Faron Pharmaceuticals announces positive FDA feedback for solid tumour therapy

pharmafile | March 22, 2023 | News story | Research and Development  

Faron Pharmaceuticals, a clinical stage biopharmaceutical company, has revealed positive FDA feedback and recommendations for its monotherapy for solid tumour drug, bexmarilimab.


Bexmarilimab is a novel anti-CLEVER-1 humanised antibody which aims to provide permanent immune stimulation for rare or hard to reach cancers through targeted myeloid function.


The FDA feedback comes after the MATINS phase 1/2 clinical trial, which evaluated bexmarilimab’s toxicity and dosage. The study found bexmarilimab’s toxicity to be tolerable as a monotherapy and its dosage (1 mg/kg IV Q3W) to be “reasonable”, yet more research is needed into specific cancers to ensure the dosage is correct for the type. More than 200 patients were treated, with an approximate 30% clinical benefit rate in several tumour types.


These comments align with the FDA’s Project Optimus initiative, which is aiming to reform dose optimisation and the selection paradigm for oncology drug development.


Markku Jalkanen CEO of Faron, stated: “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. As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market.”


Chief medical officer Marie-Louise Fjällskog commented, “[The] FDA’s feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab’s future strategy. We thank the FDA for its time and consideration of our briefing package and anticipate additional fruitful interactions.”


James Spargo

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