Bio-Path Holdings Provides 2025 Clinical and Operational Update

Core Viewpoint - Bio-Path Holdings, Inc. is advancing multiple clinical programs targeting significant unmet medical needs in oncology and obesity, with several milestones expected in 2025, including the development of new applications for existing drugs and the introduction of novel therapies [1]. Clinical Development Overview - The clinical development program includes one Phase 2 trial for acute myeloid leukemia (AML), two Phase 1 or 1/1b trials, and two preclinical programs [2]. - A molecular biomarker package has been developed for the Phase 2 AML trial to identify patients likely to respond to prexigebersen treatment, with plans to utilize this in 2025 [2]. Prexigebersen Phase 2 Clinical Trial - The Phase 2 trial consists of three patient cohorts, each targeting different AML patient groups, with the first two cohorts using a combination of prexigebersen, decitabine, and venetoclax [3]. - The trial aims to improve outcomes for older patients with a median survival of only 5 to 10 months who cannot receive intensive chemotherapy [3]. BP1001-A Phase 1/1b Clinical Trial - A Phase 1/1b trial for BP1001-A in advanced solid tumors is ongoing, showing promising results in a patient with gynecologic cancer, including a 15% reduction in tumor size after nine treatment cycles [4]. - The study is expected to progress to Phase 1b, assessing BP1001-A in combination with paclitaxel and gemcitabine for various cancers [5]. BP1002 Phase 1/1b Clinical Trial - The Phase 1/1b trial for BP1002 targets relapsed/refractory AML patients, including those resistant to venetoclax, with promising early results and no dose-limiting toxicities observed [6]. BP1001-A for Obesity in Type 2 Diabetes - BP1001-A is being explored as a treatment for obesity in Type 2 diabetes patients, with preclinical studies confirming its potential to lower blood glucose levels by downregulating Grb2 expression [7]. - An Investigational New Drug (IND) application for BP1001-A is expected to be filed later in 2025 [7]. Intellectual Property Protection - Bio-Path holds a robust patent portfolio, including composition of matter patents that protect its proprietary products and allow for the application of its technology to new protein targets [8][11].