DALLAS, Aug. 30, 2021
/PRNewswire/ -- Lantern Pharma (NASDAQ: LTRN), a
clinical stage biopharmaceutical company using its proprietary
RADR® artificial intelligence ("A.I.") platform to
transform the cost, pace, and timeline of oncology drug discovery
and development, today announced that the U.S. Food and Drug
Administration (FDA) has granted LP-184 Orphan Drug Designation
(ODD) for the treatment of glioblastoma multiforme (GBM) and other
malignant gliomas. This news follows the recent announcement of the
FDA granting LP-184 ODD for the treatment of pancreatic cancer.
LP-184 is a small molecule drug candidate and next generation
alkylating agent that preferentially damages DNA in cancer cells
that over-express certain biomarkers or that harbor mutations in
DNA repair pathways. LP-184 is being developed for several targeted
indications in cancer, including glioblastoma and pancreatic
cancer.
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. Analyses
driven by RADR®, Lantern's proprietary machine
learning-based artificial intelligence platform, have
identified, in clinical databases, GBMs with elevated PTGR1
expression and harboring defects in DNA damage repair components as
a targeted subset of genetically defined patients who could
potentially benefit from LP-184-based therapy. According to market
analysts at GlobalData, the global GBM market is expected to reach
$1.8 billion USD in therapy sales and
is growing at a CAGR of 12.8%.
"GBM represents an important, underserved clinical opportunity,
with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern
Pharma. "This second Orphan Drug Designation from the FDA for the
LP-184 program marks another major milestone and is further
validation of the power of our data-driven approach to oncology
drug development, aimed at more targeted and effective oncology
therapies."
"We recently reported positive preclinical data that
demonstrated LP-184 inhibits tumor growth by greater than 106% and
improved survival in animal models of GBM," continued Mr. Sharma.
"This new data that we reported, in collaboration with the Kennedy
Krieger Institute and Johns Hopkins, on
the efficacy of LP-184 in GBM cell lines, in-vivo animal models,
and in patient-derived neurospheres, validated in-silico
predictions generated by our RADR® A.I.
platform. We believe LP-184's ability to cross the
blood-brain barrier, together with its anti-tumor efficacy and
sensitivity correlations with relevant biomarkers, highlight
LP-184's potential to be used as both monotherapy as well as a
synergistic agent in combination with other drugs to address the
unmet needs in GBM and other aggressive central nervous system
tumors."
"With our extended and expanded agreement with the Kennedy
Krieger Institute and Johns Hopkins, we
look forward to further advancing the potential of LP-184 as a new,
potent treatment option for GBM, especially in areas of unmet
clinical need, including MGMT-unmethylated, temozolomide
(TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all
of which are often associated with poor prognosis and outcome for
patients."
The FDA's Office of Orphan Products Development grants orphan
status to drugs intended for the safe and effective treatment,
diagnosis or prevention of rare diseases or conditions affecting
fewer than 200,000 people in the United
States. Orphan Drug Designation is designed to provide drug
developers with various benefits to support the development of
novel drugs, including market exclusivity for seven years upon FDA
approval, eligibility for tax credits for qualified clinical
trials, waiver of marketing registration application fees, reduced
annual product fees, clinical protocol assistance and qualification
for expedited development programs.
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