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BEXMAB study update
BEXMAB study update.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n\nFaron Pharmaceuticals Ltd.\n (\"Faron\" or \"the Company\")\n \n Inside Information: Faron Updates Positive Clinical Data from Phase I/II BEXMAB Study of Bexmarilimab in Relapsed/Refractory AML and MDS\nBEXMAB Study Update\n \n· Three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved objective responses (CR and mCR)\n· Eight of 15 objective responses observed in all three doublet dosing cohorts\n· One patient has stayed on treatment for 13 months\n· Updated BEXMAB data supports advancement to Phase II in H2 2023 focusing on SoC relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA)\n· Filing of first Biologics License Application (BLA) to FDA planned for H1 2025\n· Company management team will host a conference call and webcast to discuss the data today at 8:30 am ET\n \nCompany Announcement, July 19, 2023\n \nInside Information\n \nTURKU, Finland / BOSTON, Massachusetts - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces new positive clinical data from the Company's ongoing Phase I/II BEXMAB study.\n \nThe BEXMAB study (ClinicalTrials.gov: NCT05428969) investigates bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with standard of care (SoC) in the aggressive hematological malignancies of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The data reported here builds on earlier positive results presented on June 9, 2023 at the European Hematology Association (EHA) 2023 Hybrid Congress.\n \nBEXMAB Phase I Study Update:\n \n· Three of five patients in 6 mg/kg bexmarilimab + azacitidine doublet dosing cohort showed an objective response (OR) of complete remission of blasts in the bone marrow (mCR).\n· In the three out of five patients in the 6 mg/kg + azacitidine doublet cohort, one patient also achieved a complete recovery of blood counts (CR).\n· Eight of 15 ORs were observed across all three doublet dosing cohorts.\n· Four of the eight patients across the thr...