Researcher hails Faron’s MDS trial results as ‘highly encouraging’

A researcher assessing the potential of Faron Pharmaceuticals Limited's (AIM:FARN) lead asset has described the latest cancer trial data as “highly encouraging”.

The comments from Dr Naval Daver, of MD Anderson Cancer Center in Texas, accompanied the latest study read-out, which showed improved survival in patients with advanced myelodysplastic syndromes (MDS), a form of bone marrow cancer that is difficult to treat.

Daver said the combination of Faron’s investigational drug bexmarilimab with standard therapy azacitidine, showed particular promise in patients who had failed on prior treatment.

“This data with bexmarilimab plus azacitidine is highly encouraging, especially in the relapsed and refractory MDS setting where treatment options are limited and outcomes remain poor,” he said.

The phase II readout, presented at the ASCO 2025 conference in Chicago, showed a median overall survival of 13.4 months in 32 patients with relapsed or refractory MD, more than double the five to six months typically expected with current standard-of-care drugs.

Daver, who led the ASCO presentation, added that the response rates and signs of immune activity in the bone marrow suggest the combination could help more patients reach bone marrow transplant, the only potentially curative option.

“Seeing promising survival outcomes and overall response rates in patients after HMA failure highlights the potential of this approach," he explained.

"The observed immune activation in the bone marrow further reinforces the mode of action of bexmarilimab and offers hope for bridging patients towards a bone marrow transplant, which could lead to a possible cure.”

In newly diagnosed patients, results were also strong. Among 18 treatment-naïve participants, 72% responded to treatment, and 56% achieved a complete response based on updated 2023 clinical criteria.

Most showed a reduction in bone marrow cancer cells, and over half saw those cells eliminated entirely.

Faron said most patients across both groups were classified as high or very high risk. Based on the results and previous feedback from the US Food and Drug Administration, the company now plans to begin a phase III trial in newly diagnosed high-risk MDS patients.

Faron CEO Juho Jalkanen said: “These amazing results reinforce our confidence in bexmarilimab’s potential to transform care for patients with high-risk MDS.

"This data not only strengthens the rationale for advancing to a randomised phase III trial in frontline HR-MDS, in line with FDA guidance, but also marks a significant step forward in our clinical development strategy towards approval.”