Avacta Group plc (LSE:AVCT) has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application covering FAP-Exatecan (AVA6103), marking a key milestone for the company’s pre|CISION® platform. AVA6103 is Avacta’s second pre|CISION® medicine and its first peptide drug conjugate incorporating the potent topoisomerase I inhibitor exatecan.
The IND approval enables Avacta to move AVA6103 from preclinical development into a Phase 1 clinical trial in the United States, which is expected to begin later in the first quarter of 2026. The study will evaluate safety, tolerability, dosing and early signs of efficacy in adult patients with pancreatic, cervical, gastric and small cell lung cancers, using two different dosing regimens. Initial clinical data are anticipated in the second half of 2026.
Management highlighted the rapid progression of the programme, advancing from inception to IND clearance in around 24 months, as a strong validation of the pre|CISION® platform. The technology is designed to deliver a sustained-release of highly potent drugs within the tumour microenvironment, with the aim of improving anti-cancer activity while reducing the systemic toxicities typically associated with exatecan.
Strategically, Avacta believes AVA6103 could strengthen its position in next-generation oncology therapeutics and provide valuable clinical proof-of-concept for the broader application of its capping group and linker technologies across multiple drug payloads. However, the overall outlook continues to be shaped by financial constraints, limited partnering activity and weak technical indicators, with negative earnings and no dividend weighing on valuation.
More about Avacta Group plc
Avacta Group plc is a clinical-stage life sciences and biopharmaceutical group focused on oncology through its therapeutics division, Avacta Therapeutics. The company is developing its proprietary pre|CISION® tumour-activated drug delivery platform, which uses fibroblast activation protein (FAP) to selectively release potent payloads, including peptide and Affimer® drug conjugates, within the tumour microenvironment, with the aim of enhancing efficacy while reducing systemic toxicity compared with conventional approaches.
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