Inside Information: Faron announces encouraging first overall survival data from frontline higher-risk (HR) MDS patients in the BEXMAB phase 1/2 trial

Inside Information: After a median follow-up of 14.9 months, median overall survival has not yet been reached in frontline HR MDS without TP53 mutations, nor has it yet been reached for monoallelic TP53 mutated patients. For patients with biallelic TP53 mutations the median OS is 8.8 months in line with historical results in this highly aggressive population.

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 announced that it has conducted its first overall survival (OS) data cut from treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS) patients enrolled in the BEXMAB trial. At this time, after a median follow-up of 14.9 months, the only subgroup to have hit the median is the biallelic TP53 mutated population. This subgroup, historically associated with very poor outcomes, achieved a median OS of 8.8 months, which is in line with historical data and reassuring given the complex cytogenetics within the BEXMAB biallelic patient population. Other subgroups: monoallelic TP53 mutated and wildtype patients have still not reached their median OS.

The BEXMAB trial is an open-label Phase 1/2 study investigating bexmarilimab, Faron's novel anti-Clever-1 immunotherapy, in combination with standard-of-care azacitidine in patients with higher-risk myelodysplastic syndromes. Of the 21 treatment-naïve HR-MDS patients, 48% harboured TP53 mutations, a well-established adverse prognostic factor associated with inferior survival outcomes. Of the TP53 mutated patients (with known allele frequency data), 33% had monoallelic TP53 alterations, and 67% had biallelic TP53 alterations.

Survival follow-up is ongoing, and several patients remain alive and under follow-up, providing the opportunity for further maturation of the dataset over time.

“These results further support the potential of bexmarilimab in frontline TP53 wild-type and mutated HR-MDS patients, where significant unmet medical need remains," said Dr. Petri Bono, Chief Medical Officer of Faron Pharmaceuticals. "The data provide additional support as we continue preparations for BEXERA, our planned randomized study evaluating bexmarilimab in combination with azacitidine in frontline HR-MDS patients. We look forward to presenting the detailed full BEXMAB dataset at an upcoming scientific meeting later this year.”

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.