Matinas BioPharma Announces Positive in vivo Efficacy Results of Oral LNC Docetaxel Formulation in a Melanoma Model
November 07 2023 - 7:30AM
Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a
clinical-stage biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
technology, announces positive results from an in vivo animal study
of an oral LNC formulation of docetaxel, a well-known
chemotherapeutic agent used in the management of multiple
metastatic and unresectable tumors. Currently, docetaxel is
administered intravenously and can be associated with significant
side effects and toxicities.
“We are excited to report new in vivo data
demonstrating the therapeutic efficacy of an oral LNC formulation
of docetaxel,” said Dr. James J. Ferguson, Chief Medical Officer of
Matinas. “We believe this is a step forward for Matinas’ unique
drug delivery platform, taking us beyond our successes in
infectious disease by providing convincing proof-of-principle that
orally administered LNCs can effectively target tumors and
successfully deliver small molecule therapeutics to those
tumors.
“The study shows reductions in tumor size
comparable to systemic intravenous docetaxel in a well-validated
mouse melanoma model,” he added. “We observed no toxicity with our
LNC formulations over the 10 days of oral dosing, noting this
relatively short course of treatment was primarily targeting
efficacy and will require further study and evaluation with longer
periods of administration. Additional analyses of the data are
ongoing, and we are preparing them for presentation at upcoming
scientific meetings.”
Study Design
Purpose: Document the efficacy of an oral LNC
docetaxel formulation to target and treat tumors, with both
negative (untreated) and positive (IV docetaxel) controls.
- Syngeneic tumor model (C57BL/6 mice
injected with B16F10 murine melanoma cells)
- Four treatment groups
- Untreated controls
- Low-dose oral LNC docetaxel
- High-dose oral LNC docetaxel
- IV docetaxel
- Dosing of oral LNCs and IV
docetaxel initiated at Day 5 following tumor cell injection
- Low-dose and high-dose oral LNC
arms dosed daily through Day 14
- IV docetaxel administered on Day 5
and Day 10
- Tumor volume (caliper measurements)
measured throughout the course of treatment
- Toxicity monitored throughout
treatment and assessment of hematologic parameters at Day 14
- Animal sacrifice at Day 14
- Tumor volume measured at Day
14
Key Findings
- Efficacy: Anti-tumor effect of
daily oral LNC docetaxel in both the high-dose and low-dose arms
were comparable to IV docetaxel with statistically significant
reductions in tumor volume compared with untreated controls at Day
14 (high dose oral LNC -63%; low dose oral LNC -57%; IV docetaxel
-68%), and similar reductions in tumor weight at Day 14.
- Safety: No systemic toxicities were
noted. Body weight was stable over treatment duration and
hematologic parameters were similar to untreated controls.
Potential next steps for Matinas include
evaluating the efficacy of the current LNC docetaxel formulation in
other tumor models and evaluating longer-term treatment regimens to
confirm lack of toxicity. Additionally, Matinas plans to evaluate
the potential anti-tumor activity of LNC formulations of small
oligonucleotides.
About Matinas BioPharmaMatinas
BioPharma is a biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology.
Matinas’ lead LNC-based therapy is MAT2203, an
oral formulation of the broad-spectrum antifungal drug amphotericin
B, which although highly potent, can be associated with significant
toxicity. Matinas’ LNC platform provides oral delivery of
amphotericin B without the significant nephrotoxicity otherwise
associated with IV-delivered formulations. MAT2203 also allows for
safe, longer-term use outside of a hospital setting, which could
have substantial favorable pharmacoeconomic impact. MAT2203 was
successfully evaluated in the completed Phase 2 EnACT study in
cryptococcal meningitis, meeting its primary endpoint and achieving
robust survival. MAT2203 will be further evaluated as an oral
step-down monotherapy treatment following IV amphotericin B in a
single pivotal Phase 3 study in the treatment of aspergillosis in
persons with limited treatment options who are unable to be treated
with azoles for reasons related to drug-drug interactions,
resistance or for whom these antifungal agents are unable to be
used for other clinical reasons.
In addition to MAT2203, preclinical and clinical
data have demonstrated that this novel technology can potentially
provide solutions to many of the challenges standing in the way of
achieving safe and effective intracellular delivery of both small
molecules and larger, more complex molecular cargos such as RNAi,
antisense oligonucleotides, and vaccines. The combination of its
unique mechanism of action and flexibility with routes of
administration (including oral) positions Matinas’ LNC technology
to potentially become a preferred next-generation orally available
intracellular drug delivery platform. For more information, please
visit www.matinasbiopharma.com.
Forward-looking StatementsThis
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including
those relating to our business activities, our strategy and plans,
our collaboration with National Resilience, Inc., the potential of
our LNC platform technology, and the future development of its
product candidates, including MAT2203, the Company’s ability to
identify and pursue development, licensing and partnership
opportunities for its products, including MAT2203, or platform
delivery technologies on favorable terms, if at all, and the
ability to obtain required regulatory approval and other statements
that are predictive in nature, that depend upon or refer to future
events or conditions. All statements other than statements of
historical fact are statements that could be forward-looking
statements. Forward-looking statements include words such as
"expects," "anticipates," "intends," "plans," "could," "believes,"
"estimates" and similar expressions. These statements involve known
and unknown risks, uncertainties and other factors which may cause
actual results to be materially different from any future results
expressed or implied by the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
continue as a going concern, our ability to obtain additional
capital to meet our liquidity needs on acceptable terms, or at all,
including the additional capital which will be necessary to
complete the clinical trials of our product candidates; our ability
to successfully complete research and further development and
commercialization of our product candidates; the uncertainties
inherent in clinical testing; the timing, cost and uncertainty of
obtaining regulatory approvals; our ability to protect the
Company’s intellectual property; the loss of any executive officers
or key personnel or consultants; competition; changes in the
regulatory landscape or the imposition of regulations that affect
the Company’s products; and the other factors listed under "Risk
Factors" in our filings with the SEC, including Forms 10-K, 10-Q
and 8-K. Investors are cautioned not to place undue reliance on
such forward-looking statements, which speak only as of the date of
this release. Except as may be required by law, the Company does
not undertake any obligation to release publicly any revisions to
such forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events. Matinas BioPharma’s product candidates are all in a
development stage and are not available for sale or use.
Investor Contact
LHA Investor RelationsJody
CainJcain@lhai.com310-691-7100
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