REG - Avacta Group PLC - FDA Clearance of IND Application for AVA6103

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RNS Number : 6789P  Avacta Group PLC  21 January 2026

 

Avacta Announces U.S. Food and Drug Administration Clearance of the
Investigational New Drug (IND) Application for the Second pre|CISION(®)
Medicine, FAP-Exatecan (AVA6103)

 

The Phase 1 clinical study of FAP-Exd (AVA6103) is anticipated to begin later
in Q1 2026

 

 

LONDON and PHILADELPHIA - January 21, 2026 - Avacta Therapeutics (AIM: AVCT,
"the Company", "Avacta"), a clinical stage biopharmaceutical company
developing pre|CISION(®), a tumor-activated oncology delivery platform, is
pleased to announce U.S. Food and Drug Administration (FDA) clearance of the
Investigational New Drug (IND) application for the Company's second program
FAP-Exd (AVA6103), the first pre|CISION(®) peptide drug conjugate based on
the highly potent topoisomerase I inhibitor, exatecan.

 

The IND approval is an important step in the development of AVA6103 as this is
the point where the program moves from the lab into human testing. The Phase 1
clinical trial will evaluate the safety and potential efficacy of FAP-Exd and
seek to identify a dose for further clinical development in patients with four
solid tumors, pancreatic cancer, cervical cancer, gastric cancer and small
cell lung cancer. The selection of these tumor types was based on an AI
approach investigating a sensitivity marker for topoisomerase I inhibitors and
FAP expression as part of the strategic collaboration with Tempus AI.

 

Adult participants will be enrolled in the dose-escalation part of the trial
with two parallel arms investigating two schedules of administration (every
two weeks, Q2W and every three weeks, Q3W) with preliminary data from this
trial anticipated in the second half of 2026.

 

 

Christina Coughlin, MD, PhD, Chief Executive Officer at Avacta Therapeutics
commented,

 

"Taking FAP-Exd into the clinic is a critical milestone for the pre|CISION(®)
platform and for the Company. In moving the FAP-Exd program forward from
inception to a cleared IND in just 24 months, our team has exceeded industry
standard timelines. The sustained release mechanism of FAP-Exd, invented by
Avacta, is expected to enable greater efficacy in the clinic while limiting
the toxicities that were observed with exatecan in its original clinical
development. We are very excited to move this program forward for patients and
shareholders alike."

 

David Liebowitz, MD, PhD, Chief Medical Officer at Avacta Therapeutics
added,

 

"Our FAP-Exd program in the clinic will very soon provide a greater
understanding of the new chemistry of the pre|CISION(®) platform and also
validate the potential to move forward with varied payloads based on our novel
capping group and linker technologies. This new program will support a greater
understanding of our technology's broad applicability and validate our ability
to design molecules that maximize the exposure of our payloads in the tumor in
patients."

 

Alexander Spira MD, PhD, FACP, FASCO, Co-Director, Virginia Cancer Specialists
(VCS) Research Institute; Director, VCS Thoracic and Phase 1 Program; Chief
Scientific Officer, NEXT Oncology; and Clinical Assistant Professor, Johns
Hopkins also commented:

 

"I am thrilled to work with Avacta on this exciting new drug. The ability to
concentrate a potent topoisomerase I inhibitor directly in the tumor while
protecting normal tissues from harmful effects is the next stage of how we
should be treating cancer. We are looking forward to participating in this
second pre|CISION(®) Phase 1 trial and helping the Company to drive this
pioneering technology forward."

 

-Ends-

 

For further information from Avacta, please contact:

 

 Avacta Group plc

 Christina Coughlin, Chief Executive Officer                https://avacta.com/ (https://avacta.com/)

                                                            via ICR Healthcare

 Strand Hanson Limited (Nominated Adviser)

 James Harris / Chris Raggett / James Dance                 www.strandhanson.co.uk (https://www.strandhanson.co.uk/)

 Zeus (Broker)

 James Hornigold / George Duxberry / Dominic King           www.zeuscapital.co.uk (http://www.zeuscapital.co.uk)

 ICR Healthcare

 Mary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert   avacta@icrhealthcare.com (mailto:avacta@icrhealthcare.com)

 Investor Contact

 Renee Leck                                                 renee@thrustsc.com (mailto:renee@thrustsc.com)

 THRUST Strategic Communications

 Media Contact

 Carly Scaduto                                              Carly@carlyscadutoconsulting.com

                                                          (https://www.globenewswire.com/Tracker?data=YG-jwixFWaHByFwlhEr4NbVmhGc9YbrV0ozbiHY-33jDG-KDtaZDvqBLS4-5RgIi5zejtwvrLPO1U6xSYlV9BnK-dIegbuZft6wwj-ugstEWYrPDSrd9NwgKYBdm1l9Ty6VSa1gsRJqxeLaMfUN-easXzPVocBafm0xbzTKFahId-T7w4WgPYGYfKdFh6MGXNNniX0b0LrpQwjqHYj_mTmjerN3nRW6pwlbWejQ6wZCns0oke-U-WA7CB-Z2CD1ObedcWrqwKYgQwTY1NxAOLXtmHTL3VJ7HZ4Z3K9ZhB_2_vgbo4aKKTppE6l1bjU2w)
 Carly Scaduto Consulting

 

 

 

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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