Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) said it received positive feedback and a green light from the US Food and Drug Administration (FDA) for further trials of cancer drug bexmarilimab as a monotherapy for solid tumours.
"FDA's feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab's future strategy," said Marie-Louise Fjällskog, Faron’s chief medical officer.
In a statement, Faron said the FDA had made its indication following a review of the initial data from the MATINS trial and had agreed with the company’s dose escalation plans.
The phase I/II MATINS trial is investigating bexmarilimab, an immunotherapy drug, in multiple cancer indications.
FDA feedback concluded that the completed toxicology studies are adequate to support further clinical development of single-agent bexmarilimab into a registration trial.
That selection of 1 mg/kg IV Q3W as dose for further evaluation appears reasonable, although additional data are required to establish the recommended phase II/III dose for specific cancer(s).
The FDA also gave guidance about the further development of a simple, validated staining assay to identify patients with CLEVER-1 positive tumours for clinical trial inclusion.
"We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumours," said CEO Markku Jalkanen.
Faron had previously announced a meeting with the agency would occur this quarter.