DALLAS, Jan. 24, 2022 /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 both
Rare Pediatric Disease Designation and Orphan Drug Designation for
the company's drug candidate LP-184 for the treatment of pediatric
patients with ATRT. LP-184 is being pursued as a potential new
therapy across a range of genetically defined solid tumors,
including pancreatic cancer, GBM (Glioblastoma Multiforme)
and ATRT (Atypical Teratoid Rhabdoid Tumor).
![Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma) Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma)](https://mma.prnewswire.com/media/1216507/Lantern_Pharma_Logo.jpg)
"Historical approaches to treating pediatric ATRT such as
surgery, radiation, and chemotherapy have had largely unfavorable
long term outcomes for children, and new options are urgently
needed," said Kishor Bhatia, Ph.D.,
chief scientific officer of Lantern Pharma. "The gene SMARCB1 was
included among several genes whose expression negatively correlated
with LP-184 sensitivity in tumors. This in silico correlation was
convincingly confirmed by in vitro and in vivo assessments of
LP-184 in ATRT. The highest potency of LP-184 in-vivo has been seen
in ATRT xenografts." Dr. Bhatia continued, "Based on both the
in-silico and in-vivo observations, LP-184 has the potential to
become a critical part of the armamentarium of approved treatment
options specifically for these patients. Receiving Rare Pediatric
Disease Designation from the FDA underscores the critical value of
our growing focus on pediatric oncology indications at Lantern and
represents another significant milestone for the LP-184
program."
The National Cancer Institute (NCI) classifies ATRT as Grade IV
tumors, meaning they are malignant (cancerous), aggressive and
fast-growing. ATRTs are very aggressive childhood malignancies
of the central nervous system. The underlying genetic cause are
inactivating bi-allelic mutations in SMARCB1 (also called INI1) or
in SMARCA4. Nearly 90 percent of pediatric ATRTs are caused
by changes in the gene known as SMARCB1.
The FDA grants rare pediatric disease designation for serious
and life-threatening diseases that primarily affect children ages
18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease
Priority Review Voucher Program is intended to address the
challenges that drug companies face when developing treatments for
these unique patient populations. Under this program, companies are
eligible to receive a priority review voucher following approval of
a product with rare pediatric disease designation if the marketing
application submitted for the product satisfies certain conditions,
including approval prior to September 30,
2026 unless changed by legislation. If issued, a sponsor may
redeem a priority review voucher for priority review of a
subsequent marketing application for a different product candidate,
or the priority review voucher could be sold or transferred to
another sponsor.
Orphan drug designation is granted by the FDA Office of Orphan
Products Development to investigational treatments that are
intended for the treatment of rare diseases affecting fewer than
200,000 people in the United
States. The program was developed to encourage the
development of medicines for rare diseases, and benefits include
tax credits and application fee waivers designed to offset some
development costs, as well as eligibility for market exclusivity
for seven years post approval.
LP-184 is being developed for multiple targeted oncology
indications. Lantern Pharma intends to further advance LP-184 as a
new, potent treatment option in genetically defined subsets of
patient populations in areas of high unmet clinical need, including
pancreatic cancers, GBM, and other cancers that are DNA damage
repair deficient. The U.S. Food and Drug Administration (FDA)
has previously granted LP-184 Orphan Drug Designation for the
treatment of pancreatic cancer, and for the treatment of malignant
glioma, including GBM.
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," "upcoming," "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 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.
INVESTOR CONTACT:
Investor Relations
Dave Gentry, Redchip Companies
IR@lanternpharma.com
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SOURCE Lantern Pharma