REG - Avacta Group PLC - Faridoxorubicin Program Clinical Updates

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RNS Number : 4824R  Avacta Group PLC  03 February 2026

 

Avacta announces two key clinical updates to its faridoxorubicin program

 

Cardiac dosing limit removed and path forward to dose selection identified

 

 

LONDON and PHILADELPHIA - February 3, 2026 - Avacta Therapeutics (AIM: AVCT,
"the Company", "Avacta"), a clinical stage biopharmaceutical company
developing pre|CISION(®), a tumor-activated oncology delivery platform, has
published two key clinical updates to its faridoxorubicin (AVA6000) clinical
program.

 

Agreed updates to the trial protocol include the removal of the maximum dosing
limit and to allow flexibility in dosing levels. These two developments
underscore the growing confidence from investigators and regulators in the
tolerability profile of faridoxorubicin and should support a smooth transition
to future efficacy studies.

 

The historic maximum dosing limit which is based on the patient's exposure to
released (free) doxorubicin, has been removed in the clinical trial following
the collection of highly favorable safety data from the faridoxorubicin
program and observation of patients receiving the highest cumulative doses for
prolonged periods. Dosing in the Phase 1 clinical trial escalated to a dose of
nearly 4x the conventional dose of doxorubicin and the maximum cumulative
exposure of released doxorubicin was increased to 550 mg/m(2) during the trial
with no severe cardiac toxicity observed.

 

One of the key advantages of the pre|CISION(®) platform is that its unique
delivery mechanism allows patients to receive the drug for longer and at
higher doses due to improved tolerability, with the potential to extend the
progression free survival endpoint in trials.

 

The Company's second significant update relates to the determination of the
dose for the study in efficacy trials. The final cohorts of patients with the
selected indications in Phase 1b will be enrolled, enabling two dose levels to
be compared in order to determine the optimal biologic dose in future trials.

 

Updates to the clinical program will appear in the National Library of
Medicine's clinicaltrials.gov entry for Faridoxorubicin (AVA6000) under the
trial designation, ID Number NCT04969835.

 

Christina Coughlin, CEO of Avacta Therapeutics commented,

 

"These two critical steps in the development of our faridoxorubicin (AVA6000)
program and by extension the proprietary pre|CISION(®) platform demonstrate
growing recognition by regulators of the safety of this platform.

 

"Highly favorable cardiac safety data for faridoxorubicin enable patients to
be treated longer, as opposed to stopping the drug for a theoretical risk of
cardiac toxicity which is the usual practice with doxorubicin therapy. Despite
dosing to nearly 4x the standard dose of doxorubicin as well as to a higher
lifetime maximum exposure, we have not seen a single case of severe cardiac
toxicity.

 

Furthermore, identifying the path forward to the selection of the optimal
biologic dose will enable a smooth transition to efficacy studies with
faridoxorubicin program and allows the Company to implement these approaches
in the platform currently in Phase 1b, facilitating the development across
pre|CISION(®) medicines."

 

-Ends-

 

For further information from Avacta, please contact:

 

 Avacta Group plc                                           https://avacta.com/ (https://avacta.com/)

 Christina Coughlin, Chief Executive Officer                via ICR Healthcare

 Strand Hanson Limited (Nominated Adviser)                  www.strandhanson.co.uk (http://www.strandhanson.co.uk)

 James Harris / Chris Raggett / James Dance

 Zeus (Broker)                                              www.zeuscapital.co.uk (http://www.zeuscapital.co.uk)

 James Hornigold / George Duxberry / Dominic King

 ICR Healthcare                                             avacta@icrhealthcare.com (mailto:avacta@icrhealthcare.com)

 Mary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert

 Investor Contact                                           renee@thrustsc.com (mailto:renee@thrustsc.com)

 Renee Leck

 THRUST Strategic Communications

 Media Contact                                              carly@thrustsc.com (mailto:carly@thrustsc.com)

 Carly Scaduto

 THRUST Strategic Communications

 

 

 

About Avacta - https://avacta.com/ (https://avacta.com/)

Avacta Therapeutics is a clinical-stage life sciences company expanding the
reach of highly potent cancer therapies with the pre|CISION(®) platform.
pre|CISION(®) is a proprietary payload delivery system based on a
tumor-specific protease (fibroblast activation protein or FAP) that is
designed to concentrate highly potent payloads in the tumor microenvironment
while sparing normal tissues.

 

Our innovative pipeline consists of pre|CISION(®) peptide drug conjugates
(PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific
release mechanism, providing unique benefits over traditional antibody drug
conjugates.

 

The pre|CISION(®) platform comprises an anticancer payload conjugated to a
proprietary peptide that is a highly specific substrate for fibroblast
activation protein (FAP) which is upregulated in most solid tumors compared
with healthy tissues. The pre|CISION(®) platform harnesses this tumor
specific protease to cleave pre|CISION(®) peptide drug conjugates and
pre|CISION(®) antibody/Affimer(®) drug conjugates in the tumor
microenvironment, thus releasing active payload in the tumor and reducing
systemic exposure and toxicity, allowing dosing to be optimized to deliver the
best outcomes for patients.

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