TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces 12-month top-line overall survival results from its Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab monotherapy in ten different hard-to-treat metastatic or inoperable solid tumor cohorts. The analysis showed that 65% (11/17) of patients who benefited from treatment with bexmarilimab (partial response + stable disease rate) were alive at 12-months compared to 11% (8/73) of patients who did not benefit from treatment. The strongest survival benefit was seen in checkpoint refractory melanoma and cholangiocarcinoma where 12-month survival was 100% among patients who benefited from bexmarilimab treatment and 0% for patients who did not benefit from treatment. The analysis includes 90 patients from the trial who received three courses of treatment and had their scheduled tumor imaging at cycle four and 12-month survival follow-up completed.

“The updated survival data from the MATINS trial are significant, especially when you consider the patient population in this trial,” said Daruka Mahadevan, M.D. Ph.D., Chief, Division of Hematology/Medical Oncology, Mays Cancer Center, University of Texas Health, San Antonio. “These are heavily pre-treated patients with significantly advanced disease. It’s highly encouraging that an anti-tumor immune response was activated and that two-thirds of the patients who benefited from treatment had a durable response lasting at least 12-months.”

The ongoing open label Phase I/II MATINS clinical trial is investigating the safety and efficacy of bexmarilimab, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. In the MATINS trial, bexmarilimab is being investigated as a potential monotherapy in patients with solid tumors who have exhausted all other treatment options. The most significant clinical benefit rate among the ten solid tumor cohorts was observed in cutaneous melanoma (30%), gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%) patients. Treatment with bexmarilimab continues to be well tolerated with no new safety signals reported and no treatment related adverse events resulting in a decrease or modification of dosing.

“One-year survival data is an important milestone in any cancer trial, and we are highly encouraged by the meaningful extension of life experienced by patients who benefited from bexmarilimab monotherapy,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “These data, along with the biomarker data we previously reported, are helping us design our upcoming registrational trials and further support our belief that bexmarilimab monotherapy can increase survival in patients with a variety of late-stage solid tumors.”

The Company will complete a detailed evaluation of the MATINS data and looks forward to sharing the results at an upcoming medical conference, as well as with regulatory authorities. Faron thanks the patients and investigators who are participating in the MATINS clinical trial. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 960914.