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Bio-Path Holdings Inc. (NASDAQ: BPTH) is a pioneering biotechnology company focused on developing innovative therapeutic products through its proprietary DNAbilize® technology. This technology enables the delivery of nucleic acid drugs throughout the human body via simple intravenous infusion. Bio-Path's primary focus is on oncology, aiming to provide effective treatments for various forms of cancer.
The company's lead product candidate, prexigebersen (BP1001), is currently in Phase II clinical trials for Acute Myeloid Leukemia (AML) in combination with low-dose cytarabine (LDAC) and decitabine. Additionally, Bio-Path is exploring prexigebersen's potential in combination with dasatinib for patients with blast-phase and accelerated-phase Chronic Myeloid Leukemia (CML).
Another key candidate, BP1002, targets the Bcl-2 protein, which plays a crucial role in cell survival for many cancers. BP1002 is being evaluated for its effectiveness against lymphoma and solid tumors, offering hope for venetoclax-resistant AML patients. The company's technological advantage lies in its DNAbilize® platform, a liposomal antisense DNA method that significantly improves oligonucleotide therapeutics' delivery and efficacy.
Bio-Path Holdings continues to expand its pipeline with additional candidates such as BP1003, a STAT3 antisense oligodeoxynucleotide, and BP1001-A, a modification designed for solid tumors. These developments emphasize the company's commitment to addressing unmet medical needs in oncology.
Recently, Bio-Path has made significant strides in its clinical programs, receiving positive feedback from the U.S. FDA and advancing its trials at renowned institutions including Weill Cornell Medical College and The University of Texas MD Anderson Cancer Center. The company maintains a robust intellectual property portfolio to protect its innovative DNAbilize® platform.
For investors and stakeholders, Bio-Path Holdings represents a forward-thinking entity with a strategic focus on developing novel RNAi nanoparticle drugs. The company's advancements in the clinical and preclinical stages underline its potential to make substantial contributions to cancer treatment paradigms.
Bio-Path Holdings (NASDAQ:BPTH) has expanded its global patent portfolio with new patents in the United States and New Zealand. The company received Notice of Allowance for U.S. Patent No. 17/339,366 for STAT3 inhibition and New Zealand Patent No. 741793 for liposomal formulation, both related to their DNAbilize® platform technology.
The company's current intellectual property portfolio includes seven issued patents in the U.S. and 61 issued patents in foreign jurisdictions, providing protection in 26 countries. Bio-Path has three pending patent applications in the U.S. and five additional allowed patent applications in foreign jurisdictions.
Bio-Path is developing RNAi nanoparticle drugs, with their lead candidate prexigebersen in Phase 2 for blood cancers, BP1001-A in Phase 1/1b for solid tumors, and BP1002 being evaluated for blood cancers and solid tumors. The company is also preparing an IND application for BP1003, a STAT3 inhibitor.
Bio-Path Holdings (NASDAQ:BPTH) has reported positive updates from two ongoing clinical trials. In the Phase 1/1b BP1001-A solid tumor trial, the first patient treated with the higher dose (90 mg/m2) showed a 15% tumor reduction and maintained stable disease through ten treatment cycles. This elderly female patient with gynecologic cancer had previously failed multiple chemotherapy treatments and surgeries.
In the Phase 2 trial of prexigebersen triple combination therapy for Acute Myeloid Leukemia (AML), two elderly patients have maintained complete remission. The first patient has received 20 cycles over 26 months, while the second has completed 16 cycles over 20 months. The therapy combines prexigebersen with decitabine and venetoclax.
The company's DNAbilize® platform technology demonstrates potential for developing multiple drug candidates for target-specific protein inhibition. The Phase 1b portion will assess BP1001-A's safety and efficacy in combination with paclitaxel for ovarian or endometrial tumors, with additional studies planned for pancreatic cancer treatment.
Bio-Path Holdings (NASDAQ:BPTH) has announced progress in its Phase 1/1b clinical trial of BP1002 for treating refractory/relapsed acute myeloid leukemia (AML). The trial has advanced to the fourth dose cohort of 90 mg/m2, with promising results from the third cohort where a patient showed stable disease and significant blast count reduction after one treatment cycle.
The study targets AML patients, including those resistant to venetoclax, the current standard of care. Notably, venetoclax-resistant patients typically have a median survival of less than 3 months. BP1002's unique approach targets Bcl-2 at the mRNA level, potentially overcoming venetoclax resistance mechanisms.
