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)

CAR-T Digest - August 2020

Weekly Digest - January 2026

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)

Avacta Therapeutics announced that the U.S. FDA has cleared the Investigational New Drug application for FAP-Exatecan (AVA6103), the company’s second pre|CISION oncology program, enabling the transition of this tumor-activated therapy from preclinical development into first-in-human testing
The clearance allows Avacta to initiate a Phase 1 clinical trial later in Q1 2026, designed to evaluate safety, early efficacy signals, and dose selection for further development in patients with pancreatic, cervical, gastric, and small cell lung cancers
Tumor selection for the study was informed by an AI-driven approach developed in collaboration with Tempus AI, integrating sensitivity markers for topoisomerase I inhibitors with fibroblast activation protein expression to guide a more precise clinical strategy
The Phase 1 trial will enroll adult patients in a dose-escalation design with two parallel dosing schedules, every two weeks and every three weeks, with preliminary clinical data expected in the second half of 2026
With FAP-Exd advancing to the clinic in just 24 months, Avacta highlighted the IND clearance as a key milestone for the pre|CISION platform, supporting its potential to improve tumor-targeted delivery of potent payloads while limiting systemic toxicity and validating the platform’s broader applicability across oncology programs