Faron Pharmaceuticals may be allowing itself a moment to feel clever. The Finnish biotech posted data on its tumor-associated macrophage candidate bexmarilimab, linking its antibody to one unconfirmed partial response in a cohort of 11 checkpoint inhibitor refractory melanoma patients.
Bexmarilimab hits Clever-1, a scavenger receptor linked to the spread of cancer. Inhibiting Clever-1, also known as Stabilin-1 and FEEL-1, may change macrophages and monocytes from immunosuppressive to pro-inflammatory and thereby activate T-cell responses, leading Faron to test its candidate as a single agent and in combination with checkpoint inhibitors in solid tumor patients.
Faron arrived at the Congress of the European Association of Dermato-Oncology this week armed with a slice of data from the monotherapy trial. The melanoma cohort is one of 10 tumor types enrolled in the second part of the phase 1/2 study, which is giving bexmarilimab as a single agent every three weeks.
One of the patients had a partial response after two cycles of bexmarilimab but was discontinued before the confirmatory scan. A further three patients had stable disease. Faron framed the melanoma data as indicating a “compelling 30% clinical benefit rate,” although it provides further evidence that bexmarilimab struggles to drive responses when given as a monotherapy.
The claim that the data are compelling reflects the patient population, with Faron enrolling individuals who were refractory to checkpoint inhibitors. Such patients have limited treatment options but, even so, there are doubts about whether stable disease is enough of a win. Investors were relatively unmoved by the data, with Faron’s London-traded stock having risen less than 3% to 2.35 pounds sterling ($3.03) by 10:48am U.K. time.
The company sees opportunities to improve the response rate. Biomarker analyses suggest patients with low baseline levels of inflammatory cytokines are most likely to benefit from bexmarilimab, potentially giving physicians a way to stratify the melanoma population using a standard blood test. Faron is also studying the drug in combination with checkpoint inhibitors and in blood cancers.
The studies are central to Faron’s effort to recover from the failure of a pivotal trial of its former lead candidate traumakine in 2018. The biotech tried to resurrect traumakine as a COVID-19 treatment but recently shut its clinical trial because of a shortage of potential participants.