TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company, today announces the finalization of agreements to initiate the BLAZE trial, a new investigator-initiated trial (IIT) in the UK. The trial is conducted via a strategic collaboration with The Institute of Cancer Research, London (ICR), operating in partnership with The Royal Marsden NHS Foundation Trust. This collaboration leverages the world-class expertise of these globally recognized leaders in cancer research, innovation, and treatment.

The Phase I/II BLAZE trial will investigate Faron’s lead asset, bexmarilimab, in combination with the anti-PD-1 checkpoint inhibitor, zimberelimab provided by Gilead Sciences, for patients with metastatic non-small cell lung cancer (NSCLC) and melanoma who have developed resistance to prior anti-PD-1-based immunotherapy and progressed within three months of the last anti-PD-1 treatment. The trial will explore a novel approach by first priming patients with bexmarilimab monotherapy, followed by the combination of bexmarilimab and zimberelimab, aiming to resensitize the tumors back to anti-PD-1 treatment after disease progression.

Dr. Anna Minchom, MD, BCh, MB, MRCP, Team Leader at The Institute of Cancer Research, London (ICR) and a Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and principal investigator of the trial said, “Resistance to immunotherapy remains a significant hurdle for many patients with lung cancer and melanoma. There is a strong scientific rationale that tumour-associated macrophages are key culprits in this process. By targeting them with bexmarilimab before re-introducing an anti-PD-1 treatment, we are testing a novel strategy to reverse this resistance. We look forward to gathering vital clinical and translational data from this study.”

Addressing a critical unmet need

Resistance to first-line anti-PD-1 immunotherapy is one of the most significant challenges in modern cancer immunotherapy era. While checkpoint inhibitors have revolutionized treatment, the majority of patients with advanced melanoma and lung cancer eventually see their disease progress. This acquired resistance represents a major and growing unmet medical need, as effective subsequent treatment options are very limited. There is strong evidence that tumour-associated macrophages (TAMs) create an immunosuppressive tumour microenvironment that drives this resistance and could be overcome by removing the immunosuppression by anti-Clever-1 mAb bexmarilimab.

Dr. Juho Jalkanen, CEO of Faron, said, “We are thrilled to collaborate with the esteemed teams at the ICR and The Royal Marsden on the BLAZE trial. We believe bexmarilimab’s unique mechanism of reprogramming macrophages has the potential to resensitize tumours to immunotherapy, offering new hope for patients who have exhausted their treatment options. This trial is designed to deliver proof-of-concept data for this critical application.”

The robust clinical and translational data generated from the BLAZE trial could accelerate the development of new immunotherapy strategies for PD-1 resistant patients. Success in this trial could pave the way for broader applications of macrophage-targeted therapies in solid tumors, not only to overcome acquired resistance but also to potentially make ‘cold’ tumours, which are non-responsive from the start, sensitive to checkpoint inhibitors.

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About bexmarilimab
Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab is being evaluated in the U.S. and globally as an anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Zimberelimab is an investigational molecule that has not received approval from any regulatory authority worldwide. Its safety and efficacy have yet to be established.

About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The company’s lead asset, bexmarilimab, is a novel macrophage-guiding immunotherapy being investigated in multiple oncology settings. Further information is available at www.faron.com.