Cancer treatment has long focused on directly killing malignant cells, yet the tumour microenvironment (TME)—comprising about half of all tumour cells including fibroblasts, blood vessels, and fat cells—plays a critical role in supporting cancer growth, invasion, and resistance to therapy. Traditional chemotherapies often leave the TME largely untouched, enabling cancer relapse and progression. Kesonotide, a first-in-class dual anti-inflammatory and chemotherapy drug offers a novel approach that simultaneously targets both cancer cells and their supportive TME, potentially revolutionizing solid cancer treatment.

Kesonotide uniquely combines anti-inflammatory and cytotoxic effects. It blocks inflammatory proteins such as human group IIA secreted phospholipase A2 (hGIIA) from activating cytoskeletal proteins, particularly vimentin. Vimentin is essential for cancer cell survival, division, and the formation and maintenance of the TME. By inhibiting vimentin’s abnormal cancer-driven functions—such as extracellular matrix formation and epithelial-mesenchymal transition (EMT), which promotes cancer invasiveness—kesonotide disrupts both the tumour cells and their microenvironment without harming immune or healthy cells. This selective targeting explains its lack of known toxicity, as it primarily affects stressed cells like cancer cells.

Following a successful first-in-human pilot study in 12 men with advanced prostate cancer that confirmed kesonotide’s oral bioavailability, safety, and tolerability, Filamon has secured regulatory approval to commence the ADVICE Phase Ib/IIa clinical trial. This adaptive, multi-centre, open-label study will enroll up to 80 patients with advanced solid cancers—including lung, prostate, breast, ovary, pancreas, head & neck, large bowel, and brain (glioblastoma)—who have progressed despite standard treatments or are unable or unwilling to use them.

The ADVICE trial, starting mid-2025, will administer daily oral kesonotide monotherapy for up to six months. Its adaptive design allows modifications based on interim results to efficiently identify cancer types most responsive to treatment, focusing subsequent study phases accordingly.

Clinical trial.