Bio-Path Holdings Announces Completion of First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients
- Completion of the first dose cohort of the Phase 1 clinical trial marks progress in the development of BP1002
- High expression of Bcl-2 correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma
- BP1002 has shown to be a potent inhibitor against the Bcl-2 target in preclinical studies
- BP1002 has a benign safety profile, enabling potential combination therapy with approved agents
- None.
Insights
The completion of the first dose cohort in the Phase 1 clinical trial of BP1002 by Bio-Path Holdings represents a significant milestone in the development of novel therapeutics for lymphoma and chronic lymphocytic leukemia (CLL). The targeting of the Bcl-2 protein is a promising strategy, as its overexpression is a key factor in many cancers, including aggressive non-Hodgkin's lymphoma and is associated with poor prognosis. The design of BP1002, which inhibits the expression of Bcl-2 by blocking its messenger RNA, offers a different mechanism of action compared to venetoclax, which neutralizes the protein's BH3 domain.
From a clinical research perspective, the potential efficacy of BP1002 in venetoclax-refractory patients could address a significant unmet need. Given the prevalence of Bcl-2 in up to 60% of all cancers, the implications of a successful BP1002 treatment could be far-reaching. The safety profile observed so far is encouraging, as it may allow for combination therapies that could enhance treatment efficacy without compounding toxicity. The trial's standard 3+3 design is a well-established method in oncology trials to determine the maximum tolerated dose, which is crucial for establishing the safety profile of BP1002.
Bio-Path Holdings' announcement of the progression of its BP1002 drug into the next dose cohort is a pivotal development that could influence the company's market position and investor sentiment. The focus on treatment-resistant patient populations, such as those with refractory/relapsed CLL and lymphoma, taps into a niche yet critical segment of the oncology market. The biotech industry often sees increased investor interest in companies that demonstrate progress in clinical trials, especially when it involves novel mechanisms of action and potential treatment for conditions with high relapse rates.
The trial's conduct at reputable cancer centers and the involvement of recognized experts like Dr. Locke Bryan could lend credibility to the study and its findings. For stakeholders, the short-term implications include monitoring the safety and tolerability data from the upcoming dosing cohorts, which will be critical in determining the drug's future development and commercial potential. Long-term implications could include a shift in treatment paradigms for CLL and lymphoma, particularly if BP1002 demonstrates superior efficacy or a more favorable safety profile compared to existing treatments like venetoclax.
The development of BP1002 by Bio-Path Holdings underscores the importance of continuous innovation in the field of targeted cancer therapies. The drug's liposomal delivery system, encapsulating antisense oligonucleotides, is an advanced pharmaceutical technology that enables the precise targeting of cancer cells while sparing healthy tissue. This approach could potentially reduce side effects and improve patient outcomes, a significant advantage in the competitive landscape of cancer therapeutics.
Understanding the pharmacodynamics and pharmacokinetics of BP1002 will be essential in optimizing dosing regimens and predicting patient response. Moreover, the ability of BP1002 to act on the Bcl-2 protein through a different pathway than venetoclax could offer a strategic advantage in overcoming drug resistance, a common challenge in oncology. The drug's progress through Phase 1 trials is an early but critical step in validating its mechanism of action and establishing a foundation for further clinical development.
Targeting Bcl-2 Protein Offers Potential Treatment for Patients Who Have Failed or Relapsed from Venetoclax-Based Frontline Therapy
HOUSTON, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients.
“We are delighted to safely complete this first dose cohort and to advance BP1002 into the next cohort as it brings us one step closer to providing access to this very promising treatment for the most vulnerable patients who have limited therapeutic options,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We look forward to advancing this study into higher dose cohorts with the expectation that increased levels of BP1002 will prove even more efficacious and continue its safety profile in these sickest of sick patients.”
BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to
In the Phase 1 trial, refractory/relapsed CLL patients, including those who have failed or relapsed from venetoclax-based frontline therapy, as well as refractory/relapsed lymphoma patients, will be treated with BP1002. Venetoclax targets the Bcl-2 protein based on neutralizing the protein’s BH3 domain and is a frontline treatment for CLL patients and newly diagnosed, elderly acute myeloid leukemia (AML) patients. With the exception of some patients treated with allogeneic hematopoietic cell transplantation, patients treated with venetoclax-based therapies frequently relapse, primarily due to BH3 domain mutations over time. Bio-Path’s BP1002 also targets the Bcl-2 protein, but its activity is based on blocking the Bcl-2 messenger RNA and the expression of the Bcl-2 protein, and not the BH3 domain. As a result, Bio-Path believes that BP1002 could provide an alternative treatment for venetoclax refractory/relapsed CLL patients. Bio-Path also believes there may be AML patients who fail or relapse from venetoclax-based frontline treatment for the same reason, potentially representing an additional opportunity for Bio-Path to treat those patients with BP1002.
The Phase 1 clinical trial is being conducted at several leading cancer centers, including the Georgia Cancer Center, The University of Texas Southwest and New York Medical College. Locke Bryan, M.D., Associate Professor of Medicine at the Georgia Cancer Center, is serving as National Principal Investigator for the Phase 1 trial. A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days. Enrollment is now open for patients for the second dose cohort of 40 mg/m2. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and acute myeloid leukemia. In addition, an IND is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10- K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information:
Investors
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com
Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369
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