Avacta Launches Phase 1 Trial for Tumour-Targeted Sustained-Release Exatecan Therapy

Avacta Therapeutics (LSE:AVCT) has initiated a Phase 1 clinical trial for FAP-Exd (AVA6103), its second program to enter the clinic and the first sustained-release therapy developed using the company’s pre|CISION peptide-drug conjugate platform. The study has begun enrolling patients at specialist oncology centres in Virginia and Texas. The investigational treatment is designed as a fibroblast activation protein (FAP)-activated form of exatecan, a potent topoisomerase I inhibitor, with the goal of delivering the drug’s effects more precisely within solid tumours.

The Phase 1a dose-escalation study will evaluate safety, tumour and plasma pharmacokinetics, and early indications of therapeutic activity in adults with advanced cancers, including pancreatic, cervical and vulvar, gastric and gastroesophageal junction, and small cell lung cancer. Patients will receive the therapy on either biweekly or triweekly dosing schedules. Avacta’s chief executive noted that AVA6103 has progressed into clinical testing more quickly than is typical for comparable drug development timelines. The company believes the therapy could enhance the anti-tumour potential of exatecan while reducing the severe toxicity that previously restricted its clinical use, representing an important step forward in expanding Avacta’s oncology pipeline.

Despite the clinical progress, the company’s overall outlook remains constrained by weak financial performance and bearish technical indicators. While pipeline advancement provides some positive momentum, ongoing funding needs and the absence of major partnerships continue to present challenges. Valuation metrics are also limited by negative earnings and the lack of dividend yield.

More about Avacta Group plc

Avacta Therapeutics, part of Avacta Group plc, is a clinical-stage biopharmaceutical company developing targeted oncology therapies using its proprietary pre|CISION platform. The technology is designed to release highly potent cytotoxic drugs selectively within the tumour microenvironment, aiming to improve treatment effectiveness while minimising systemic side effects. The company’s pipeline includes pre|CISION peptide-drug conjugates and Affimer-based drug conjugates intended to deliver next-generation cancer therapies with improved precision.

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