Faron Pharmaceuticals, a clinical-stage biopharmaceutical company based in Finland, has announced that it has treated 255 patients with its experimental bexmarilimab (bex) treatment, which helps the body's immune system target and destroy treatment-resistant cancer cells.
Bexmarilimab is a humanized monoclonal antibody molecule that binds to Clever-1, an immunosuppressive scavenger receptor found on macrophages, which are white blood cells that engulf and kill pathogens, remove dead cells, and stimulate the action of other immune system cells. Clever-1 is associated with poor survival with cancer by supporting tumor growth and metastasis formation. By binding with Clever-1, bex allows macrophages to normally present the cancer cells they capture to the immune system, which can then begin attacking the tumor.
In Faron's first human study on bex, it treated 219 patients in advanced stages of 10 different solid tumor cancer types, including gastric, pancreatic, liver, and breast cancer, and a further 36 in hematological malignancies. According to Faron's CEO Juho Jalkanen, MD, PhD, the company screened various cancer types to come up with the 10 types included in the study. It found that the type of cancer didn't matter as much as knowing which specific macrophages to target. The study also resulted in stopping the progression of cancer in between 30% and 40% of patients. However, because the cancer is already quite advanced, bex can no longer get rid of it at that point.
Despite this, Dr. Jalkanen says that it is still a positive development, and it shows that intervening with bex during the earlier stages of cancer will likely show more promise. Furthermore, immunotherapies such as bex can be combined with other treatments, such as chemotherapy, without adding toxicity, as chemotherapy is already quite toxic.
"We're very confident with the safety profile of bex, and it does not cause side effects such as hair loss," Dr. Jalkanen says. "It is very well tolerated by patients, with many of them reporting no negative experiences associated with taking the drug. The purpose of bex is to remove treatment resistance, making otherwise resistant cancers responsive to other currently available treatments. We aim to add efficacy without increasing toxicity."
Following these promising results and other breakthroughs in drug development, Faron Pharmaceuticals has secured 30 Million in its most recent funding round, demonstrating investors' belief in bex's potential to be a valuable treatment for various types of cancer. Faron has now secured funding to continue with its Phase II trials and will continue looking for investment to scale up its manufacturing capabilities to become a Phase III-ready company. It also plans to apply for accelerated approval with the US FDA possibly even as early as 2025, allowing it to bring bex to the market faster, filling the unmet medical needs of patients with treatment-resistant cancers.