The trial is being conducted at major U.S. cancer centers, including Cornell University, MD Anderson Cancer Center, Scripps Health, and UCLA Cancer Center. The treatment protocol involves eight doses over 28 days, with plans to commence a combination therapy phase with decitabine after completing the monotherapy cohorts.
Bio-Path Holdings (NASDAQ:BPTH) has provided its 2025 clinical development and operational update, highlighting progress across multiple programs. The company is advancing its DNAbilize® platform in both oncology and a new application for obesity treatment in Type 2 Diabetes patients.
Key developments include: a Phase 2 clinical trial for prexigebersen in acute myeloid leukemia (AML) with three cohorts; an ongoing Phase 1/1b trial of BP1001-A for advanced solid tumors showing positive early results; and a Phase 1/1b trial of BP1002 for relapsed/refractory AML. The company has developed a molecular biomarker package to identify patients more likely to respond to prexigebersen treatment.
Notable progress includes a patient in the BP1001-A solid tumor trial showing a 15% tumor reduction after nine treatment cycles. The company plans to file an IND application for BP1001-A in obesity treatment for Type 2 Diabetes patients later in 2025.
Bio-Path Holdings (NASDAQ:BPTH) reported positive preclinical study results for BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The studies demonstrated that BP1001-A enhances insulin sensitivity by downregulating Grb2 protein expression, which helps lower blood glucose levels.
Key findings showed that BP1001-A reduced Grb2 protein expression in myoblast cells and increased phosphorylated AKT and FOXO-1 levels in myoblast and hepatoma cells with insulin present. The company has initiated animal studies and plans to begin a first-in-human Phase 1 clinical trial in 2025 to validate safety, measure pharmacokinetics, and establish dosing for potential pivotal trials.
Stonegate Capital Partners has updated its coverage on Bio-Path Holdings (NASDAQ: BPTH) for the third quarter of 2024. The detailed announcement includes downloadable images, bios, and more information. For the complete announcement, click the image above.
Bio-Path Holdings (NASDAQ:BPTH) has outlined its strategic focus on developing BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The company's decision is based on scientific evidence suggesting that downregulating growth factor receptor-bound protein 2 (Grb2) could help lower blood glucose levels by affecting insulin signaling.
The company is conducting confirmatory preclinical studies and plans to complete IND-enabling testing in Q4 2024. Simultaneously, Bio-Path announced the discontinuation of its Phase 1 clinical trial of BP1002 for refractory/relapsed lymphoma and chronic lymphocytic leukemia due to enrollment challenges in these niche indications.
Bio-Path Holdings reported Q3 2024 financial results with a net loss of $2.1 million ($0.70 per share), compared to $3.2 million loss in Q3 2023. The company initiated a new obesity program using its DNAbilize® technology, marking its first non-oncology application. Research and development expenses decreased to $1.3 million from $2.3 million year-over-year. The company completed enrollment for the third dosing cohort of BP1002 in venetoclax-resistant AML patients ahead of schedule. In October, Bio-Path closed a $4.0 million private placement. Cash position stood at $0.6 million as of September 30, 2024.
Bio-Path Holdings (NASDAQ: BPTH) announced it will host a conference call and audio webcast on November 15, 2024, at 8:30 a.m. ET to discuss third quarter 2024 financial results and provide a business overview. The company develops DNAbilize®, an RNAi nanoparticle drug technology administered through intravenous transfusion. Their pipeline includes prexigebersen (BP1001) in Phase 2 for blood cancers, BP1001-A in Phase 1/1b for solid tumors, and BP1002 targeting Bcl-2 protein for blood cancers and solid tumors. They're also preparing an IND filing for BP1003, a STAT3 inhibitor.
Bio-Path Holdings (NASDAQ:BPTH) has closed a $4.0 million private placement priced at-the-market under Nasdaq rules. The offering included the issuance of 4,597,702 shares of common stock (or equivalents), series A warrants for up to 6,407,657 shares, and short-term series B warrants for up to 6,407,657 shares at $0.87 per share. Both warrant types have an exercise price of $1.00 per share.
The company plans to use the net proceeds for working capital and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent. Additionally, certain outstanding warrants from June 2024 were cancelled upon closing of this placement.