Faron Provides Update on Investigator-Initiated Trial Portfolio for Bexmarilimab

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a global, clinical-stage biopharmaceutical company focused on creating innovative cancer treatments that leverage the patient’s own immune system, today provides an update on its portfolio of Investigator-Initiated Trials (IITs) evaluating bexmarilimab, its wholly owned anti-Clever-1 immunotherapy, in multiple oncology indications. The update covers five IITs in solid tumors and hematological malignancies, reflecting both advances and adjustments across the program.

BLAZE: Investigators update combination treatment to approved standard-of-care nivolumab

The investigators of the BLAZE IIT, led by The Institute of Cancer Research (ICR) and conducted at The Royal Marsden NHS Foundation Trust in London, UK, as well as other leading UK hospitals, have updated the trial’s anti-PD-1 combination drug to nivolumab (Opdivo®), a fully approved, globally used standard-of-care anti-PD-1 inhibitor. The trial has received the necessary regulatory and ethical approvals and is advancing towards first patient enrolment.

The BLAZE trial is a Phase 1/2 evaluating bexmarilimab in combination with nivolumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma who have developed resistance to prior anti-PD-1-based immunotherapy. The trial investigates a sequential approach: patients first receive a run-in dose of bexmarilimab to reprogram the immunosuppressive tumor microenvironment, followed by the combination of bexmarilimab and nivolumab, with the aim of resensitizing tumors to checkpoint inhibition. Using nivolumab as the combination backbone is scientifically meaningful, because its efficacy is well characterized. Therefore, clinical activity observed in the combination treatment can be better understood.

“The current design of BLAZE allows us to generate clear and interpretable data on bexmarilimab’s ability to overcome PD-1 resistance. Nivolumab is one of the most extensively studied and used anti-PD-1 therapies in the world, and its efficacy and safety profile is well established. This provides a robust baseline against which to assess whether bexmarilimab can restore sensitivity to checkpoint inhibition in this difficult-to-treat population. We look forward to opening enrolment,” said Dr Anna Minchom, MB, BCh, FRCP, MD (res), Principal Investigator of the BLAZE trial and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust.

BEXAR: Regulatory approval received in frontline soft-tissue sarcoma

The BEXAR trial has received the necessary regulatory and ethical approvals and is advancing towards first patient recruitment. BEXAR is a randomized Phase 1b/2 IIT sponsored by MEDSIR and conducted at six Spanish hospitals and led by Dr. Cesar Serrano at the University Hospital Vall d'Hebron in Barcelona, Spain.

The trial evaluates bexmarilimab in combination with standard-of-care doxorubicin in patients with first-line metastatic soft-tissue sarcoma. The expression of bexmarilimab’s target, Clever-1, in soft-tissue sarcomas is among the highest observed across tumor types, providing a strong biological rationale for the use of bexmarilimab in this setting. Additionally, bexmarilimab's observed effects on hematopoiesis in the bone marrow may help offset the myelosuppressive effects of doxorubicin. The trial design includes exploratory endpoints to further evaluate this hypothesis in the sarcoma setting.

“Soft-tissue sarcoma is a disease where patients desperately need new treatment options. The biology here is compelling as these tumors are rich in immunosuppressive macrophages that we believe are actively driving resistance to treatment. We are excited to begin testing whether bexmarilimab can overcome that resistance," said César Serrano, M.D., PhD, Group Leader of the Sarcoma Translational Research Program at the Vall d'Hebron Institute of Oncology and Principal Investigator of the BEXAR trial.

FINPROVE: Bexmarilimab cohort not to proceed

The FINPROVE trial is an ongoing national, investigator‑initiated precision medicine study sponsored by Helsinki University Hospital, designed to evaluate targeted treatment approaches across multiple tumor types. Following a regulatory review by the Finnish Medicines Agency (Fimea), the proposed bexmarilimab cohort was considered incompatible with the FINPROVE platform trial, which focuses primarily on marketed therapies with established and approved patient selection strategies. This outcome does not impact Faron’s broader development program for bexmarilimab.

Forward-looking pipeline progress in hematological malignancies

Two further IITs continue to advance through active protocol development and regulatory submission preparations. The BEAM-X trial, led by the Nordic AML Group, will evaluate bexmarilimab in patients with measurable residual disease-positive acute myeloid leukemia (AML) following allogeneic stem cell transplantation. In parallel, the IIT sponsored by City of Hope National Medical Center in the United States, is planned to evaluate bexmarilimab and orally administered decitabine-cedazuridine (Inqovi®) in relapsed or refractory myelodysplastic syndromes (r/r MDS). Further updates on both IITs will be provided in due course.

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 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 is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase 1/2 clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

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