Faron Pharmaceuticals Oy has given an update on its phase I/II BEXMAB study, investigating bexmarilimab. Bexmarilimab is Faron’s wholly owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.
The Finnish company said an azacytidine-refractory acute myeloid leukemia (AML) patient with partial responses as communicated on October 31, 2022, achieved a complete remission, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles.
The second patient, recently diagnosed with myelodysplastic syndrome (MDS), showed early signs of efficacy, with reduced blast counts. This pattern is similar to the first patient and as such the patient could be considered a partial responder.
The remaining patients of the first cohort have reported stable disease (SD) status.
The study also shows bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine.
The company said a study expansion to major hematological U.S. centers is ongoing.
Primary objective
The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended phase II dose. Secondary objectives include characterizing bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity. The initial treatment efficacy is followed by measuring cancer cell blast number in blood and bone marrow.
The BEXMAB study has opened the second predefined weekly dosing level of 3mg/kg and the start of dosing in the new triplet cohort combining bexmarilimab with azacitidine and venetoclax.
“We continue to be encouraged by the promising early data observed in this trial, notably the patients who have already shown control of blast counts in blood and bone marrow,” said Marie-Louise Fjällskog, chief medical officer of Faron.
“These observations support the potential for synergy of bexmarilimab in combination with standard of care. In addition, patient recruitment has started in the first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients deemed unsuitable for conventional chemotherapy.”
This and other earlier data will be shared with the current BEXMAB study group and potential new U.S. study site investigators who will convene for the 64th American Society for Hematology (ASH) meeting in New Orleans, Louisiana from December 10-13, 2022.