DALLAS and BALTIMORE,
Aug. 19, 2021 /PRNewswire/
-- Lantern Pharma (NASDAQ: LTRN), a clinical stage
biopharmaceutical company, announced today that a successful
preclinical study has shown its drug candidate LP-184 is able to
inhibit tumor growth and improve survival in animal models of
glioblastoma (GBM). This study was conducted in collaboration with
the research group of John Laterra,
M.D., Ph.D., at Kennedy Krieger Institute, which is affiliated with
Johns Hopkins University. Lantern had
previously announced the initiation of this GBM focused
collaboration with Dr. Laterra in December of 2020.
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Recent in vitro and in vivo data from this collaboration on the
efficacy of LP-184 in GBM cell lines, patient-derived neurospheres
and mice models validated in-silico predictions generated by
RADR® on the efficacy of the drug candidate.
RADR® is Lantern's proprietary machine learning-based
artificial intelligence platform that integrates data analytics,
experimental biology and large-scale genomic analysis to transform
the cost, pace and timeline of oncology drug discovery and
development.
In the research done with Johns
Hopkins, LP-184 treatment induced tumor regression evidenced
by greater than 106% tumor growth inhibition in two subcutaneous
xenograft models of GBM (U87 and M1123). LP-184 also prolonged
survival in mice bearing an intracranially implanted tumor model of
GBM (U87), as compared with those that did not receive any drug
substance. Intravenous administration of LP-184 over two
cycles reduced subcutaneous xenograft tumor volume in mice by
greater than 85% within the treatment group. In the orthotopic GBM
xenograft tumor model in mice, a single cycle of LP-184 resulted in
a statistically significant (p < 0.0001) extension of median
overall survival in the LP-184-treated group (42 days) versus the
control group (33 days). Lantern expects to further refine the
dosing regimen and cycle in the next phase of work with the
expectation that additional improvements in survival can be
translated into human clinical trials.
Results from this ongoing translational research program
highlight the promising in vivo anti-tumor effect of LP-184 in
multiple GBM xenograft models and are expected to help guide the
clinical application and focus of the drug candidate. Data from
this study will be used to power future insights and analyses
provided by RADR®, in addition to further enhancing the
signature of response for LP-184 in genomically-defined
GBM. Additionally, these findings are expected to support
Lantern Pharma's orphan drug designation application to the FDA for
the use of LP-184 in the treatment of glioblastoma. The study's
observations and detailed results are being prepared for
peer-reviewed publications and scientific conferences.
GBM is a rare disease with an overall five-year survival rate of
5%. This means that only approximately 5 in 100 people survive GBM
for five years and beyond. In 2020, 12,000 new GBM cases were
diagnosed in the U.S. and more than 154,000 new cases were
diagnosed worldwide. LP-184 acts by damaging DNA selectively in
tumors that express high levels of the enzyme PTGR1. RADR-driven
analyses have identified, in clinical databases, GBMs with elevated
PTGR1 expression and harboring defects in DNA damage repair
pathways as a targeted subset of genetically defined patients who
could potentially benefit from LP-184-based therapy.
"This new data reinforces that LP-184 may have clinical utility
for the treatment of primary and metastatic brain cancers," says
Panna Sharma, Lantern Pharma's chief
executive officer. "We believe that LP-184's molecular features and
distinct mechanism of action, anti-tumor efficacy and strong
correlation with specific biomarkers have the potential to provide
a unique and powerful approach aimed at addressing high unmet needs
in GBM and other aggressive CNS tumors. With this exciting data, we
look forward to continuing our work with Dr. Laterra evaluating the
potential of LP-184 as a new, potent treatment option for GBM,
especially in areas not adequately addressed today, including
MGMT-unmethylated, TMZ-resistant, EGFR-aberrant and recurrent GBMs
associated with poor prognosis."
Based on these observations, Lantern recently extended and
expanded its collaborative agreement with Kennedy Krieger Institute
and Johns Hopkins. The objectives of
the expanded agreement include further validation of in-silico and
other experimental results that support the observation that LP-184
can be an effective treatment in GBM regardless of MGMT (a DNA
repair enzyme) status of the cancer. This has significant potential
to provide a much-needed alternative to the standard-of-care drug,
temozolomide (TMZ), especially in GBMs that over-express MGMT —
which can be up to 50% of GBM cancers. These patients that have
GBMs that over-express MGMT are generally unresponsive to TMZ and
need new therapy options that can exploit other molecular pathways
and mechanisms. Development of an agent with efficacy in GBM,
regardless of its MGMT methylation status, would be an important
advance towards addressing a critical gap in the current standard
of care.
