REG - Avacta Group PLC - Successful Completion of Fourth Dose Escalation

AvactaAnnouncement

17/01/2023 07:00

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RNS Number : 9050M  Avacta Group PLC  17 January 2023

 

17 January 2023

 

Avacta Group plc

 

("Avacta" or "the Group" or "the Company")

 

Avacta Announces Successful Completion of Fourth Dose Escalation in AVA6000
Phase 1 Clinical Study

 

Positive safety profile of AVA6000 continues in the fourth cohort

 

Analysis of six tumour biopsies confirms the tumour targeting potential of
pre|CISION(TM) technology

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative,
targeted oncology drugs and powerful diagnostics announces that AVA6000
continues to show a very favourable safety profile in the fourth dose cohort
of the ALS-6000-101 dose escalation phase 1 clinical trial. Additionally,
analysis of tumour biopsies obtained from six patients across several cohorts
indicates that doxorubicin is being released within the tumour tissue
confirming the tumour targeting potential of the pre|CISION(TM) technology.

 

AVA6000 continues to be well tolerated by patients in cohort 4 with a marked
reduction in the incidence and severity of the typical toxicities associated
with the standard doxorubicin chemotherapy administration. Typical toxicities
include alopecia, myelosuppression, nausea, vomiting, mucositis and
cardiotoxicity. Importantly, even at the highest dosing levels in cohort 4,
equivalent to more than double the normal dose of doxorubicin, the typical
drug-related cardiotoxicity of doxorubicin was not observed.

 

A number of tumour biopsies obtained from patients in different cohorts have
also been analysed in order to confirm the release of the active chemotherapy,
doxorubicin, in the tumour tissue. This analysis shows that AVA6000 targets
the release of doxorubicin to the tumour tissue at therapeutic levels which
are much higher than the levels being detected in the bloodstream at the same
timepoint.

 

19 patients with a range of advanced and/or metastatic solid tumours enrolled
across four cohorts, have been administered AVA6000 to date. On the basis of
the very favourable safety profile of AVA6000 in the study to date, the Safety
Data Monitoring Committee (SDMC) has recommended continuation to higher dose
cohorts with the aim of identifying a maximum tolerated dose (MTD) necessary
to inform the dosing levels for the phase 1b and future studies. The Company
expects that it will complete these additional cohorts during the first half
of 2023.

 

Dr Alastair Smith, Chief Executive Officer of Avacta Group plc commented:

"We're delighted with the very positive data emerging from the dose escalation
study of our lead pre|CISION(TM) tumour targeted therapy AVA6000. The very
significant reduction in the usual toxicities, plus the observed release of
doxorubicin at significant levels in the tumour tissue, show that the
pre|CISION(TM) platform has the potential to significantly improve the safety
and tolerability of chemotherapies, and other drugs, by targeting their
release to the tumour.

 

"This is extremely encouraging as we work towards realising our vision of
"chemotherapy without side effects" to make a meaningful difference to cancer
patients' lives.

 

"We are now in a position to proceed beyond the fourth cohort in the dose
escalation study to even higher doses than originally anticipated, which is an
unexpected and very positive development. The data being generated in the
ALS-6000-101 study are providing detailed insights into the pre|CISION(TM)
platform which add significant value to the technology and confirm the
potential of the pre|CISION(TM) platform."

 

 

-Ends-

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this
announcement via a Regulatory Information Service ('RIS'), this inside
information is now considered to be in the public domain.

 

For further information from Avacta Group plc, please contact:

 

 Avacta Group plc                                                                Tel: +44 (0) 1904 21 7070

 Alastair Smith, Chief Executive Officer                                         www.avacta.com (http://www.avacta.com)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director

 Stifel Nicolaus Europe Limited (Nomad and Broker)                               Tel: +44 (0) 207 710 7600

 Nicholas Moore / Nick Adams / Samira Essebiyea / Nick Harland / Dhiren Suares   www.stifel.com (http://www.stifel.com/)
 / William Palmer-Brown

 FTI Consulting (Financial Media and IR)                                         Tel: +44(0) 203 727 1000

 Simon Conway / Alex Shaw / George Kendrick                                      Avacta.LS@fticonsulting.com (mailto:Avacta.LS@fticonsulting.com)

 Zyme Communications (Trade and Regional Media)                                  Tel: +44 (0)7891 477 378

 Lily Jeffery                                                                    lily.jeffery@zymecommunications.com

                                                                               (mailto:katie.odgaard@zymecommunications.com)

 

About Avacta Group plc - https://www.avacta.com (https://www.avacta.com/)

 

Avacta Group plc is a life sciences company working to improve people's health
and well-being through innovative oncology drugs and powerful diagnostics.
Operating through two divisions, Diagnostics and Therapeutics, the Group's
mission is to provide professionals and consumers with solutions that improve
healthcare, fitness and well-being.

 

Avacta's Therapeutics Division, a clinical stage oncology drug innovator, is
building a wholly owned pipeline of novel Affimer(®) immunotherapies and
pre||CISION™ tumour targeted chemotherapies. This approach is designed to
address the lack of a durable response to current cancer immunotherapies
experienced by most patients and reduce the severe systemic toxicities caused
by chemotherapies. There are five programmes in the pipeline as well as
several global research collaborations and licensing partnerships. Avacta's
lead programme, AVA6000, is a preCISION™ tumour-targeted form of the
established chemotherapy doxorubicin. AVA6000 is in Phase I clinical trials in
patients with locally advanced or metastatic selected solid tumours.

 

The Affimer(®) platform is an alternative to antibodies that has been
designed to address many of the drawbacks of antibodies which, despite their
shortcomings, currently dominate the immuno-diagnostics and
immuno-therapeutics markets.

 

The pre|CISION™ tumour targeting platform can be used to modify a
chemotherapy in order to selectively release the active drug in tumour tissue
thereby reducing the systemic exposure that causes damage to healthy tissues.
pre|CISION™ modified chemotherapies are designed to reduce the side effects
and improve the overall safety and therapeutic potential of these powerful
anti-cancer treatments.

 

Avacta's Diagnostics Division develops and supplies a broad range of in-vitro
diagnostic (IVD) solutions. The Division is growing rapidly through an M&A
strategy to deliver a global scale IVD business providing market leading
solutions for healthcare professionals and consumers to inform treatment and
monitor health and well-being. In October 2022, Avacta acquired Launch
Diagnostics which serves the hospital pathology laboratory market in the UK
and Europe. Avacta Diagnostic's research and development centre in Wetherby,
UK uses its proprietary Affimer(®) platform to differentiate immunodiagnostic
products to provide marketing leading performance.

 

To register for news alerts by email go to
www.avacta.com/investor-news-email-alerts
(http://www.avacta.com/investor-news-email-alerts)

 

 

 

About AVA6000

 

AVA6000 is a novel form of doxorubicin that has been modified with Avacta's
pre|CISION™ FAP-activated delivery platform to improve its safety and
therapeutic index. AVA6000 has been designed to limit cell penetration of the
drug- and therefore its cell killing effect- until it is specifically
activated by fibroblast activation protein α (FAP) which is in high
concentration in many solid tumours compared with healthy tissues. The
resulting reduced exposure of healthy tissues to free doxorubicin has the
potential to significantly increase its therapeutic index by reducing the
incidence of adverse effects, including cardiotoxicity and myelosuppression.

 

Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a
market size that is expected to grow to $1.38bn by 2024 1 , are widely used as
part of standard of care in several tumour types, but its use is limited by
cumulative dose toxicity associated with cardiomyopathy.

 

 1 
 https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html
(https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html)

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