- Faron Pharmaceuticals Oy (DI)
- 20 October 2025 10:04:48
Source: Sharecast
The AIM-traded firm said the data, presented at the European Society for Medical Oncology (ESMO) Congress 2025 by Dr Mika Kontro of Helsinki University Hospital, confirmed an 85% objective response rate and a 45% complete remission rate among 20 evaluable treatment-naïve patients treated with bexmarilimab in combination with azacitidine.
It said 55% of those patients showed full clearance of bone marrow blasts, while those with lower baseline blast counts (<5%) achieved a 100% response rate - one of the strongest results ever reported in this population.
The updated analysis also found a statistically significant correlation between deeper engagement of the Clever-1 receptor - bexmarilimab’s target - and improved clinical outcomes.
“The BEXMAB data are encouraging, and the new biomarker analysis provides a clear pharmacodynamic rationale for bexmarilimab’s clinical activity,” said Dr Kontro.
“The direct correlation between how deeply we engage the Clever-1 target in the bone marrow and a patient’s clinical response reinforces the drug’s mechanism.
“The 100% ORR in patients with low blast counts suggest that this therapy may help in a population where current investigational treatments, including Bcl-2 inhibitors, have significant limitations.”
In patients who had failed prior hypomethylating agent therapy, the bexmarilimab and azacitidine combination achieved a 63% response rate and median overall survival of 13.4 months, despite nearly a third having previously received the Bcl-2 inhibitor venetoclax.
Across all cohorts, 23% of participants were successfully bridged to potentially curative stem cell transplants.
Faron said the combination continued to be well tolerated, with a safety profile comparable to or better than azacitidine alone.
Only 36% of treatment-emergent adverse events were considered related to bexmarilimab, with no grade five events reported.
Following guidance from the US Food and Drug Administration in August, Faron has begun preparing the dose-optimisation stage of its phase two and three trial, which is expected to transition into a registrational study with the potential for accelerated approval.
“The selection of this BEXMAB data for an oral presentation at ESMO is a significant external validation of our science and the clinical potential of bexmarilimab,” said Dr Maija Hollmén, chief scientific officer of Faron Pharmaceuticals.
“These findings help us understand why the drug works and for whom it works best.
“The clear biomarker impact in the bone marrow and unique efficacy in patients with low blast counts highlights Bex’s ability to change the course of the disease and provides a solid foundation for our late-stage clinical development, bringing this promising therapy to patients who desperately need better options.”
At 0912 BST, shares in Faron Pharmaceuticals were up 1.22% at 182.2p.
Reporting by Josh White for Sharecast.com.
