Avacta Group has announced the dosing of the first patient in its Phase I clinical trial of AVA6103 (FAP-Exd), a second-generation peptide-drug conjugate (PDC) developed using its proprietary pre|CISION delivery platform. The milestone follows the company’s recent Euro 10 million equity raise, strengthening its financial position as it advances its oncology pipeline.

AVA6103 is designed to deliver a sustained release of exatecan, a topoisomerase I inhibitor, directly into the tumour microenvironment. The approach aims to address key limitations of conventional therapies, including short drug half-life and systemic toxicities, by enabling more targeted and controlled drug release.

The FOCUS-01 Phase I trial will enrol approximately 144 patients across two parallel arms, targeting four FAP-positive solid tumours: cervical, gastric, pancreatic and small cell lung cancer. The study will evaluate safety, fibroblast activation protein (FAP) release kinetics and preliminary efficacy. Early data from the Phase Ia dose-escalation stage are expected in late 2026, with the Phase Ib dose-expansion phase anticipated to begin in early 2027.

The study is being conducted in collaboration with Tempus AI, which is supporting patient selection through advanced data-driven insights to identify individuals most likely to benefit from targeted therapy within FAP-sensitive tumour environments.

Avacta’s earlier candidate, AVA6000 (FAP-Dox), has already demonstrated proof of concept for the pre|CISION platform, showing improved safety and tolerability compared to standard doxorubicin, including the absence of cardiotoxicity. Building on this, the company’s second- and third-generation PDCs are expected to further refine payload delivery, enabling sustained release and potentially dual-payload targeting strategies.

Following the oversubscribed fundraise, Avacta’s cash runway is projected to extend into early 2027, allowing it to retain full ownership of its pre|CISION assets as it approaches key clinical and commercial inflection points. The company is currently valued at approximately Euro 471 million ( USD 603 million), reflecting investor confidence in its targeted oncology platform.