REG - BiVictriX Therapcts. - Extended Survival Rates Reported with BVX001

Bivictrix TherapeuticsAnnouncement

12/10/2023 07:00

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RNS Number : 8536P  BiVictriX Therapeutics PLC  12 October 2023

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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

 

 

Extended survival rates reported with BVX001 in a pre-clinical model of

Acute Myeloid Leukaemia

 

·    BVX001 increased survival rates in a difficult-to-treat pre-clinical
model of Acute Myeloid Leukaemia by 126% as compared to untreated control.

·    These pre-clinical survival data build upon the recently announced
positive efficacy data with BVX001 that showed statistically significant
tumour regressions of up to 97%.

·    Taken together, these data significantly strengthen the preclinical
data package for BVX001, supporting IND-enabling studies and accelerated
progress towards the clinic.

 

Alderley Park, 12 October 2023 - BiVictriX Therapeutics plc (AIM: BVX), an
emerging biotechnology company applying a differentiated approach to develop
novel, next-generation precision bispecific Antibody Drug Conjugates, offering
substantially improved cancer cell selectivity and therapeutic activity,
announces today that, BVX001, a first-in-class Bi-Cygni® antibody drug
conjugate ("ADC") for the treatment of Acute Myeloid Leukaemia ("AML"),
significantly prolonged survival rates in an established preclinical model of
AML.

 

These survival results build on the positive pre-clinical murine efficacy data
announced in June 2023
(https://bivictrix.com/news/bivictrix-nominates-clinical-candidate-for-bvx001/)
. The study assessed BVX001 as compared to HiDAC (the highest accepted dose of
the clinically approved AML chemotherapy drug Cytarabine ("Ara C"), only given
to the fittest patients for short periods due to extremely high toxicity);
together with an untreated control group (vehicle only).

 

Following the 28-day dosing period and efficacy assessment, the duration of
survival post treatment was determined. Encouragingly, the median survival
rate observed in the BVX001 treatment group (10mg/kg dosed twice weekly) was
129 days versus 91 days as reported for the HiDAC treatment group, both
calculated from treatment initiation, as compared to 57 days for the untreated
control. This constitutes a median survival advantage for BVX001 of
126% versus untreated control and a median survival advantage of 42% versus
HiDAC.

 

This preclinical model represents a more challenging model of AML than is
found in the clinic, with more cells able to drive cancer progression than the
limited number of specialised driver cells (Leukaemia Initiating Cells
("LICs") or Leukaemia Stem Cells ("LSCs")) that are found in AML patients.

 

BVX001 extends median survival by 126%

 

Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc, said:
"Acute Myeloid Leukaemia remains a significant unmet medical need, linked to
one of the poorest overall survival rates across all cancers. All 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 recent
pre-clinical data, demonstrating that BVX001 provides clear survival benefits,
even in this challenging AML model. This data adds further strength to our
existing and comprehensive pre-clinical data package, as we accelerate work
towards obtaining regulatory approval to support the progression of BVX001
into human trials."

 

Jane Kendrew, Director of Translational Oncology at Sygnature Discovery
(contract research organisation that conducted the study), added: "We have
built a strong relationship with BiVictriX and have had the pleasure of
conducting all of their in vivo efficacy models to date for BVX001. From our
experience as a highly reputable CRO for pre-clinical studies in the oncology
space, and from my own experience as a leader in translational oncology for
over 20 years, the efficacy data generated with BVX001 is amongst the best we
have reported in the AML setting. We look forward to continuing to work
closely with BiVictriX as they progress this highly promising asset into the
clinic."

 

 

 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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