REG - Avacta Group PLC - Phase 1 study opening for AVA6103

AvactaAnnouncement

Today 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260316:nRSP6745Wa&default-theme=true

RNS Number : 6745W  Avacta Group PLC  16 March 2026

 

 

Avacta announces opening of Phase 1 trial for second pipeline asset, FAP-Exd
(AVA6103) a sustained-release pre|CISION(®) exatecan peptide-drug conjugate

 

Specialty U.S. oncology centers open for recruitment in Virginia and Texas

 

 

LONDON and PHILADELPHIA - March 16, 2026 - Avacta Therapeutics (AIM: AVCT,
"the Company", "Avacta"), a clinical stage biopharmaceutical company
developing pre|CISION(®), a tumor-activated oncology delivery platform,
today announced the opening of the Phase 1 trial of FAP-Exd (AVA6103), the
Company's second clinical program and the first sustained-release
pre|CISION(®) peptide drug conjugate.  FAP-Exd (AVA6103) is a fibroblast
activation protein (FAP)-released version of exatecan, a highly potent
topoisomerase I inhibitor.

 

The Phase 1a dose escalation portion of the clinical trial will evaluate the
safety, tumor and plasma pharmacokinetics and preliminary efficacy of AVA6103
in patients diagnosed with one of four solid tumors in the advanced setting:
pancreatic cancer, cervical and vulvar cancer, gastric and gastroesophageal
junction cancers and small cell lung cancer.  The trial is designed to
identify a dose and regimen for further clinical development.

 

The first patient is anticipated to enroll in the study before the end of
March.  Adult participants will be enrolled in the Phase 1a dose-escalation
portion of the trial with parallel arms investigating two schedules of
administration (every two weeks; Q2W, and every three weeks; Q3W), with
preliminary safety and pharmacokinetic data anticipated in the second half of
2026.

 

The first two centers to open for enrollment are the Virginia Cancer
Specialists (VCS) Research Institute in Fairfax, Virgina, and NEXT Oncology
Specialists in Dallas, Texas.

 

Christina Coughlin, CEO of Avacta Therapeutics, commented:

 

"The opening of the first clinical sites in the Phase 1 trial of AVA6103 is an
important milestone. It is notable that this program continues to move into
clinical development faster than normal industry timelines. With our
proprietary sustained release mechanism, we expect AVA6103 to enable greater
efficacy from the exatecan payload while limiting the severe toxicities that
were observed in the initial development of this payload in the clinic."

 

 

-Ends-

 

 

 

For further information from Avacta, please contact:

 

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

 Christina Coughlin, Chief Executive Officer        via Cohesion Bureau

 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

 Cohesion Bureau                                    avacta@cohesionbureau.com (mailto:avacta@cohesionbureau.com)

 Communications / Media / Investors

 Richard Jarvis

 

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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESEAADLFESKEFA



            Copyright 2019 Regulatory News Service, all rights reserved