REG - BiVictriX Therapcts. - BiVictriX nominates clinical candidate for BVX001

Bivictrix TherapeuticsAnnouncement

06/06/2023 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:20230606:nRSF7185Ba&default-theme=true

RNS Number : 7185B  BiVictriX Therapeutics PLC  06 June 2023

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" or the "Group")

BiVictriX nominates clinical candidate for BVX001

·    BVX001 clinical candidate achieved statistically significant tumour
regressions of up to 93% (p-value <0.001) with good tolerability in a
murine model of Acute Myeloid Leukaemia (AML),

·    Results further strengthen preclinical data package for BVX001,
supporting progress towards the clinic

 

Alderley Park, 6 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 the nomination of a clinical
candidate for its lead BVX001 programme, following strong in vivo efficacy
data. The data showed significant tumour regressions with no observed adverse
effects in a murine model of Acute Myeloid Leukaemia ("AML"). Of note, and as
previously reported on 31 January 2023
(https://bivictrix.com/news/bivictrix-announces-positive-data-from-preclinical-study-of-bvx001/)
, BVX001, a first-in-class Bi-Cygni® antibody drug conjugate (ADC), has been
associated with superior cancer cell selectivity and safety versus the
currently available anti-AML ADC Mylotarg® (gemtuzumab ozogamicin), when
evaluated in a murine toxicity model assessing the risk of neutropenia (low
numbers of infection-fighting white blood cells).

The four-week study aimed to assess the efficacy of two development leads, a
lead and a back-up, of BVX001 (BVX001-1 and BVX001-2) alongside an untreated
negative control group (vehicle only) and very high doses of Cytarabine, or
"Ara C", a clinically approved AML chemotherapy drug that can only be given at
this dose to medically "fit" patients with AML for very short periods. Three
dosing regimens were evaluated for each development lead: 10mg/kg dosed twice
weekly, 10mg/kg dosed once weekly, and 3mg/kg dosed twice weekly for 28 days.

All BVX001 dosing regimens resulted in a highly statistically significant
(p-value <0.001) tumour growth inhibition of >87% at day 28, when
compared to the untreated negative control group. At a dosing of 10mg/kg twice
weekly, both development leads yielded a highly statistically significant
(p-value <0.001) tumour regression at day 28 of 93% and 89%, respectively.
All doses were well-tolerated. The highly statistically significant
regressions in tumour volume reported with each development lead dosed at
10mg/kg twice weekly are shown in the graph below.

 

 

 

 

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc,
commented: "This strong in vivo efficacy data we are seeing from our first
clinical candidate provides clear validation for our first-in-class Bi-Cygni®
therapeutics and their potential to provide much-needed further treatment
options for patients with Acute Myeloid Leukaemia, one of the most aggressive
forms of cancer. By identifying novel cancer-specific "Bi-Cygni®
fingerprints", such as the one used for BVX001, we are seeing superior cancer
cell selectivity, improving the overall effectiveness of the therapy by
potentially significantly reducing toxicities and thereby offering the
potential to give larger doses of treatment to patients for longer durations,
to result in better outcomes. We will continue to progress BVX001 through
further preclinical studies towards obtaining regulatory approval to initiate
human trials, while seeking suitable third-party partnerships to support
manufacturing and clinical development activities as well as commercialisation
of the asset."

This announcement follows the identification of a development lead for
BiVictriX's BVX001 programme in December 2022
(https://bivictrix.com/news/bivictrix-identifies-development-lead-for-bvx001-programme/)
, which was taken forward into several in vivo studies. A highly favourable
bone marrow safety profile for BVX001 versus Mylotarg® was announced in
January 2023
(https://bivictrix.com/news/bivictrix-announces-positive-data-from-preclinical-study-of-bvx001/)
.

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 leukaemic cells amongst
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.

 

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  MSCFAMRTMTAMBPJ