Inside Information: Faron announces encouraging first overall survival data from frontline higher-risk (HR) MDS patients in the BEXMAB phase 1/2 trial
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Faron Pharmaceuticals Ltd | Company announcement | July 27, 2026 at 09:00:00 EEST
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.”
For more information, please contact:
| IR Partners, Finland (Media) Kare Laukkanen | +358 50 553 9535 / +44 7 469 766 223 kare.laukkanen@irpartners.fi | |
| FINN Partners, US (Media) Alyssa Paldo | +1 847 791-8085 alyssa.paldo@finnpartners.com | |
| Cairn Financial Advisers LLP (Nominated Adviser and Broker) Sandy Jamieson, Jo Turner | +44 (0) 207 213 0880 | |
| Sisu Partners Oy (Certified Adviser on Nasdaq First North) Juha Karttunen Jukka Järvelä | +358 (0)40 555 4727 +358 (0)50 553 8990 |
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.
Forward-Looking Statements
Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.
A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements.
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