Faron Announces New Biomarker Data from Phase I/II BEXMAB Study at EHA2023 Hybrid Congress
- Bexmarilimab mode of action in AML/MDS supported with durable Clever-1 target engagement in bone marrow, with increases observed in T and NK cells and antigen presentation
- Clinical activity across indications, with objective responses in 5 of 10 patients
- Dose escalation ongoing, with initiation in 2H 2023 of Phase II in relapsed/refractory AML and MDS after failure on hypomethylating agents
Faron Pharmaceuticals Oy (AIM: FARN) (First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces the release of new biomarker data from the ongoing Phase I/II BEXMAB study of bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The data will feature in a poster presentation at the European Hematology Association (EHA) 2023 Hybrid Congress on June 9, 2023.
In BEXMAB patients, a high Clever-1 expression in leukemic blasts is associated with lower levels of antigen presentation. The proposed mode of action of bexmarilimab in AML/MDS is now supported by the biomarker data, which suggests durable Clever-1 target engagement in the bone marrow tumor microenvironment with increases observed in key cell types limiting cancer growth and spread, namely T and NK cells (up to 2-3-fold). In addition, bexmarilimab treatment increased HLA-DR expression by leukemic blasts, indicating improved immune recognition and eradication of the malignant cells.
The poster also updates preliminary efficacy data, previously communicated by the Company in January and April 2023, showing objective responses in 5 out of 10 patients across the first and second dose cohorts of the study (1 or 3mg/kg bexmarilimab + azacitidine), as observed by a reduction in bone marrow blasts, leading to complete and partial remissions. The initial data also shows that bexmarilimab treatment is well-tolerated without adding toxicity to standard azacitidine therapy.
“The BEXMAB study continues to generate data that are an excellent indication of the therapeutic potential of bexmarilimab to change the treatment paradigm for patients with hematological malignancies,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron Pharmaceuticals. “We are encouraged by the results and look forward to progressing the BEXMAB program.”
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