Avacta Therapeutics (AVCT), a clinical-stage biopharmaceutical company, Wednesday announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug or IND application for the company's second program, FAP-Exd, marking an important milestone in the development of AVA6103, which is the first pre|CISION peptide drug conjugate based on the highly potent topoisomerase I inhibitor, exatecan.
The IND approval allows Avacta to move the FAP-Exd program from the lab into human testing. The upcoming Phase 1 clinical trial will evaluate the safety and potential efficacy of FAP-Exd and seek to identify a suitable dose for further clinical development in patients with four solid tumor types- pancreatic cancer, cervical cancer, gastric cancer, and small cell lung cancer.
The Phase 1 trial will enroll adult participants in the dose-escalation part, with two parallel arms investigating two schedules of administration: every two weeks (Q2W) and every three weeks (Q3W).
The company expects preliminary data from this trial in the second half of 2026.
Currently, Avacta's stock is moving up 5.66 percent, to 56.00 pence on the London Stock Exchange.
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