**Summary**
Avacta Group PLC announced on January 21, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FAP-Exatecan (AVA6103), the companys second pre
CISION® medicine. This clearance marks a significant milestone, allowing the program to advance from preclinical development into human <mark style="background-color:yellow">test</mark>ing. The Phase 1 clinical trial, expected to begin in Q1 2026, will evaluate the safety, efficacy, and optimal dosing of AVA6103 in patients with four solid tumor types: pancreatic, cervical, gastric, and small cell lung cancers. These tumor types were selected based on AI-driven analysis of sensitivity markers and FAP expression in collaboration with Tempus AI.
AVA6103 is a peptide drug conjugate that leverages Avactas proprietary pre
CISION® platform, designed to deliver potent cancer therapies directly to tumors while minimizing toxicity to healthy tissues. The trial will include a dose-escalation phase with two parallel arms testing different administration schedules, and preliminary data is anticipated in the second half of 2026. Avactas leadership highlighted the rapid progression of the program (24 months from inception to IND clearance) and the potential of the pre
CISION® platform to revolutionize cancer treatment by enhancing efficacy and reducing side effects. Clinical experts, including Dr. Alexander Spira, expressed enthusiasm for the trials potential to advance targeted cancer therapy.