DALLAS, Aug. 11, 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 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 pancreatic cancer.
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Pancreatic cancer is the fourth leading cause of cancer deaths
in the United States with a
five-year survival rate of 7.9% and a 10-year survival rate of just
1%. GLOBOCAN estimates that for pancreatic cancer there are
approximately 490,000 thousand new cases of pancreatic cancer
globally, with over 62,000 occurring in North America annually. Due to the late onset
of symptoms, patients are often diagnosed after the cancer has
progressed to locally advanced or metastatic stages of the disease.
LP-184 is designed to target a specific subset of pancreatic cancer
patients that are genetically defined, which has the potential to
increase beneficial therapeutic options for patients and may
ultimately improve survival for those with this cancer.
"Receipt of Orphan Drug Designation is an important
accomplishment for the LP-184 program and for our company. This
designation further validates our data-driven approach to oncology
drug development as well as the groundbreaking collaborative
R&D approach we are advancing with leading institutions such as
Fox Chase Cancer Center," stated Panna
Sharma, President & CEO of Lantern Pharma. "Orphan Drug
Designation is designed to provide a number of benefits, including
seven years of market exclusivity, which complements our growing
portfolio of patents that provide us additional commercial and
market protections."
"This orphan designation is one of many upcoming milestones that
we expect to achieve for our LP-184 program in pancreatic cancer.
We recently reported that LP-184 demonstrated significant and rapid
pancreatic tumor shrinkage, by over 90%, within in-vivo
mouse models over 8 weeks. In comparison, the tumors in the
untreated mice grew by over eleven-fold in volume during the same
8-week period. We are excited to advance this groundbreaking
research to help patients suffering from this devastating disease
where the benefits of current treatment options are very
limited."
Lantern has begun discussions on the design of first-in-human
clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov, an established,
NCI -funded, physician scientist and co-leader of the Marvin
& Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase
Cancer Center, as well as other key opinion leaders in the
pancreatic cancer treatment landscape.
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
seven 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
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, (iii) 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 (iv) 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