Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company
leveraging its proprietary DNAbilize® liposomal delivery and
antisense technology to develop a portfolio of targeted nucleic
acid cancer drugs, today provides a clinical development and
operational update for 2024.
“The new year is off to a strong start as we
build off positive data generated in 2023 that compel us to advance
these studies as quickly as possible and to file for regulatory
designations that could accelerate our path to approval,” said
Peter H. Nielsen, President and Chief Executive Officer of
Bio-Path. “There is no greater challenge than the battle against
cancer, and developing effective new medicines for patients
suffering with few treatment options is what drives us every day.
The substantial progress we have made gives us further confidence
that our DNAbilize® platform is ushering in a new path of
DNA-powered medicines that can make a difference in the lives of
these patients.”
Clinical Program Overview
Bio-Path’s clinical development program consists
of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical
trials. Bio-Path is developing a molecular biomarker package to
accompany prexigebersen treatment and expects to evaluate
prexigebersen for the treatment of obesity. In addition, one
further drug candidate is in the final stages of preclinical
development, which may be submitted to the U.S. Food and Drug
Administration (FDA) later in the year in an Investigational New
Drug (IND) application.
Development of Molecular Biomarkers – Bio-Path
is developing a molecular biomarker package to accompany
prexigebersen treatment, the goal of which is to identify patients
with a genetic profile more likely to respond to treatment thereby
improving probability of success for this program. The emerging
role of biomarkers has been enhancing cancer development over the
past decade and has become a more common companion to many cancer
development programs. Bio-Path expects to develop molecular
biomarker packages to accompany its new programs.
Prexigebersen Phase 2 Clinical Trial –
Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid
Leukemia (AML) patients. This trial is comprised of three separate
cohorts of patients and treatments, each separately approvable by
the FDA as a new drug indication. The first two cohorts are
treating patients with the triple combination of prexigebersen,
decitabine and venetoclax. The first cohort includes untreated AML
patients, and the second cohort includes relapsed/refractory AML
patients. Finally, the third cohort is treating relapsed/refractory
AML patients, who are venetoclax-resistant or intolerant, with the
two-drug combination of prexigebersen and decitabine. Based on
positive interim data for safety and efficacy, the Company plans to
pursue FDA Fast Track designation for the accelerated approval of
prexigebersen for the treatment of fragile AML patients who are
unable to tolerate intensive chemotherapy and thus experience very
poor clinical outcomes. Outcomes for these older patients, who are
unable to receive intensive chemotherapy due to the challenging
side effect profile, remain suboptimal with a median survival of
only 5 to 10 months.
Phase 1/1b Clinical Trial in BP1001-A in
Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in
patients with advanced or recurrent solid tumors, including ovarian
and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is
a modified product candidate that incorporates the same drug
substance as prexigebersen but has a slightly modified formulation
designed to enhance nanoparticle properties. The Phase 1 study has
advanced to the second, higher dose level. The Phase 1b portion of
the study is expected to commence after successful completion of
the three BP1001-A monotherapy dose level cohorts and is intended
to assess the safety and efficacy of BP1001-A in combination with
paclitaxel in patients with recurrent ovarian or endometrial
tumors. Phase 1b studies are also expected to be opened in
combination with gemcitabine in Stage 4 pancreatic cancer and
combination therapy in breast cancer.
Phase 1/1b Clinical Trial in BP1002 in
Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to
treat relapsed/refractory AML patients, including
venetoclax-resistant patients, is ongoing. BP1002 targets the
protein Bcl-2, which is responsible for driving cell survival in up
to 60% of all cancers. The drug venetoclax treats AML patients by
blocking the activity of the Bcl-2 protein in AML patients.
However, patients become resistant to venetoclax. BP1002 treats the
Bcl-2 target by blocking the cell’s ability to produce Bcl-2, and
could have the potential to eliminate the need for venetoclax. AML
patients that fail frontline venetoclax-based therapy have very
poor prognosis with median overall survival of less than three
months. The first dose cohort consisted of a starting dose of 20
mg/m2, and there were no dose limiting toxicities. Enrollment is
now open for patients for the second dose cohort of 40 mg/m2.
Phase 1 Clinical Trial in BP1002 in
Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL)
– A Phase 1 clinical trial to evaluate the ability of BP1002 to
treat refractory/relapsed lymphoma and refractory/relapsed chronic
lymphocytic leukemia (CLL) patients is currently ongoing. The Phase
1 clinical trial is being conducted at the Georgia Cancer Center
while two additional clinical trial sites are currently being
activated for inclusion in the study, The University of Texas
Southwestern and New York Medical College. In January 2024,
Bio-Path announced successful completion of the first dose cohort
in the Phase 1 clinical trial. A total of six evaluable patients
are scheduled to be treated over two dose levels with BP1002
monotherapy in a standard 3+3 design, unless there is a dose
limiting toxicity which would require an additional three patients
to be tested. There were no dose limiting toxicities in the first
dose cohort (20 mg/m2). Enrollment is now open for patients for the
second BP1002 dose cohort of 40 mg/m2.
Preclinical Work for BP1003 – The Company
continues to advance its drug candidate, BP1003, for the treatment
of advanced solid tumors, including pancreatic cancer. BP1003 is an
antisense RNAi nanoparticle targeting the STAT3 protein. Plans are
to conduct a Phase 1 study of BP1003 in patients with refractory,
metastatic solid tumors (pancreatic, non-small cell lung
cancer).
Prexigebersen as Potential Treatment for Obesity
and Obesity-related Cancers – The RNAi target of prexigebersen is
the Grb2 protein, which is involved in activating the RAS/ERK
pathway for cell growth. By blocking the cell’s ability to produce
Grb2, prexigebersen treatment may limit cell growth. In obesity,
two such pathways are related to leptin and insulin. Activation of
leptin or insulin receptors can stimulate the RAS/ERK pathway via
Grb2i.
Bio-Path believes development of prexigebersen
for the treatment for obesity and obesity-related cancers could be
accelerated given the large amount of safety data from
prexigebersen treatment of leukemia patients and the continued
unmet medical need. The Company expects to evaluate prexigebersen
for the treatment of obesity as soon as corporate resources are
sufficient.
Intellectual Property
Protection
Bio-Path’s composition of matter patents protect
encroachment from third parties on its proprietary products. This
technology is solely owned by Bio-Path. These composition patents
allow the Company to apply its core technology to new protein
targets and receive new 20-year patents. Bio-Path’s patent
portfolio is as follows:
- Composition and
methods of use patents issued cover DNAbilize technology, solely
owned by Bio-Path.
- Five issued patents in the U.S. and
53 issued patents in foreign jurisdictions, providing protection in
21 countries.
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 application 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 BioPath'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.212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path
Holdings, Inc. 832-742-1369
i Casado ME et al. (2023) Recent Advances in the Knowledge of
the Mechanisms of Leptin Physiology and Actions in Neurological and
Metabolic Pathologies. Int J Mol Sci 24(2): 1422. Published online
2023 Jan 11. doi: 10.3390/ijms24021422)
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