BP1002 (Liposomal Bcl-2) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Lymphoma can start anywhere in the body where lymph tissue is found. The major sites of lymph tissue are: lymph nodes, bone marrow, spleen, thymus, adenoids & tonsils, digestive tract. Non-Hodgkin’s lymphoma (NHL) is a term used for many different types of lymphoma that share some common characteristics. In the U.S., approximately 77,240 new cases and 19,940 deaths from NHL were expected in 2020. Approximately 40% of NHLs are indolent lymphomas and approximately 60% are the more aggressive lymphomas. Indolent lymphomas grow and spread slowly. Some indolent lymphomas might not need to be treated right away but can be watched closely instead. On the other hand, aggressive lymphomas usually need to be treated right away as they grow and can spread quickly to other parts of the lymph system or to other parts of the body, such as the liver, brain, or bone marrow.
BP1002 (Liposomal Bcl-2) is a neutral-charge, liposome-incorporated antisense drug designed to inhibit protein synthesis of Bcl-2, a protein involved in blocking programmed cell death. Bcl-2 is overexpressed in a wide variety of tumors, including NHL and chronic lymphocytic leukemia. Overexpression of Bcl-2 stops affected cells from being killed by chemotherapy. We believe that BP1002 will inhibit Bcl-2 protein expression without inherent toxicity. The introduction of a new, non-toxic, and specific Bcl-2 inhibitor could be a major advance in cancer therapeutics.
A Phase 1 clinical trial for BP1002 in patients with relapsed or refractory NHL or chronic lymphocytic leukemia is currently underway.
BP1002 (Liposomal Bcl-2) for AML patients relapsed from Bcl-2 inhibitor treatment
The Bcl-2 inhibitor venetoclax is used in frontline combination therapies for elderly patients with acute myeloid leukemia (AML); however, venetoclax resistance had been observed. A recent study found that AML patients who had relapsed from frontline venetoclax-based treatment had a very poor prognosis, with a median survival of less than 3 months. Since venetoclax and BP1002 utilize different mechanisms of action, we believe BP1002 may be a potential treatment for venetoclax-relapsed AML patients. Preclinical studies suggest that the combination of BP1002 with decitabine is efficacious in venetoclax-resistant cells. A Phase 1/1b study of BP1002 in combination with decitabine in AML patients who have relapsed from venetoclax-based treatment is ongoing.
Bio-Path is currently conducting two clinical studies on BP1002
A Phase 1 clinical trial of BP1002 in patients with advanced lymphoid malignancies is ongoing. The safety and efficacy of BP1002 will be investigated in patients with relapsed or refractory NHL or chronic lymphocytic leukemia. More details for this study may be found on: https://clinicaltrials.gov/ct2/show/NCT04072458.
A Phase 1 Clinical Trial of BP1002 in Patients with Refractory/Relapsed Acute Myeloid Leukemia (AML), including those who have relapsed from venetoclax-based treatment, is underway. The study will evaluate the safety and efficacy of BP1002 as a monotherapy in patients with relapsed or refractory AML, followed by BP1002 in combination with decitabine. More details for this study may be found on: https://clinicaltrials.gov/ct2/show/NCT05190471.