Faron Pharmaceuticals, a Finnish clinical-stage biopharmaceutical company focused on tackling cancers, has received approval from the British authorities to proceed with research into cancer immunotherapy.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has signed off a BEXMAB study – an open-label Phase I/II clinical trial – while its lead drug candidate Clevegen has received an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP).
Faron’s drug candidate, also called bexmarilimab, is an investigational immunotherapy designed to overcome resistance to existing treatments for blood cancer and optimise clinical outcomes by targeting myeloid cell function and igniting the immune system. The drug binds to an immunosuppressive receptor and alters the tumour microenvironment.
Juho Jalkanen, chief executive of Faron, said that the approvals would allow the company to accelerate the development of bexmarilimab and “give patients in the UK access to a promising novel therapeutic option through participation in the study”.
The ILAP was introduced by the MHRA in 2021 to give patients quicker access to treatments and therapies for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. It includes enhanced regulatory support from the MHRA and provides collaborative opportunities with health technology assessment bodies and other stakeholders to accelerate the development of new medicines.
In late November, the company reported initial positive results from its ongoing BEXMAB study with a median survival rate more than double the standard rate at 13.4 months.
The company has said that it intends to present a full analysis of the data at the American Society of Hematology (ASH) Annual Meeting on 9 December in San Diego, US.
Faron Pharmaceuticals has been listed in London on the London Stock Exchange’s Alternative Investment Market (AIM) since November 2015. Its shares jumped 6.25% on the news.
