Avacta (LSE:AVCT) has dosed the first patient in its Phase 1 FOCUS-01 clinical trial evaluating FAP-Exd (AVA6103), a Gen Two pre|CISION-based exatecan peptide drug conjugate designed to treat selected advanced solid tumours. The trial is being conducted at three specialist oncology centres in the United States.
The study follows a recent £10 million fundraising that extended the company’s cash runway into early 2027. FOCUS-01 is expected to enrol around 144 patients and will employ AI-assisted tumour selection together with a Bayesian dose-escalation framework. The trial aims to deliver initial safety, pharmacokinetic and early efficacy data later this year, marking an important milestone in the development of Avacta’s targeted oncology pipeline and further validation of its tumour-activated drug platform.
The trial will focus on cancers including pancreatic, cervical and vulvar, gastric and gastroesophageal junction, and small cell lung cancer. Patient selection is supported by gene-expression analysis from Tempus AI, which is being used to identify tumours where fibroblast activation protein (FAP) expression aligns with potential sensitivity to topoisomerase I inhibition.
The study will also test two different dosing schedules while evaluating a sustained-release mechanism designed to increase drug concentration within tumours while limiting exposure to healthy tissue. If successful, AVA6103 could expand the clinical and commercial potential of Avacta’s pre|CISION platform beyond its lead candidate AVA6000 and strengthen the company’s position in the emerging class of exatecan-based targeted therapies.
Despite the clinical progress, Avacta’s outlook remains constrained by financial pressures. The company continues to report losses and lacks significant commercial partnerships, which increases funding risk as its pipeline advances. Technical indicators for the stock also remain weak, and valuation metrics are challenged by negative earnings and the absence of dividend income.
More about Avacta Group plc
Avacta Group plc is a clinical-stage biotechnology and life sciences company focused on developing innovative cancer treatments. Its proprietary pre|CISION platform is designed to activate potent peptide drug conjugates within the tumour microenvironment using fibroblast activation protein (FAP). This approach aims to deliver highly effective therapeutic payloads directly to solid tumours while minimising systemic toxicity and improving dosing flexibility for patients.
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