Lantern's RADR® platform has also identified a subset
of GBM with a low expression of nucleotide excision repair (NER)
genes as being responsive to LP-184. Since NER is a critical
mechanism for the repair of DNA damage induced by LP-184, the
collaboration will further examine the enhanced sensitivity of this
subset of GBM cancers to LP-184. In parallel, Lantern is also
engaging in an additional study with Johns
Hopkins to determine the pharmacokinetics and
pharmacodynamics of LP-184 as it relates to the central nervous
system (CNS) which has the potential to help uncover additional CNS
cancers where LP-184 can play a key therapeutic role.
This research at the Kennedy Krieger Institute is being
conducted in collaboration with Dr. Laterra, a professor in the
Departments of Neurology, Neuroscience and Oncology at The
Johns Hopkins University School of
Medicine and a research scientist at Kennedy Krieger
Institute. He is the director of the Division of Neuro-Oncology in
the Department of Neurology at Johns
Hopkins. Dr. Laterra's laboratory focuses on the cellular
and molecular biology of primary brain tumor malignancy, with the
combined goals of defining basic mechanisms and translating these
discoveries into experimental therapeutics. He is particularly
interested in the molecular mechanisms, as well as the potential
therapeutic interventions, to reverse glioma cell growth and
survival pathways, and in the functioning of the blood-brain and
blood-tumor barriers.
About Lantern Pharma
Lantern Pharma (LTRN) is a
clinical-stage oncology-focused biopharmaceutical company
leveraging its proprietary RADR® A.I. platform and machine learning
to discover biomarker signatures that identify patients most likely
to respond to its pipeline of genomically-targeted therapeutics.
Lantern is currently developing four drug candidates and an ADC
program across eight disclosed tumor targets, including two phase 2
programs. By targeting drugs to patients whose genomic profile
identifies them as having the highest probability of benefiting
from the drug, Lantern's approach represents the potential to
deliver best-in-class outcomes. More information is available at:
www.lanternpharma.com and Twitter @lanternpharma.
Forward-looking Statements
This press release contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements include, among other things, statements relating to:
future events or our future financial performance; the potential
advantages of our RADR® platform in identifying drug candidates and
patient populations that are likely to respond to a drug candidate;
our strategic plans to advance the development of our drug
candidates and antibody drug conjugate (ADC) development program;
estimates regarding the development timing for our drug candidates
and ADC development program; our research and development efforts
of our internal drug discovery programs and the utilization of our
RADR® platform to streamline the drug development process; our
intention to leverage artificial intelligence, machine learning and
genomic data to streamline and transform the pace, risk and cost of
oncology drug discovery and development and to identify patient
populations that would likely respond to a drug candidate;
estimates regarding potential markets and potential market sizes;
sales estimates for our drug candidates and our plans to discover
and develop drug candidates and to maximize their commercial
potential by advancing such drug candidates ourselves or in
collaboration with others. Any statements that are not statements
of historical fact (including, without limitation, statements that
use words such as "anticipate," "believe," "contemplate," "could,"
"estimate," "expect," "intend," "seek," "may," "might," "plan,"
"potential," "predict," "project," "target," "objective," "aim,"
"should," "will," "would," or the negative of these words or other
similar expressions) should be considered forward-looking
statements. There are a number of important factors that could
cause our actual results to differ materially from those indicated
by the forward-looking statements, such as (i) the impact of the
COVID-19 pandemic, (ii) the risk that our research and the research
of our collaborators in the area of glioblastoma and other central
nervous system cancers may not be successful, (iii) the risk that
none of our product candidates has received FDA marketing approval,
and we may not be able to successfully initiate, conduct, or
conclude clinical testing for or obtain marketing approval for our
product candidates, (iv) the risk that no drug product based on our
proprietary RADR A.I. platform has received FDA marketing approval
or otherwise been incorporated into a commercial product, and (v)
those other factors set forth in the Risk Factors section in our
Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and
Exchange Commission on March 10,
2021. You may access our Annual Report on Form 10-K for the
year ended December 31, 2020 under
the investor SEC filings tab of our website at
www.lanternpharma.com or on the SEC's website at www.sec.gov. Given
these risks and uncertainties, we can give no assurances that our
forward-looking statements will prove to be accurate, or that any
other results or events projected or contemplated by our
forward-looking statements will in fact occur, and we caution
investors not to place undue reliance on these statements. All
forward-looking statements in this press release represent our
judgment as of the date hereof, and, except as otherwise required
by law, we disclaim any obligation to update any forward-looking
statements to conform the statement to actual results or changes in
our expectations.
CONTACTS:
Investor Relations
David Waldman, Crescendo
Communications, LLC
ir@lanternpharma.com
212-671-1021
Public Relations
Nicholas Koulermos, Vice President —
5W Public Relations
lantern@5wpr.com
646-843-1812
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SOURCE Lantern Pharma