RCS - Avacta Group PLC - Avacta reports new AVA6103 pharmacology data

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RNS Number : 0258M  Avacta Group PLC  18 December 2025

 

Avacta reports new pharmacology data for FAP-Exd (AVA6103)

 

Multiple patient-derived xenograft models with prolonged complete responses
associated with sustained release of the exatecan payload within the tumor
over five days

 

LONDON and PHILADELPHIA - December 18, 2025 - Avacta Therapeutics (AIM: AVCT),
a clinical stage biopharmaceutical company developing pre|CISION(®), a
tumor-activated oncology delivery platform, today announced new pharmacology
data with its second asset, FAP-Exd (AVA6103) which is anticipated to begin
Phase 1 testing in Q1 2026.

 

FAP-Exd (AVA6103) is a pre|CISION(®) peptide drug conjugate comprised of the
proprietary FAP-cleavable peptide linked to a highly potent topoisomerase I
(topo I) inhibitor, a key antitumor mechanism useful in many human solid tumor
types.

 

Today's new data include the following observations:

 

·    Potent tumor-specific and broad-spectrum cytotoxicity: FAP-Exd
(pre|CISION exatecan) is a potent peptide drug conjugate designed to produce
sustained release of active exatecan directly in the tumor via the pre|CISION
bystander effect

 

·    Sustained release mechanism in the tumor is highly effective: The
sustained release mechanism produces a maximum concentration (Cmax) of
released exatecan, with exposure duration of over five days in the tumor, with
plasma exposure gone in two hours

 

·    High levels of antitumor activity of FAP-Exd: Multiple
patient-derived xenograft models demonstrate robust antitumor activity with
deeper and more durable responses than achieved with conventional exatecan

 

·    FAP-Exd has the potential to reach a broad patient population with
high unmet need: Exatecan is the most potent topoisomerase I inhibitor that
has been tested in the clinic and as a pre|CISION medicine delivers exatecan
directly to the tumor with the potential to address multiple indications with
high unmet need

 

·    Faster and more robust Phase 1 development using AI: The clinical
development of FAP-Exd was designed using an AI approach, querying a large
database to identify those cancer indications with the highest likelihood of
response to the drug through co-expression of FAP and SLFN11

 

 

 

Christina Coughlin MD, PhD, CEO of Avacta, commented:

 

"These data are key to support the clinical development of FAP-Exd (AVA6103)
and the profile of this second pre|CISION medicine in the preclinical setting
is tremendous.  The sustained release mechanism developed by Avacta
scientists results in a robust concentration of active drug in the tumor over
five days with the disappearance from the bloodstream in only two hours. This
is the exact profile needed to achieve better efficacy with this highly potent
topo I inhibitor.

 

"Our AI collaboration has led to several key insights into the patient
population for the FAP-Exd program and has helped to drive a smarter and
faster clinical trial.  We are eagerly anticipating the next steps for this
exciting program in 2026."

 

 

 

 

-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

 Zeus (Joint 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)

                                                           mailto:Carly@carlyscadutoconsulting.com
 Carly Scaduto

 THRUST Strategic Communications

 

 

About Avacta - www.avacta.com
(https://eur01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.avacta.com%2F&data=05%7C02%7CChris.Coughlin%40avacta.com%7Ce5faa8dfbe3d49fc56f808dd35799958%7C64d2165ff9e04869bc73bfe4fc4fa9ab%7C0%7C0%7C638725518576703790%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=qWTC74zmTzjVQqwaFiKeiHUwMY5RUlsvb7C%2BkLRahGU%3D&reserved=0)

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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