Bio-Path Holdings, a clinical-stage biotechnology company focused on developing RNAi nanoparticle-based therapies for cancer, recently presented positive data from an ongoing Phase 2 combination study of their drug candidate, Prexigebersen, at the American Society of Clinical Oncology (ASCO) Annual Meeting. The results of an interim analysis demonstrated significant clinical improvement and a tolerable safety profile for the Prexigebersen combination in high-risk patients with acute myeloid leukemia (AML).
AML is a type of cancer that affects the bone marrow and blood. It is a rapidly progressing disease with a poor prognosis, particularly in high-risk patients who have genetic mutations associated with treatment resistance. Prexigebersen, an antisense oligonucleotide, is designed to target and inhibit the production of the Grb2 protein, which is known to play a critical role in the growth and survival of cancer cells.
The Phase 2 combination study aims to evaluate the efficacy and safety of Prexigebersen in combination with decitabine, a chemotherapy drug commonly used in the treatment of AML. The interim analysis included data from 17 patients who had completed at least one cycle of treatment.
The results showed that the Prexigebersen combination therapy led to a significant reduction in bone marrow blast cells, a key indicator of disease burden in AML. Additionally, three out of 17 patients achieved a complete remission, indicating the eradication of cancer cells. The combination therapy also showed a tolerable safety profile, with manageable adverse events reported.
Dr. Michael Redman, Chief Medical Officer of Bio-Path Holdings, expressed his excitement about the positive results, stating, The reduction in bone marrow blast cells and complete remissions seen in this study are encouraging signs of clinical activity and provide a strong rationale for further development of Prexigebersen in high-risk patients with AML.
In addition to Prexigebersen, Bio-Path Holdings is also developing another drug candidate called BP1002, which targets Bcl-2, a protein that promotes cancer cell survival in AML patients. BP1002 utilizes RNA interference (RNAi) technology to limit the production of Bcl-2 protein and offers a unique opportunity for patients who have become resistant to Venetoclax, a drug commonly used in AML treatment.
The company recently announced the successful completion of the first dose cohort in a Phase 1/1b clinical trial of BP1002 in refractory/relapsed AML patients. The results demonstrated the potential of BP1002 to effectively inhibit the production of Bcl-2 protein and provide a viable treatment option for Venetoclax-resistant patients.
In conclusion, Bio-Path Holdings is making significant progress in the development of RNAi nanoparticle-based therapies for the treatment of AML. The positive data presented from the ongoing Phase 2 combination study of Prexigebersen, along with the promising results of the Phase 1/1b clinical trial of BP1002, highlight the potential of these drug candidates to address the unmet needs of high-risk and resistant AML patients. Further development of these therapies could provide new hope for patients battling this aggressive form of leukemia.
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