REG - BiVictriX Therapcts. - Positive In Vivo Data from BVX002 Programme

Bivictrix TherapeuticsAnnouncement

09/09/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240909:nRSI3289Da&default-theme=true

RNS Number : 3289D  BiVictriX Therapeutics PLC  09 September 2024

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 as it forms part of UK domestic law by virtue of
the European Union (Withdrawal) Act 2018. With the publication of this
announcement via a Regulatory Information Service, this inside information is
now considered to be in the public domain.

 

NOT FOR PUBLICATION OR RELEASE IN OR INTO THE UNITED STATES OR AUSTRALIA,
CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF IRELAND OR THE REPUBLIC OF SOUTH
AFRICA, OR ANY PROVINCE OR TERRITORY THEREOF OR TO OR FOR THE ACCOUNT OF ANY
NATIONAL, RESIDENT OR CITIZEN OF THE UNITED STATES OR ANY PERSON RESIDENT IN
AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF IRELAND OR THE REPUBLIC
OF SOUTH AFRICA.

 

BiVictriX Therapeutics plc

 

("BiVictriX", "BiVictriX Therapeutics" or the "Company")

 

BiVictriX Reports Positive Initial In Vivo Data from BVX002 Solid Tumour
Programme

 

·      First in vivo data shared from BVX002, BiVictriX's lead solid
tumour bispecific ADC programme

·      Complete tumour growth inhibition and tumour regressions
observed at well-tolerated doses in a murine model of ovarian cancer

 

Alderley Park, 9 September 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 reducing treatment-related toxicities, today
announces positive initial in vivo data for its lead solid tumour programme,
BVX002.

 

The preclinical study is investigating BVX002 in a murine xenograft model of
ovarian cancer, using the human cell line OVCAR-3. Initial data reported
highly significant tumour growth inhibitions across all doses tested, ranging
from 78.3% to >100% (p-value <0.001). Tumour regressions of up to 63.1%
were also observed at the mid and high doses.

 

During the study, BVX002 was dosed once weekly, with a total of four doses
given. All doses of BVX002, including the highest dose tested, were well
tolerated in all mice, even with the drug having target cross-reactivity in
mice. Following completion of the dosing phase, monitoring of tumour volume
post dosing continues. It is noted that the tumours have continued to shrink
in the mid to high dose arms two weeks post treatment cessation, highlighting
the potential durability of BVX002's anti-cancer effects. This data builds
upon the strong preclinical in vivo efficacy and safety data previously
reported on our most advanced bispecific ADC asset, BVX001.

 

BVX002 targets a novel, cancer-specific antigen pair found to be selectively
expressed in a wide range of solid tumour indications, including cases of
ovarian cancer and non-small cell lung cancer, but is absent from healthy
cells. Evidence from internal data assessing primary patient samples suggests
BVX002's targeted cancer-specific antigen pair may be present in 60-70% of
patients with high grade serous ovarian cancer.

 

In June
(https://bivictrix.com/news/bivictrix-announces-innovate-uk-grant-award-to-accelerate-solid-tumour-targeting-adc-pipeline/)
2024, BiVictriX announced the awarding of a ca.£0.4 million grant from
Innovate UK to help support this preclinical work with BVX002. The Company
will use insights from this study, together with additional planned studies,
to file an Investigational New Drug (IND) Application with the FDA for BVX002
in due course.

 

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc,
commented: "This first in vivo data marks the start of what we anticipate
being an incredibly exciting preclinical data package for our lead solid
tumour asset, BVX002. We are highly encouraged by the significance of the
anti-tumour effect delivered by our therapeutic lead in this hard-to-treat
model of ovarian cancer, which showcases the clear benefit of our proprietary
bispecific ADC approach in a solid tumour setting. We look forward to
providing further updates as we expedite the development of this asset."

 

 

Graph 1: Mean Tumour Volume Over Time for BVX002-treated and Control Groups

 

Graph 2: Bodyweight Change for BVX002-treated and Control Groups

 

 

ENDS

 

For more information, please contact:

 BiVictriX Therapeutics plc

 Tiffany Thorn, Chief Executive Officer                         Email: info@bivictrix.com

 Michael Kauffman, Non-Executive Chairman

 SP Angel Corporate Finance LLP (NOMAD and Broker)
 David Hignell, Caroline Rowe (Corporate Finance)

Vadim Alexandre, Rob Rees (Sales and Broking)                Tel: +44 (0) 20 3470 0470

 Panmure Liberum Limited (Joint Broker)
 Emma Earl, Freddy Crossley, Mark Rogers, Rupert Dearden

                                                               Tel: +44 (0) 20 3100 2000

 ICR Consilium

 Namrata Taak, Lucy Featherstone, Max Bennett, Emmalee Hoppe   Tel: +44 (0) 20 3709 5700

                                                               Email: 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 ("Bi-Cygni®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) .

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESSSUFAAELSEDU