Faron Pharmaceuticals gets positive feedback from FDA meeting

Clinical-stage biopharmaceutical company Faron Pharmaceuticals said on Wednesday that it had received positive feedback from the US Food and Drug Administration (FDA) on the development of its precision immunotherapy asset ‘bexmarilimab’.

The AIM-traded firm said the FDA provided recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumours, following an end-of-phase one and two meeting held earlier in March.

Its phase one and two ‘MATINS’ trial was investigating bexmarilimab in multiple cancer indications.

The official meeting minutes aligned with the FDA's ‘Project Optimus’ initiative, which was aiming to reform dose optimisation and selection paradigm in oncology drug development.

Faron said the MATINS study was aiming to comply with the initiative through multiple dose and indication arms of the study.

The FDA provided positive meeting feedback, the board said, which further aligned the agency's views on bexmarilimab with the company's.

It said the FDA stated that the completed toxicology studies were adequate to support further clinical development of single-agent bexmarilimab into a registration trial.

Additionally, the selection of one milligram per kilogram IV Q3W as a dose for further evaluation appeared “reasonable”, although additional data was required to establish the recommended phase two and three dose for specific cancers.

The company said the FDA also provided valuable feedback and guidance on 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 chief executive officer Markku Jalkanen.

“As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market.”

Faron had previously announced a meeting with the agency would occur this quarter.

“FDA's feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab's future strategy," added chief medical officer Marie-Louise Fjällskog.

At 1443 GMT, shares in Faron Pharmaceuticals were up 0.8% at 315p.

Reporting by Josh White for Sharecast.com.