Faron Pharmaceuticals Limited (AIM:FARN) has secured a significant boost for its cancer immunotherapy programme, with UK regulatory authorities approving its BEXMAB trial and awarding bexmarilimab an Innovation Passport.
The drug, developed to treat relapsed or refractory Myelodysplastic Syndrome (r/r MDS), has been recognised under the Innovative Licensing and Access Pathway (ILAP), a framework aimed at speeding up access to cutting-edge therapies for patients with urgent medical needs.
The Innovation Passport, granted by the Medicines and Healthcare products Regulatory Agency (MHRA), provides enhanced regulatory support and collaborative opportunities with other health assessment bodies.
This status positions bexmarilimab for faster development and potential early access, reflecting its promise in addressing unmet medical needs. The decision was backed by an ILAP steering group including representatives from the MHRA, NICE, and other key organisations.
Faron also announced MHRA approval to expand its BEXMAB trial to UK sites.
This move will allow the inclusion of UK haematology patients, boosting recruitment and broadening the diversity of trial participants.
The expansion is expected to accelerate the trial’s progress, enhancing the study’s scope as Faron continues its efforts to advance promising cancer treatments. Recruitment at UK sites is set to begin imminently.
Faron CEO, Dr Juho Jalkanen, said: "At Faron, we understand the importance of actively engaging with regulatory authorities and, as a result of those interactions and the promising data generated to date, I am very pleased that the MHRA has recognised the potential of bexmarilimab to treat r/r MDS patients.
"Receiving ILAP designation, coupled with regulatory approval to conduct the BEXMAB trial in the UK, will allow us to accelerate the development of bexmarilimab and give UK patients access to a promising novel therapeutic option through participation in the study.
"We are looking forward to continuing our discussions with the MHRA to further expedite bexmarilimab's path to market for patients as soon as possible."