REG - Avacta Group PLC - Completion of Fifth Dose Escalation in AVA6000

AvactaAnnouncement

21/06/2023 07:00

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RNS Number : 3595D  Avacta Group PLC  21 June 2023

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

 

 

21 June 2023

 

Avacta Group plc

 

("Avacta" or the "Company" and, together with its subsidiary undertakings, the
"Group")

 

 

Successful Completion of Fifth Dose Escalation in AVA6000 Phase 1 Clinical
Study

 

Very positive safety profile of AVA6000 continues to be observed in the fifth
cohort

 

Several patients remain on trial in different dose cohorts and continue to
receive AVA6000 as their disease has not progressed

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative,
targeted oncology drugs and powerful diagnostics, today announces that the
fifth dose escalation cohort in the ALS-6000-101 dose escalation Phase 1
clinical trial to evaluate the safety and tolerability of AVA6000 has been
completed successfully. The data continue to show a very favourable safety
profile for the tumour targeted chemotherapy and several patients in cohort 5
and earlier cohorts remain on treatment as their disease has not progressed.

 

AVA6000 is a form of doxorubicin that has been chemically modified with
Avacta's pre|CISION(TM) platform designed to reduce systemic side effects by
targeting the release of active chemotherapy in tumour tissue. Despite the
high dose level in the fifth cohort which is approximately 2.25 times a
typical dose of doxorubicin, AVA6000 has continued to be well tolerated by
patients with a marked reduction in the incidence and severity of the typical
toxicities associated with the standard doxorubicin chemotherapy
administration.

 

The emerging positive safety and pharmacokinetic data from the study support
the potential clinical differentiation of AVA6000 over doxorubicin. This
includes: (i) higher dosing of AVA6000 compared to standard doxorubicin, (ii)
more frequent dosing of AVA6000 compared to doxorubicin - doxorubicin is
typically dosed every three weeks in order for patients to recover from the
side effects of treatment, (iii) the ability to administer many more cycles of
AVA6000 compared to doxorubicin.

 

A total of 29 patients with a range of advanced and/or metastatic solid
tumours have now been dosed at the clinical trial in sites in the UK and
United States. 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 the sixth dose cohort at 310 mg/m(2), which is
equivalent to 2.7 times the standard dose of doxorubicin. This continued dose
escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to
inform the dosing levels for the Phase 1b and future studies.

 

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

 

"The continued positive safety profile of AVA6000 at these dose levels
compared with standard doxorubicin is remarkable. We are seeing a significant
reduction in the incidence and severity of all doxorubicin side effects.
Analysis of the tumour biopsies to date also confirms that enough doxorubicin
is being released in the tumour to have a therapeutic effect. If even higher
doses of AVA6000 are tolerated then this may make a significant difference to
the outcomes for patients in the upcoming efficacy study.

 

"We are keen to progress onto the Phase 1b efficacy study as soon as possible
following completion of the dose finding Phase 1a study. The dose expansion
Phase 1b study will provide an initial evaluation of efficacy and of the
relative improvement in patient outcomes and quality of life of different
dosing regimens of AVA6000 compared with the standard doxorubicin regimen."

 

 

-Ends-

 

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                                                        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 - www.avacta.com (http://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 pre|CISION™ 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. In May 2023, Avacta acquired Coris Bioconcept a Belgium based
lateral flow test developer and manufacturer adding a broad range of marketed
professional-use rapid tests into the Diagnostics Division. 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)

 

 

 

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