REG - Avacta Group PLC - 1st US Clinical Investigator AVA6000 Sites Opened

AvactaAnnouncement

06/04/2023 07:00

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RNS Number : 5579V  Avacta Group PLC  06 April 2023

 

 

6 April 2023

 

Avacta Group plc

 

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

 

Avacta Opens First Two US Clinical Investigator Sites for AVA6000 Phase 1
Clinical Study

 

Memorial Sloan Kettering Cancer Center and Fred Hutch Cancer Center now open
for patient enrolment to pre|CISION™ lead programme, AVA6000

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative,
targeted oncology drugs and powerful diagnostics, announces the opening on 5
April 2023 of the first two clinical investigator sites for the phase 1
clinical trial of AVA6000 under its US Investigational New Drug (IND)
Application. The two sites, Memorial Sloan Kettering Cancer Center (MSK) in
New York and Fred Hutch Cancer Center in Seattle, are now open for patient
enrolment to ALS-6000-101. This is the first-in-human trial of AVA6000,
Avacta's lead pre|CISION™ drug candidate for the treatment of soft tissue
sarcoma.

 

Active enrolment has now begun for soft tissue sarcoma patients to the phase 1
clinical trial in the US, led by Dr William D. Tap, Chief of the Sarcoma
Medical Oncology Service at MSK, and Dr Lee D. Cranmer, Professor at the
Clinical Research Division of Fred Hutch Cancer Center.

 

The opening of the US phase 1 trial sites for recruitment marks a significant
milestone in Avacta's plan to expand AVA6000 clinical studies. A phase 1a dose
escalation study is currently underway in the UK and recently begun dosing
patients in the fifth cohort at 250 mg/m(2) as announced on 5 April 2023,
following the favourable safety profile of AVA6000 generated in the study to
date. The US trial sites will initially contribute patients to the dose
escalation phase, while being uniquely positioned to lead the enrolment of
soft tissue sarcoma patients in the phase 1b dose expansion stage of the
AVA6000 study when this begins. Patients will receive the same doses at each
stage of the trial as in the UK.

 

The Company will provide further updates in respect of the progress of the US
phase 1 trial as appropriate.

Neil Bell, Chief Development Officer for Avacta Therapeutics, commented:

 

"This timely opening of these two key US sites, under the expert direction of
Dr Tap and Professor Cranmer, is a major milestone in Avacta's entry strategy
into the US with our promising AVA6000 pre|CISION™ lead programme. We share
with our US colleagues a clear vision to transform treatment outcomes for
patients, and we look forward to working together as we continue to build the
clinical evidence base for the safety and tolerability of AVA6000, in addition
to the significant 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-

 

 

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
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(http://www.avacta.com/investor-news-email-alerts)

 

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