MATINS Trial in Cell Reports Medicine

Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine

• Bexmarilimab monotherapy shows efficacy in achieving disease control and prolonged survival in late-stage metastatic solid tumors
• CLEVER-1 targeting is safe and well-tolerated with no serious adverse effects
• Bexmarilimab induced macrophage activation and increased IFNɣ signaling in patients who achieved disease control and prolonged survival

Press release, December 07, 2023

TURKU, Finland / BOSTON, Massachusetts - December 7, 2023 - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces the publication of the full safety and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors in Cell Reports Medicine.

The publication, entitled, "Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: the phase I/II first-in-human MATINS trial" is available online at Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial: Cell Reports Medicine

"Positive Phase 1/2 data published in Cell Reports Medicine highlights bexmarilimab's potential to overcome cancer immune resistance by restoring macrophage immune function" said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS study. "We are pleased to see that bexmarilimab was safe and very well-tolerated, achieving disease control and prolonged survival in a proportion of patients with very late-stage solid tumors who have exhausted all standard treatment options. The observed stimulation of immune responses including macrophage activation increased IFNɣ signaling, and improved survival are particularly compelling given the challenging context of the late-stage, treatment-refractory disease patient population and the inclusion of nonimmunogenic cold tumors in this first-in-human trial. These results validate the macrophage-targeted approach and underscore bexmarilimab's potential as a novel immunotherapy in late-stage cancers, especially resistant to PD-1 blockade. We look forward to generating additional data with this novel and innovative macrophage-targeting immunotherapeutic antibody bexmarilimab."

Clever-1 is highly expressed by the most immunosuppressive macrophages and contributes to impaired antigen presentation and suppression of anti-tumor immunity. Bexmarilimab is a humanized monoclonal anti-CLEVER-1 antibody that activates the immune system and evokes anti-tumor responses. The Phase 1/2 first-in-human MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors. The monotherapy showed no dose-limiting toxicities and exhibited excellent safety and tolerability in over 200 patients. Observed disease control rates were associated with improved survival and were consistent with higher pre-treatment intratumoral CLEVER-1 levels and low baseline IFNɣ signaling that then increased during treatment. Transcriptomics profiling of the tumors demonstrated that bexmarilimab activates intra-tumoral macrophages and stimulates IFNɣ and T-cell receptors in a proportion of patients, which then leads to disease control and prolonged survival.

For more information on MATINS, please visit ClinicalTrials.gov and reference Identifier NCT03733990.

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 targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.