REG - Avacta Group PLC - First Patient Dosed in Fifth Cohort of AVA6000

AvactaAnnouncement

05/04/2023 07:15

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RNS Number : 3893V  Avacta Group PLC  05 April 2023

 

 

 

5 April 2023

 

Avacta Group plc

 

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

 

First Patient Dosed in Fifth Cohort of AVA6000 Phase Ia Dose Escalation Study

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative,
targeted oncology drugs and powerful diagnostics, announces that the first
patient has been dosed in the fifth cohort of the first-in-human phase I trial
(ALS-6000-101) of AVA6000. This follows the approval of an amended clinical
trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA)
to allow for higher levels of dosing.

 

Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians
currently recruiting patients, has recommended that the phase Ia dose
escalation clinical trial continues to a fifth dose cohort at 250mg/m(2),
following the favourable safety profile of AVA6000 generated in the study to
date. Escalation to this level of dosing falls outside of the original
clinical trial protocol, and therefore the protocol required amendment and
approval by the MHRA, which has now been completed. 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 Officer of Avacta Group, commented:

 

"We are very much encouraged by the positive safety and tolerability data
emerging from the dose escalation phase 1a study of AVA6000. Following the
recommendation from the SDMC, and approval by the MHRA, we are pleased to
commence dosing in the fifth patient cohort of this trial.

 

The recent confirmation of release of active chemotherapy in the tumour tissue
and the safety data being generated in the ALS-6000-101 study are providing
detailed insights into the pre|CISION™ platform which add significant value
to the technology and confirm the tumour targeting potential of the
pre|CISION™ platform."

 

This announcement has been approved for release by Alastair Smith, Chief
Executive Officer of Avacta Group plc.

 

 

-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 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 (FAPα) which is in high
concentration in many solid tumours compared with healthy tissues. The
resulting reduced exposure of healthy tissues to active 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)

 

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. 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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