Juho Jalkanen, CEO of Faron
Juho Jalkanen, CEO of Faron

In a year already marked by critical scientific milestones, Faron Pharmaceuticals is set to take center stage once again. The clinical-stage biopharmaceutical company has announced that detailed Phase II data from its BEXMAB study evaluating bexmarilimab (bex), a novel immunotherapy targeting Clever-1, has been accepted for oral presentation at the 19th International Congress of Immunology (IUIS) in Vienna, Austria, from August 17 to 22, 2025.

This development is particularly significant given the current landscape of treatment for high-risk myelodysplastic syndromes (HR-MDS), a rare and aggressive group of bone marrow disorders with limited therapeutic options and poor prognoses, especially for patients who relapse or fail frontline hypomethylating agents (HMAs).

Standard treatments have seen little advancement in recent decades, with response rates in the relapsed/refractory setting often below 10% and median overall survival typically less than six months. Immunotherapies targeting the tumor microenvironment, particularly macrophage-mediated immune resistance, represent a promising new frontier in hematology. Bex's ability to reprogram immunosuppressive macrophages and enhance anti-tumor immune responses marks a major shift from traditional cytotoxic approaches and has the potential to redefine the standard of care for HR-MDS and other difficult-to-treat malignancies.

The company's inclusion in the oral sessions, one of the most prestigious scientific categories at IUIS, signals a rising recognition of bex's potential to change the treatment landscape for HR-MDS. This is the latest in a series of high-profile scientific endorsements for Faron, following similar honors at the American Society of Clinical Oncology (ASCO) and the International MDS Symposium earlier this year.

Bex is Faron's first-in-class anti-Clever-1 monoclonal antibody designed to reprogram immunosuppressive macrophages in the bone marrow. When combined with azacitidine, a current standard-of-care hypomethylating agent, the therapy aims to overcome treatment resistance and restore the body's ability to combat cancerous cells, a vital advancement for a disease that has long been resistant to effective treatment.

At IUIS 2025, Dr. Mika Kontro, MD, PhD, will deliver a presentation titled "Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study." The talk will highlight both frontline HR-MDS patients and those with relapsed/refractory (r/r) disease who have failed prior HMA therapy.

According to early disclosures, the data set includes impressive objective response rates and significant reductions in bone marrow blast counts, especially notable in a population where few therapeutic options remain.

Acceptance into IUIS's oral presentation track is not just a ceremonial nod. It's a peer-reviewed endorsement from one of the most rigorous scientific communities in immunology. For Faron, it is another critical validation of its mission: to address treatment-resistant diseases through bold immunological strategies.

"We are thrilled to see bex's data receive acceptance for oral presentation at IUIS, following similar recognition at MDS and ASCO," states Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "This continued momentum reinforces our belief that bex holds real promise as a much-needed therapeutic option for patients with higher-risk MDS, a rare and challenging condition with few effective treatments."

The past year has been pivotal for Faron. Following its positive Phase II results announced at ASCO, where bex achieved a median overall survival of 13.4 months in r/r MDS patients, more than double historical norms, the company has rapidly accelerated its development roadmap.

"We're not just excited by the numbers," Dr. Juho affirms. "We're driven by what this could mean for real people living with a devastating illness. If we can offer them a longer, better-quality life, we've done something truly meaningful."

With preparations underway for a registrational trial and ongoing regulatory engagement, Faron is also eyeing accelerated approval pathways. According to the company, upcoming interactions with the U.S. Food and Drug Administration will focus on confirming the new composite complete response (cCR) endpoints outlined by the IWG 2023 criteria, which link closely to survival and long-term outcomes.

Though much of the spotlight is on MDS, bex is part of a larger strategy: to harness the immune system's overlooked components to address immune resistance across a range of hard-to-treat cancers. Faron's broader pipeline reflects this ambition, with additional studies underway in acute myeloid leukemia (AML) and other indications where macrophage manipulation could yield significant benefits.

But for now, all eyes are on Vienna, where the company's work will once again be put to the test, and, it hopes, further cement its place among the most exciting innovators in oncology.