Faron Pharmaceuticals Oy (AIM:FARN, OTC:FPHAF) said the first patient has been dosed in its phase I/II BEXMAB study, which is investigating the company’s bexmarilimab immunotherapy asset in combination with standard of care (SoC) in multiple hematological malignancies.
The trial marks the first time bexmarilimab is being assessed as part of a clinical study in hematologic malignancies, the clinical stage biopharmaceutical company said in a statement.
The primary objective of the study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended phase II dose.
"We think that bexmarilimab and azacitidine have the potential to work synergistically by controlling disease progression and activating an immune response. This could provide a deeper and more durable clinical benefit compared to what we have seen with monotherapy,” said Mika Kontro, MD, Ph.D., Helsinki University Hospital Comprehensive Cancer Center and principal investigator of the BEXMAB trial.
Faron said secondary objectives of the study include characterising the pharmacokinetic profile of bexmarilimab in combination with SoC treatment and to assess the immunogenicity of the asset.
It also said that, based on safety data, the trial may be expanded to a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia (AML) patients who are not able to tolerate chemotherapy.
"We are excited to kick off this important trial, a significant achievement in our development strategy targeting myeloid cell function to overcome immune suppression in the tumour microenvironment," said Marie-Louise Fjällskog, MD, Ph.D., chief medical officer of Faron.
"Extending our clinical research into the combination setting is a logical next step as it allows us to build on bexmarilimab's monotherapy efficacy and safety profile and will help us uncover its full therapeutic potential in tumour types where high Clever-1 expression is known to adversely impact patient outcomes."