This section highlights FDA-related milestones and regulatory updates for drugs developed by Bio-Path (BPTH).
Over the past two years, Bio-Path has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BP1001, BP1001-A, BP1002, and BP1003. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BP1001 - FDA Regulatory Timeline and Events
BP1001 is a drug developed by Bio-Path for the following indication: For the treatment of acute myeloid leukemia (AML).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BP1001
- Announced Date:
- May 1, 2025
- Indication:
- For the treatment of acute myeloid leukemia (AML).
Announcement
Bio-Path Holdings, Inc today reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity.
AI Summary
Bio-Path Holdings, Inc. has announced an important milestone in its preclinical research on BP1001-A, a drug candidate aimed at treating obesity and related metabolic diseases in Type 2 diabetes patients. Recent studies revealed that BP1001-A can restore AKT activity in liver cells, which is typically decreased by a high-fat diet. This restoration helps prevent cells from becoming insulin resistant—an issue often linked to obesity and diabetes. The findings provide additional evidence that BP1001-A could be an effective treatment option for patients facing these metabolic challenges. Bio-Path conducted tests on various cell models, including liver cells, to better understand the drug’s potential benefits. The company now plans to move forward with mouse model testing to further examine its impact on body weight, insulin sensitivity, and glucose tolerance before advancing to clinical trials.
Read Announcement
BP1001-A - FDA Regulatory Timeline and Events
BP1001-A is a drug developed by Bio-Path for the following indication: Treatment for Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BP1001-A
- Announced Date:
- February 13, 2025
- Indication:
- Treatment for Advanced Solid Tumors
Announcement
Bio-Path Holdings, Inc provides an update from the Company's ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company's ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML).
AI Summary
Bio‐Path Holdings, Inc. recently updated progress from its ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients. In this trial, a heavily pretreated patient with gynecologic cancer received a higher dose (90 mg/m²) and experienced a 15% tumor reduction along with stable disease over multiple treatment cycles. This positive response highlights the potential of the company’s DNAbilize® platform, which aims to deliver targeted protein inhibition with fewer side effects compared to traditional chemotherapy.
Additionally, the company reported continuing success from its Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML). Two elderly AML patients receiving a regimen combining prexigebersen, decitabine, and venetoclax remain in complete remission, demonstrating extended treatment durability. These encouraging results support further development of innovative treatment options for patients with advanced solid tumors and AML.
Read Announcement- Drug:
- BP1001-A
- Announced Date:
- December 11, 2024
- Indication:
- Treatment for Advanced Solid Tumors
Announcement
Bio-Path Holdings, Inc outlined the growing body of scientific evidence that Bio-Path believes supports the development of BP1001-A for the treatment for obesity and related metabolic diseases in Type 2 diabetes patients.
AI Summary
Bio-Path Holdings, Inc is advancing its metabolic program by focusing on BP1001-A for obesity and related metabolic diseases in Type 2 diabetes patients. The company highlighted scientific evidence showing that reducing the expression of the protein Grb2 can improve insulin signaling. By downregulating Grb2, BP1001-A may help lower blood glucose levels by reducing insulin-induced cell growth events while enhancing metabolic processes that promote glucose uptake and storage. Preclinical models suggest that this approach is both safe and effective.
Building on robust scientific literature, Bio-Path believes that BP1001-A could restore insulin sensitivity and offer a new therapeutic avenue for obese patients with Type 2 diabetes. The company plans to complete IND-enabling testing by the fourth quarter of 2024 and aims to advance this metabolic program further in 2025.
Read Announcement- Drug:
- BP1001-A
- Announced Date:
- October 8, 2024
- Indication:
- Treatment for Advanced Solid Tumors
Announcement
Bio-Path Holdings, Inc., announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases.
AI Summary
Bio-Path Holdings, Inc. has announced the initiation of a new therapeutic program to develop BP1001-A aimed at treating obesity and related metabolic diseases. This marks the first use of the company’s proprietary DNAbilize® technology in a non-cancer application. BP1001-A works by suppressing the adaptor protein Grb2, which is believed to play a key role in insulin resistance—a major contributor to obesity and Type 2 diabetes. By downregulating Grb2 expression, the therapy is expected to improve insulin sensitivity and address the underlying causes of metabolic diseases. Bio-Path plans to start preclinical studies in the fourth quarter of 2024 to evaluate the drug’s mechanism and efficacy. If these studies are successful, the company anticipates moving forward with a Phase 1 clinical trial to further explore the therapeutic potential of BP1001-A in combating this growing health epidemic.
