Bio-Path Holdings Unveils Phase 2 Prexigebersen Data for AML at ASCO Annual Meeting
Bio-Path Holdings, Inc., a biotechnology firm specializing in nucleic acid cancer drugs, has presented encouraging interim results from its Phase 2 clinical trial of prexigebersen (BP1001) at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study evaluates prexigebersen combined with decitabine and venetoclax for treating acute myeloid leukemia (AML).
Presentation at ASCO
Dr. Maro Ohanian from the University of Texas MD Anderson Cancer Center shared the data, highlighting significant clinical improvements and a tolerable safety profile for prexigebersen. The results were compelling for both newly diagnosed and refractory/relapsed AML patients, outperforming standard frontline therapies.
Cohort 1: Newly Diagnosed AML Patients
In the first cohort, 31 newly diagnosed AML patients were enrolled, with 20 patients being evaluable. These patients had a median age of 75 years and were treated with at least one cycle of the drug combination. Among these, 15 patients (75% of the evaluable group) achieved complete remission (CR), CRh (partial recovery of peripheral blood counts), or CRi (incomplete hematologic recovery). Additionally, two patients achieved partial remission (PR), and two others reached stable disease (SD).
Cohort 2: Refractory/Relapsed AML Patients
The second cohort included 38 patients with relapsed or refractory AML, with 23 being evaluable. These patients had a median age of 63 years. Out of these, 12 patients (55% of the evaluable group) achieved CR/CRh/CRi, one patient achieved PR, eight patients had SD, and one patient experienced treatment failure.
Safety and Adverse Events
The adverse events observed in both cohorts were consistent with those expected with decitabine and venetoclax treatment, as well as AML itself. Common side effects included fatigue (72%), anemia (60%), and neutropenia (49%). The most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%).
Future Directions
Buoyed by these promising interim results, Bio-Path Holdings plans to continue enrolling patients, with an aim to include up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.
About Bio-Path Holdings
Bio-Path Holdings is advancing DNAbilize®, a unique liposomal delivery and antisense technology platform. The company’s leading product, prexigebersen, targets the Grb2 protein and is undergoing Phase 2 trials for blood cancers. Another variant, BP1001-A, is in early-phase trials for solid tumors. Bio-Path's second product, BP1002, targets the Bcl-2 protein and is being tested for various cancers, including AML and lymphoma. An IND for BP1003, which targets the STAT3 protein, is also anticipated.
Conclusion
These interim findings underscore prexigebersen's potential to offer a significant clinical benefit for high-risk AML patients, who often have limited treatment options. The ongoing trial aims to validate these preliminary results through further patient enrollment and continued evaluation.
The data presented at ASCO highlights both the efficacy and safety of prexigebersen in combination with decitabine and venetoclax, marking a hopeful advancement in the treatment of AML.
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