Bio-Path Holdings Reports Strong Response to BP1001-A in Solid Tumor Patients

Bio-Path Holdings, Inc., a biotechnology firm listed on NASDAQ (BPTH), has recently delivered updates on its ongoing clinical trials, demonstrating promising advancements in their treatments for both solid tumors and Acute Myeloid Leukemia (AML). The company utilizes its proprietary DNAbilize® platform, a cutting-edge liposomal delivery and antisense technology, to develop targeted nucleic acid cancer therapies.

A notable development has emerged from Bio-Path’s Phase 1/1b clinical trial of BP1001-A, which involves patients with advanced solid tumors. The first patient treated with a higher dose of 90 mg/m2 showed significant tumor reduction and maintained stable disease status. This patient, an elderly female with gynecologic cancer, had previously undergone multiple lines of chemotherapy and surgeries without favorable results. The current treatment has led to a 15% reduction in her primary tumor over six cycles and has notably improved her quality of life, enabling her to engage in rigorous exercise without the severe side effects commonly associated with conventional treatments.

The Phase 1/1b trial focuses on BP1001-A as a monotherapy, initially at a dose of 60 mg/m2, and has now moved to the higher dose cohort of 90 mg/m2. After completing three planned dose levels, the trial will advance to Phase 1b to assess the safety and efficacy of BP1001-A combined with paclitaxel for recurrent ovarian or endometrial tumors. Further studies are anticipated in combination with gemcitabine for late-stage pancreatic cancer.

In addition to the solid tumor trial, Bio-Path is also making headway in its Phase 2 study of prexigebersen in AML. Two elderly patients in this trial have shown extended treatment durability. One female patient has received 16 cycles over 21 months and remains in complete remission, while a male patient has completed his twelfth cycle over fourteen months, also maintaining complete remission. Both patients have responded well to the triple combination treatment of prexigebersen, decitabine, and venetoclax, showcasing the potential of this regimen to treat fragile AML patients who typically cannot endure intensive chemotherapy.

Bio-Path’s DNAbilize platform is designed to achieve systemic delivery for target-specific protein inhibition of over-expressed disease-causing genes. The technology incorporates a DNA backbone modification known as P-ethoxy, which safeguards the DNA from enzymatic degradation in the body, into a neutral lipid bilayer structure. This innovative approach allows for high-efficiency delivery of antisense DNA into cells, facilitating the reduction or elimination of target proteins in blood diseases and solid tumors. The platform has demonstrated a promising safety and efficacy profile through various animal studies and clinical trials.

Bio-Path’s lead candidate, prexigebersen (BP1001), targets the Grb2 protein and is currently in a Phase 2 study for blood cancers. BP1001-A, a variant of prexigebersen, is in Phase 1/1b trials for solid tumors. Another promising candidate, BP1002, targets the Bcl-2 protein and is under evaluation for blood cancers and solid tumors, including lymphoma and AML. Furthermore, an Investigational New Drug (IND) application is expected for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide.

The advancements in Bio-Path’s clinical trials underscore the potential of the DNAbilize platform to treat some of the most challenging cancer cases, offering hope for patients who have exhausted traditional treatment options.