Bio-Path presents data from ongoing Phase 2 combination study of prexigebersen

Bio-Path Holdings presented interim results from the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia in an oral presentation at the American Society of Clinical Oncology Annual Meeting, on June 1, 2024 in Chicago, IL. Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has demonstrated compelling efficacy results in two reporting cohorts including newly diagnosed AML patients and refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients with a median age of 75 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML evolved from myelodysplastic syndromes, chronic myelomonocytic leukemia or treatment-related AML. Fifteen patients achieved complete remission, CRh, or CRi; two patients achieved partial remission and two patients achieved stable disease. In Cohort 2, 38 relapsed/refractory patients were enrolled; 23 evaluable patients with a median age of 63 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or sAM. Twelve patients achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure. Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue, anemia and neutropenia, while the most frequent severe adverse events were febrile neutropenia and sepsis. Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.