Faron Pharmaceuticals Oy has released initial positive results from the Phase 2 part of the BEXMAB trial, demonstrating promising outcomes for patients with myelodysplastic syndrome (MDS) who have failed hypomethylating agent (HMA) treatment. The trial showed an objective response rate (ORR) of 79% in 14 MDS patients who had relapsed or were refractory to HMA, with an estimated median overall survival (mOS) of approximately 13 months, compared to the historical 5-6 months under standard care. These results build on the earlier positive Phase 1 findings, indicating the potential of the novel combination treatment.
The BEXMAB Phase 1 results had already shown a high ORR of 87.5% among HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. The Phase 2 data further confirmed the treatment's efficacy, with 79% ORR and a true remission rate of 64% in the 14 patients. Notably, some patients achieved complete response, marrow complete remissions, and partial response, with two patients proceeding to bone marrow transplantation, a rare occurrence in this patient population.
Dr. Amer Zeidan, a leading investigator on the trial, emphasized the significance of these findings, stating that the management of higher risk MDS after HMA failure is a critical unmet clinical need, and bexmarilimab shows promise in addressing this gap. Dr. Juho Jalkanen, CEO of Faron, expressed the company's commitment to advancing bexmarilimab to market, recognizing the urgent need for new treatment options in relapsed/refractory MDS.
The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in acute myeloid leukemia (AML) and MDS. Bexmarilimab, which targets Clever-1, has shown potential in limiting cancer cell replication, increasing antigen presentation, and igniting an immune response. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, making bexmarilimab a promising candidate for addressing the unmet clinical needs in MDS patients.
Faron will be hosting a virtual webinar to discuss these data, providing an opportunity for further insights into the promising results of the BEXMAB trial.