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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)
Globenewswire· 2026-01-21 13:03
Core Insights - Avacta Therapeutics has received FDA clearance for the Investigational New Drug (IND) application for FAP-Exd (AVA6103), marking a significant step in the development of this oncology drug [1][2] - The Phase 1 clinical trial will assess the safety and efficacy of FAP-Exd in patients with pancreatic cancer, cervical cancer, gastric cancer, and small cell lung cancer, utilizing an AI approach to select these tumor types [2][3] - The trial will include adult participants in a dose-escalation study with two administration schedules, with preliminary data expected in the second half of 2026 [3] Company Developments - The transition of FAP-Exd from lab to human testing within 24 months demonstrates the company's efficiency in advancing its programs [3] - The innovative sustained release mechanism of FAP-Exd aims to enhance efficacy while minimizing toxicities associated with exatecan [3] - The clinical program is expected to provide insights into the pre|CISION platform's chemistry and validate the potential for varied payloads based on novel technologies [3] Technology Overview - The pre|CISION platform is designed to deliver potent cancer therapies by concentrating them in the tumor microenvironment while sparing normal tissues [5][7] - The platform utilizes a proprietary peptide that targets fibroblast activation protein (FAP), which is upregulated in most solid tumors, allowing for optimized dosing and reduced systemic toxicity [6][7]