Read Announcement- Drug:
- BP1001-A
- Announced Date:
- August 21, 2024
- Indication:
- Treatment for Advanced Solid Tumors
Announcement
Bio-Path Holdings, Inc., today provides an update from the Company's ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company's ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML).
AI Summary
Bio-Path Holdings, Inc. announced positive updates from its ongoing clinical studies. In its Phase 1/1b trial for BP1001-A in solid tumor patients, the company reported that the first patient in the second, higher dose group (90 mg/m²) experienced a 15% reduction in her primary tumor while maintaining stable disease. This patient, who had previously received multiple treatments for gynecologic cancer, is showing promising signs without the common severe side effects associated with standard therapies.
Additionally, the company highlighted continued progress in its Phase 2 triple combination trial using prexigebersen, decitabine, and venetoclax for Acute Myeloid Leukemia (AML). Two elderly AML patients demonstrated extended treatment durability, remaining in complete remission after multiple treatment cycles. These results support the potential of Bio-Path’s DNAbilize platform for developing targeted cancer therapies for vulnerable patient populations.
Read Announcement
BP1002 (AML) - FDA Regulatory Timeline and Events
BP1002 (AML) is a drug developed by Bio-Path for the following indication: Refractory/relapsed acute myeloid leukemia (AML).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BP1002 (AML)
- Announced Date:
- February 12, 2025
- Indication:
- Refractory/relapsed acute myeloid leukemia (AML)
Announcement
Bio-Path Holdings, Inc today provides an update from the Company's ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML), including venetoclax-resistant patients.
AI Summary
Bio-Path Holdings, Inc. recently updated on its ongoing Phase 1/1b clinical trial evaluating BP1002 for treating refractory/relapsed acute myeloid leukemia (AML), including patients resistant to venetoclax. In the trial, a noteworthy response was observed when a patient in the third dosing cohort achieved stable disease and a significant reduction in blast count after just one treatment cycle. This positive outcome has encouraged the company to progress into a fourth dose cohort at a higher dose level of 90 mg/m2. According to CEO Peter Nielsen, these results offer promise for venetoclax-resistant AML patients who have very limited treatment options and typically face a poor prognosis. The study is being conducted at several leading cancer centers across the United States, with further evaluation planned to assess the safety and full potential of BP1002 in combating this challenging form of leukemia.
Read Announcement- Drug:
- BP1002 (AML)
- Announced Date:
- April 18, 2024
- Indication:
- Refractory/relapsed acute myeloid leukemia (AML)
Announcement
Bio-Path Holdings, Inc. announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients.
AI Summary
Bio-Path Holdings, Inc. announced the successful completion of the second dose cohort in the dose escalation segment of its Phase 1/1b clinical trial for BP1002. This study targets patients with refractory/relapsed acute myeloid leukemia (AML), including those who have become resistant to venetoclax, a current standard treatment. BP1002 is designed to target the Bcl-2 protein at the mRNA level, which may help overcome the resistance mechanisms seen with traditional Bcl-2 inhibitors. Enrollment has been robust, and the company has moved from a starting dose of 20 mg/m² to a higher dose of 40 mg/m². The trial will pause briefly for an FDA data review before progressing to a planned dose of 60 mg/m². This milestone is seen as vital for further FDA evaluation and for moving into the combination therapy phase with approved agents for vulnerable AML patients.
Read Announcement
BP1003 - FDA Regulatory Timeline and Events
BP1003 is a drug developed by Bio-Path for the following indication: In a variety of cancer types.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BP1003
- Announced Date:
- September 16, 2024
- Indication:
- In a variety of cancer types
Announcement
Bio-Path Holdings announced a publication highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal, Biomedicines.
AI Summary
Bio-Path Holdings recently announced a publication in the peer-reviewed journal Biomedicines that highlights the promising effects of BP1003 against several types of cancer. The study, titled "BP1003 Decreases STAT3 Expression and Its Pro-Tumorigenic Functions in Solid Tumors and the Tumor Microenvironment," shows that BP1003 can reduce STAT3 activity—a protein that often plays a role in cancer growth and drug resistance. Researchers tested BP1003 in different preclinical models, including breast, ovarian, and pancreatic cancers. The drug uses a unique neutral liposome to deliver a stable, nuclease-resistant antisense oligodeoxynucleotide directly to cancer cells, potentially improving treatment outcomes. This publication not only underlines the therapeutic potential of BP1003 across diverse tumor environments, but also marks Bio-Path’s twenty-second peer-reviewed study supporting its DNAbilize® technology.
Read Announcement
Free BPTH Stock Alerts