On April 21, 2022 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, reported that results from the melanoma cohort in the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the 18th Congress of the European Association of Dermato-Oncology (EADO), being held in Seville, Spain, April 21 to April 23, 2022 (Press release, Faron Pharmaceuticals, APR 21, 2022, View Source [SID1234612830]).

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The melanoma cohort is one of the ten advanced treatment-resistant solid tumor types included in Part II (110 patients) of the MATINS study, which is investigating the potential of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, as a monotherapy. Bexmarilimab targets tumor associated macrophages, which are known to be immunosuppressive, make up nearly 50% of the tumor mass, and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. As previously communicated, melanoma is among five different tumor types from the original 10 studied to have shown the strongest clinical benefit rate (CBR = partial response or stable disease) – 30% – alongside gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%), following treatment with bexmarilimab.

Data from 11 melanoma patients (including the full cohort of 10 patients in Part II and one additional patient with same dosing regimen from Part I) who were refractory to checkpoint inhibition are being presented at the congress. All patients were treated with 1mg/kg of bexmarilimab monotherapy, every three weeks. The median number of previous treatment lines was three, the median age of patients was 60.

· Of the 11 patients, four experienced clinical benefit – one patient had a partial response after two cycles of bexmarilimab (tumor growth reduced by 40% from baseline) but was discontinued before a confirmatory scan was performed. Three patients had stable disease (i.e., clinical benefit rate of 30% in Part II).

· Current estimates for 12-month survival in Part II melanoma cohort were 100% for the patients who experienced clinical benefit following treatment compared to 33.3% of non-CBR patients.

· A preliminary biomarker analysis including the melanoma cohort showed that patients with higher intra-tumoral Clever-1 positivity and low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha were more likely to experience clinical benefit following treatment with bexmarilimab. Among those patients who experienced clinical benefit, a marked rise in serum IFNy levels was seen during treatment. IFNy is a necessary pro-inflammatory cytokine for response to checkpoint inhibitors like PD-1/L1, highlighting bexmarilimab’s combination potential.

"This rate of clinical benefit is particularly striking when you consider these are heavily pre-treated patients, all of whom were refractory to currently approved checkpoint inhibitor therapy," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "Bexmarilimab’s ability to ignite an immune response in these patients means that it may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1/L1 blockade."

"Additionally, the biomarker analysis among melanoma patients is consistent with our broader analyses and suggests that two cytokines, which can be measured by a standard blood test as part of a patient’s routine care, could hold the key to understanding which patients will gain the greatest benefit from this novel immunotherapy. Knowing which patients are most likely to respond to treatment is key to both the development process and the successful roll out of new therapeutic approaches."