Avacta Therapeutics announced 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.
