Biopharmaceutical company Avacta Group PLC (AIM: AVCT) announced on Wednesday that it has received clearance from the U.S. Food and Drug Administration of the Investigational New Drug application for FAP-Exatecan (AVA6103), the company's second pre|CISION medicine and first peptide drug conjugate using the topoisomerase I inhibitor exatecan.

This clearance enables progression from preclinical development into human clinical testing.

Phase 1 clinical evaluation of FAP-Exd (AVA6103) is expected to begin later in Q1 2026. The study will assess safety, potential efficacy and dose selection for further development in patients with pancreatic, cervical, gastric and small cell lung cancers. Tumour selection was informed by an artificial intelligence approach analysing sensitivity markers for topoisomerase I inhibitors and fibroblast activation protein expression under a strategic collaboration with Tempus AI.

The trial will enrol adult patients in a dose-escalation design with two parallel dosing schedules, every two weeks and every three weeks. Preliminary data are anticipated in the second half of 2026.

Avacta Group PLC developing the pre|CISION platform, a tumour-activated delivery system designed to concentrate highly potent oncology payloads within the tumour microenvironment while limiting systemic exposure. The platform underpins a pipeline of peptide and Affimer drug conjugates intended to improve therapeutic outcomes versus conventional antibody drug conjugates.