Avacta Group Regulatory News (AVCT)

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."

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About Avacta - 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.