Faron Touts Positive Results of Bexmarilimab in Refractory Melanoma Patients

Bexmarilimab is showing positive responses in the patients.

Bexmarilimab is showing positive responses in the patients. 

Faron Pharmaceuticals announced a new analysis that estimates 100% overall survival at 12-months for patients who experienced clinical benefit following treatment with bexmarilimab as part of the melanoma cohort in the ongoing Phase I/II Matins (Macrophage Antibody to Inhibit Immune Suppression) trial.

Feron highlighted two other positive results in its press release. 

There was a 30% clinical benefit rate seen following treatment with bexmarilimab in heavily pre-treated, checkpoint inhibitor refractory patient population.  Additionally, melanoma patients with low baseline levels of inflammatory cytokines in blood and high Clever-1 positivity in tumors are more likely to benefit from treatment with bexmarilimab and experience significant increases in serum interferon-gamma (INFy) during treatment.

The company will formally present its findings on the effectiveness of bexmarilimab at the 18th Congress of the European Association of Dermato-Oncology (EADO), being held in Seville, Spain, from April 21 to April 23. The event highlights new information on the diagnosis, prevention and treatment of dermato-oncologic diseases.

The working of Bexmarilimab

Bexmarilimab (formerly known as Clevegen) is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function.

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. 

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. 

"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 Faron’s chief medical officer, Marie-Louise Fjällskog, M.D., Ph.D. "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 rollout of new therapeutic approaches."

Data from 11 melanoma patients (including the full cohort of 10 patients in Part II and one additional patient with the same dosing regimen from Part I) who were refractory to checkpoint inhibition will be 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, and the median age of patients was 60.

The American Cancer Society estimates that in 2022, there will be 99,780 new melanoma cases diagnosed (about 57,180 in men and 42,600 in women) and 7,650 people are expected to die from melanoma (about 5,080 men and 2,570 women).

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