Bio-Path Holdings, Inc. (NASDAQ:BPTH) has broadened the application of its DNAbilize® antisense RNAi nanoparticle technology beyond oncology with the initiation of a therapeutic program targeting obesity. The company also reported advancements in its oncology programs, including the swift enrollment of a Phase 1/1b clinical trial cohort for acute myeloid leukemia (AML) and the publication of preclinical data on BP1003's anti-tumor effects.
Expansion into Obesity with BP1001-A
Bio-Path's new program will develop BP1001-A for the treatment of obesity and related metabolic diseases. This marks the first application of the DNAbilize® technology outside of cancer. The rationale behind this expansion lies in BP1001-A's mechanism of action: it suppresses the adaptor protein Grb2, which is implicated in insulin resistance, a key factor in obesity, type 2 diabetes, and other metabolic disorders. The company anticipates that downregulating Grb2 expression will enhance insulin sensitivity.
Advancing BP1002 in Venetoclax-Resistant AML
Bio-Path has completed enrollment for the third dosing cohort of its Phase 1/1b clinical trial of BP1002 in patients with venetoclax-resistant AML. The rapid enrollment underscores the unmet need for new treatment options in this patient population. BP1002 targets the Bcl-2 protein, which is crucial for cancer cell survival.
Preclinical Data on BP1003's Broad Anti-Tumor Effect
An article published in the peer-reviewed journal Biomedicines highlighted the therapeutic potential of BP1003 in various cancer types. The study demonstrated a broad anti-tumor effect of BP1003 in preclinical solid tumor models, including breast, ovarian, and pancreatic cancer. BP1003 is a liposome-incorporated STAT3 antisense oligodeoxynucleotide, designed for enhanced stability, cellular uptake, and target affinity.
Positive Patient Response in Solid Tumor Trial
Bio-Path reported a positive response in the first patient in the second dose cohort of its Phase 1/1b advanced solid tumor clinical trial. The patient, who had failed extensive chemotherapy and surgical treatment for gynecologic cancer, experienced a 15% reduction in her primary tumor after six cycles of treatment with BP1001-A. This outcome suggests that BP1001-A has potential as a new treatment for advanced solid tumors and contributed to improved quality of life.
The Phase 1/1b trial is evaluating BP1001-A monotherapy in patients with advanced or recurrent solid tumors. The trial has completed the initial dose cohort of 60 mg/m2 and has begun enrollment in the higher dose cohort of 90 mg/m2. A Phase 1b portion of the study is planned to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer.
Financial Update
Bio-Path reported a net loss of $2.1 million, or $0.70 per share, for the three months ended September 30, 2024, compared to a net loss of $3.2 million, or $6.36 per share, for the three months ended September 30, 2023. As of September 30, 2024, the Company had cash of $0.6 million, compared to $1.1 million as of December 31, 2023.
