BP1003 / Bio-Path - LARVOL DELTA

Bio-Path Holdings Announces Publication in Biomedicines (GlobeNewswire) - "Bio-Path Holdings, Inc...announced a publication highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal, Biomedicines. The article...describes the broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models including breast, ovarian, and pancreatic cancer."

Preclinical • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

BP1003 Decreases STAT3 Expression and Its Pro-Tumorigenic Functions in Solid Tumors and the Tumor Microenvironment. (PubMed, Biomedicines) - "BP1003 efficiently reduces STAT3 expression and enhances the sensitivity of breast cancer cells (HER2+, triple negative) and ovarian cancer cells (late stage, invasive ovarian cancer) to paclitaxel and 5-fluorouracil (5-FU) in both 2D and 3D cell cultures. Similarly, ex vivo and in vivo patient-derived models of pancreatic ductal adenocarcinoma (PDAC) show reduced tissue viability and tumor volume with BP1003 and gemcitabine combination treatments...Unlike M1 differentiation, monocyte differentiation into anti-inflammatory M2 macrophages is suppressed by BP1003, indicating its potential contribution to immunotherapy. The broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models, such as breast, ovarian, and pancreatic cancer models shown in this work, makes it a promising cancer therapeutic."

Biomarker • IO biomarker • Journal • Tumor microenvironment • Breast Cancer • Gastrointestinal Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2 • STAT3

Bio-Path Holdings Provides 2024 Clinical and Operational Update (GlobeNewswire) - "Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL)...Enrollment is now open for patients for the second BP1002 dose cohort of 40 mg/m2....Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer)."

Enrollment status • New P1 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Bio-Path Holdings Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "We look forward to initiating our Phase 1 study of BP1001-A for the treatment of solid tumors later this year and to filing an Investigational New Drug (IND) application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, in the first half of 2023."

IND • Trial status • Oncology • Solid Tumor

Targeting STAT3 with novel liposome-incorporated antisense oligonucleotide technology enhances the efficacy of paclitaxel (taxol) and 5-fluorouracil (5-FU) in breast and ovarian cancer cells (AACR 2022) - "Background: STAT3 is a transcription factor that regulates various tumorigenic processes, such as tumor proliferation, metastasis, and drug resistance. BP1003 efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol and 5-FU. These results are in line with previous work in which BP1003 + gemcitabine displayed enhanced anti-tumor activity in pancreatic ductal adenocarcinoma. Together these results strongly suggest that BP1003 combination therapy is a novel strategy for patients with advanced solid tumors."

Clinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • FGFR1 • STAT3

Bio-Path Holdings Presents BP1003 Data at 2022 American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Bio-Path Holdings...presented a poster highlighting preclinical BP1003 data at the 2022 American Association for Cancer Research (AACR) Annual Meeting....Preclinical data support BP1003 combination therapy to treat breast and ovarian cancers....'The data show that BP1003 enhances the efficacy of current standard of care chemotherapies in these difficult to treat solid tumor cancers'....'We look forward to filing an Investigational New Drug (IND) application for BP1003 and to initiating a clinical study in patients with advanced solid tumors'."

IND • New trial • Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Bio-Path Holdings to Present at the 2022 American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Bio-Path Holdings...announced an upcoming poster presentation at the 2022 American Association for Cancer Research (AACR) Annual Meeting, taking place in Atlanta, GA on April 8-13, 2022...Bio-Path Holdings, will discuss pre-clinical studies of BP1003 (liposomal STAT3 antisense) in combination with paclitaxel or fluorouracil as a potential treatment against breast and ovarian cancer cells."

Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Bio-Path Granted Key Mechanism of Action U.S. Patent for BP1003 (GlobeNewswire) - “Bio-Path Holdings, Inc…announced that the United States Patent and Trademark Office has granted a new patent relating to the Company’s BP1003 program, a novel liposome-incorporated oligodeoxynucleotide inhibitor against Signal Transduction and Activator of Transcription-3 (STAT3). The patent (U.S. Patent No. 11,041,153) is titled ‘P-Ethoxy Nucleic Acids for STAT3 Inhibition’…'This mechanistic patent protects our position and underscores the novelty of BP1003’s ability to inhibit STAT3, a protein known to be overly expressed in a number of the most difficult to treat cancers such as pancreatic cancer (PDAC), non-small cell lung cancer (NSLCL) and acute myeloid leukemia (AML), among others. We are looking forward to advancing BP1003’s development in pancreatic cancer, which we expect to begin next year.’”

New trial • Patent • Acute Myelogenous Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer

"$BPTH Bio-Path Granted Key Mechanism of Action U.S. Patent for BP1003 https://t.co/EALmBZ5bp9 #patent" (@stock_titan)

[VIRTUAL] Bio-Path Holdings Inc. (BIO 2020) - "Following the successful completion of the safety testing in Stage 2 of a Phase 2 Clinical Trial of prexigebersen in Acute Myeloid Leukemia (AML), Bio-Path is advancing this program to its next stage in the first half of 2020. Bio-Path is initiating a Phase 1 study of its 2nd pipeline candidate, BP1002 (liposomal Bcl-2), in the 1st half of 2020 to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients. And BioPath is nearing completion of IND-enabling studies of BP1003, a novel liposome- incorporated STAT3."

Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Endometrial Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • BCL2 • STAT3

Bio-Path Holdings reports full year 2019 financial results (GlobeNewswire) - “Following the successful completion of the safety testing in Stage 2 of our Phase 2 Clinical Trial of prexigebersen in Acute Myeloid Leukemia (AML), we now plan to advance this program to its next stage in the first half of 2020. In addition, we filed an Investigational New Drug (IND) application for prexigebersen in the treatment of solid tumors including ovarian and endometrial cancer and expect to start that study later this year. ’We also are in the process of initiating a Phase 1 study of our second pipeline candidate, BP1002 (liposomal Bcl-2), in the first half of this year to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients...expect to file an IND application for a Phase 1 study of BP1003 for the treatment of solid tumors, including pancreatic cancer, in 2020...'"

IND • New P1 trial • New trial • Trial status

Bio-Path holdings provides clinical update and 2020 business outlook (GlobeNewswire) - “Phase 1 Study of BP1002 in Refractory or Relapsed Lymphoma Patients and Chronic Lymphocytic Leukemia Patients: This study is expected to commence in the first half of 2020 and is expected to be conducted at several premier oncology centers, including the University of Texas MD Anderson Cancer Center, and is planned to evaluate the safety of BP1002 in several dose escalating cohorts to determine a maximum tolerated dose…. In 2020 Bio-Path expects to complete several IND-enabling studies for BP1003. If those studies are successful, Bio-Path expects that it would file an IND in late 2020 for the first-in-humans Phase 1 study of BP1003 in patients with refractory/metastatic solid tumors including pancreatic, non-small cell lung cancer, and colorectal cancers.”

IND • Trial initiation date

Bio-Path Holdings Reports Second Quarter 2019 Financial Results (GlobeNewswire, Bio-Path Holdings, Inc.) - We are excited to begin dosing patients in the amended cohorts of our Phase 2 study of prexigebersen, which will first evaluate the safety of prexigebersen in combination with decitabine in untreated AML and high risk MDS patients and refractory/relapsed AML and high risk MDS patients, and then evaluate the efficacy of the triple combination of prexigebersen + decitabine + venetoclax in those patient groups,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. . “We are also looking forward to completing Investigational New Drug (IND) enabling studies of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor for the treatment of pancreatic cancer, and to file an IND application for a Phase 1 study of BP1003 for the treatment of pancreatic cancer in 2020. In April 2019, Bio-Path presented data from preclinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the...

Commercial • Enrollment status • Preclinical • Regulatory