Bio-Path Holdings Shares Clinical Update and Expansion Plans

Bio-Path Holdings, Inc., a biotechnology company listed on NASDAQ under the ticker BPTH, is making significant strides in its clinical research programs targeting various cancer types. Utilizing its proprietary DNAbilize® liposomal delivery and antisense technology, the company is expanding its portfolio to include potential treatments beyond oncology, including obesity.

Peter H. Nielsen, President and CEO of Bio-Path, highlighted the company's progress, noting advancements in clinical data and the development of necessary biomarkers for oncology studies. These developments are pivotal for the ongoing and future clinical trials. Furthermore, Bio-Path has completed preparations for preclinical studies aimed at exploring prexigebersen as a potential treatment for obesity, marking an expansion of their research into a new therapeutic area.

Bio-Path's clinical program includes one Phase 2 trial and three Phase 1 or 1/1b trials. A critical component of their strategy involves the development of a molecular biomarker package to improve patient selection and treatment efficacy. This approach is increasingly common in oncology, where biomarkers play a vital role in identifying patients who are more likely to respond to specific treatments.

The Phase 2 clinical trial of prexigebersen targets Acute Myeloid Leukemia (AML) patients and consists of three cohorts. The first two cohorts involve a triple combination of prexigebersen, decitabine, and venetoclax, treating both untreated and relapsed/refractory AML patients. The third cohort focuses on relapsed/refractory AML patients resistant or intolerant to venetoclax, using a combination of prexigebersen and decitabine. Interim data on safety and efficacy suggest promising results, and Bio-Path plans to incorporate molecular biomarkers in future patient selection to enhance trial outcomes. The study is currently paused for interim analysis, with enrollment completion expected over the next 18 months.

In addition, Bio-Path is conducting a Phase 1/1b trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian, uterine, pancreatic, and breast cancers. BP1001-A is a modified version of prexigebersen designed to improve nanoparticle properties. The trial has progressed to the second dose level, with the Phase 1b portion set to evaluate BP1001-A in combination with paclitaxel and gemcitabine for ovarian and pancreatic cancers, respectively. Enrollment for dose level 3 is anticipated by the end of the year.

Another key trial involves BP1002, which targets the Bcl-2 protein responsible for cell survival in many cancers. This Phase 1/1b trial addresses relapsed/refractory AML patients, including those resistant to venetoclax. The first dose cohort showed no dose-limiting toxicities, and the second cohort of 40 mg/m2 is under analysis. Bio-Path expects to advance to the next dose level after FDA review.

Bio-Path is also investigating BP1002 for treating refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL). This Phase 1 trial involves multiple sites and has successfully completed its first dose cohort without dose-limiting toxicities. Enrollment for the second dose cohort is ongoing, with data review expected by year-end.

The company is advancing BP1003, an antisense RNAi nanoparticle targeting the STAT3 protein, for treating advanced solid tumors, including pancreatic cancer. Plans include a Phase 1 study for patients with refractory, metastatic solid tumors.

Prexigebersen's potential extends to obesity and related cancers by targeting the Grb2 protein, which plays a role in cell growth pathways activated by leptin and insulin. Leveraging extensive safety data from leukemia treatments, Bio-Path is preparing preclinical developments and Investigational New Drug (IND) studies for this indication, aiming to initiate first-in-human studies.

Bio-Path Holdings, Inc. remains dedicated to pioneering RNAi nanoparticle drugs through its DNAbilize® platform, with ongoing trials for blood cancers and solid tumors. The company continues to pursue innovative treatments that could address significant unmet medical needs across various indications.

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