi-Cygni® antibody drug conjugate (ADC) for the treatment of Acute Myeloid
Leukaemia (AML).

BiVictriX reports highly statistically significant tumour regressions in a
murine model of AML in which tumours were established at a larger size
(~650mm(3)). The efficacy study, which is due for completion before the end of
June, is assessing the anti-tumour responses of our nominated clinical
candidate of BVX001 at a dose of 10mg/kg twice weekly. Interim data from the
study shows that BVX001 demonstrated 89% tumour regression (p-value
<0.001***) at day 18 following administration of six out of the total eight
planned doses of BVX001. An untreated animal group was used as a negative
control in the study.

These results follow the recently announced
(https://bivictrix.com/news/bivictrix-nominates-clinical-candidate-for-bvx001/)
(6 June) preclinical efficacy data which showed that our nominated clinical
candidate of BVX001 induced highly statistically significant tumour
regressions of up to 93% in a murine model of AML, with tumours averaging
200mm(3) in size at the start of the study.

In this study, the AML tumours were established at a much larger size prior to
dosing, 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. This new data shows
that BVX001 retains its potent anti-tumour activity even in the more difficult
setting, with no observed adverse effects.

Having recently nominated the clinical candidate for the BVX001 programme,
this positive data further strengthens the preclinical data package for BVX001
and signifies the potential of the Company's lead therapeutic asset in
treating patients with AML.

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc,
commented: "The highly statistically significant tumour regression observed in
large tumours treated with BVX001, from our second in vivo efficacy study,
provides further evidence of our lead asset's potential for targeting patients
with challenging-to-treat cancers. In a short space of time, we have built a
comprehensive preclinical data package, with each new data set providing
additional validation of our Bi-Cygni® therapeutic approach, moving us one
step closer to the clinic and offering additional options for future expansion
into other indications. We are moving expeditiously to advance BVX001 into
human trials and are laying the groundwork for future manufacturing, clinical
and commercialisation activities."

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® 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.

 

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, 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 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 (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.

 

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