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Bio-Path Holdings Provides Clinical and Operational Update
Globenewswire· 2025-06-03 11:00
Core Insights - Bio-Path Holdings, Inc. is advancing its proprietary DNAbilize platform to develop targeted nucleic acid drugs for cancer and obesity, with a focus on licensing opportunities for commercialization [1][2] Clinical Program Overview - The Phase 2 clinical trial for Prexigebersen in treating Acute Myeloid Leukemia (AML) includes three patient cohorts, with promising results showing two patients in complete remission after over 15 treatment cycles [3][4] - A Phase 1/1b trial for BP1001-A in advanced solid tumors is ongoing, with a patient showing a 15% reduction in tumor size after ten treatment cycles, indicating potential for improved quality of life [5][6] - The Phase 1/1b trial for BP1002 targets relapsed/refractory AML patients, with no dose-limiting toxicities observed in initial cohorts, reflecting a strong demand for new treatment options [7][8] Drug Development and Applications - BP1001-A has shown potential as a treatment for obesity in Type 2 diabetes patients by downregulating Grb2 expression, with preclinical studies confirming its efficacy [9] - The company plans to file an Investigational New Drug (IND) application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide [10] 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 [10][13]
Bio-Path (BPTH) Update / Briefing Transcript
2025-05-29 13:30
Bio-Path Holdings Conference Call Summary Company Overview - **Company**: Bio-Path Holdings (BPTH) - **Industry**: Biotechnology, focusing on DNA-powered medicine and therapeutics for oncology and obesity Key Points and Arguments 1. **Company Mission and Technology**: Bio-Path aims to usher in a new era of DNA-powered medicine, focusing on developing drug products from their platform technology and licensing them for commercialization [4][5] 2. **Investment Opportunity**: The company presents a strong investment opportunity due to the potential for high returns from licensing drug candidates, which can occur earlier than waiting for drug approvals [5] 3. **Pipeline Highlights**: - **Solid Tumor Treatment**: Potential for rapid clinical development [6] - **Relapsed AML Treatment**: Targeting patients with survival expectations of less than three months, with potential for Fast Track approval [6] - **Type 2 Diabetes and Obesity Treatment**: High return potential [6] 4. **DNAbilize Technology**: A patented method for producing antisense DNA therapeutics that overcomes traditional delivery challenges, allowing for high payload delivery without toxicity [7][8][9] 5. **Intellectual Property**: The company holds a robust patent portfolio with seven issued patents in the US and 61 in foreign jurisdictions, protecting their technology across 26 countries [10] 6. **Clinical Trials**: - **Prexigebersen**: Advancing in a Phase 2 trial for AML, with promising results from patients demonstrating treatment durability [11][12][13] - **BP1002**: Targeting Bcl-2 protein in refractory relapsed AML patients, with a focus on overcoming resistance mechanisms [14][15] - **BP1003**: Targeting STAT3 protein, with plans for an IND application to the FDA [19][20] - **BP1001 A**: A treatment for obesity and related metabolic diseases, with preclinical models showing promise in enhancing insulin sensitivity [21][22] 7. **Patient Outcomes**: Positive responses reported in clinical trials, including a patient with a 15% reduction in tumor size after treatment with BP1001 A [23][24] 8. **Market Resilience**: Despite recent market turbulence, the biotech sector remains innovative and presents growth opportunities [25] Additional Important Content - **Regulatory Pathway**: The company is preparing to file IND applications for BP1001 A in 2025 to initiate Phase 1 clinical trials [22] - **Patient Population**: The focus on vulnerable patient populations, particularly those with limited treatment options, highlights the company's commitment to addressing unmet medical needs [18][24] - **Future Outlook**: Bio-Path is well-positioned for continued success with a promising pipeline and expected meaningful news flow throughout the year [25]
Bio-Path Holdings to Host Corporate Update Conference Call on May 29, 2025
Globenewswire· 2025-05-22 20:30
Company Overview - Bio-Path Holdings, Inc. is a biotechnology company focused on developing targeted nucleic acid cancer and obesity drugs using its proprietary DNAbilize antisense RNAi nanoparticle technology [1][3] - The company has a pipeline of RNAi nanoparticle drugs that can be administered via intravenous infusion [3] Product Pipeline - The lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers [3] - BP1001-A, a modified version of prexigebersen, is in a Phase 1/1b study for solid tumors and is also being evaluated for obesity and related metabolic diseases in Type 2 diabetes patients [3] - The second product, BP1002, targets the Bcl-2 protein and is being evaluated for blood cancers and solid tumors, including acute myeloid leukemia [3] - An IND application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, is expected to be filed [3] Upcoming Events - The company will host a live conference call and audio webcast on May 29, 2025, at 8:30 a.m. ET to provide a comprehensive business overview [1]
Bio-Path(BPTH) - Prospectus
2023-12-22 21:05
As filed with the Securities and Exchange Commission on December 22, 2023 TABLE OF CONTENTS BIO-PATH HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) 4710 Bellaire Boulevard, Suite 210 Bellaire, Texas 77401 (832) 742-1357 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE ...
Bio-Path(BPTH) - Prospectus(update)
2023-08-01 11:50
TABLE OF CONTENTS FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIO-PATH HOLDINGS, INC. (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on August 1, 2023 Registration No. 333-272879 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 To 2834 (Primary Standard Industrial Classification Code Number) 4710 Bellaire Boulevard, Suite 210 Bellaire, Texas 77401 (832) 742-1357 (Address, including zip co ...
Bio-Path(BPTH) - Prospectus
2023-06-23 20:16
As filed with the Securities and Exchange Commission on June 23, 2023 Registration No. 333- TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIO-PATH HOLDINGS, INC. (Exact name of registrant as specified in its charter) 2834 (Primary Standard Industrial Classification Code Number) 4710 Bellaire Boulevard, Suite 210 Bellaire, Texas 77401 (832) 742-1357 (Address, including zip code, and telephone number, ...
Bio-Path(BPTH) - Prospectus(update)
2023-02-03 21:14
TABLE OF CONTENTS As filed with the Securities and Exchange Commission on February 3, 2023 Registration No. 333-269045 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIO-PATH HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (Name, address, including zip code, an ...