FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-284 in Mantle Cell Lymphoma
January 05 2023 - 8:59AM
Business Wire
- The Orphan Drug Designation strengthens LP-284’s clinical
development path and provides the opportunity for additional market
exclusivity and commercial protection.
- Lantern is anticipating filing the IND with the FDA and
initiating a first-in-human Phase 1 trial for LP-284 in B-cell
non-Hodgkin’s lymphomas (NHL), including mantle cell lymphoma
(MCL), by mid 2023.
- In the US, MCL is diagnosed in approximately 4,500 patients
each year and has an estimated annual market potential of $600
million.
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage
biopharmaceutical company using its proprietary RADR® artificial
intelligence ("A.I.") and machine learning (“M.L.”) 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-284 Orphan Drug Designation
(ODD) for the treatment of mantle cell lymphoma (MCL). MCL is a
rare and aggressive form of B-cell non-Hodgkin's lymphoma (NHL)
that is typically diagnosed at advanced stages in elderly patients.
As nearly all MCL patients acquire resistance and relapse from
treatment with standard-of-care (SOC) agents, there is an urgent
and unmet clinical need for new and effective therapies to treat
MCL.
LP-284 is a novel small molecule agent that preferentially
damages DNA in cancer cells harboring mutations in DNA damage
repair pathways. Lantern is developing LP-284 for several
aggressive B-cell NHL’s, including MCL and double hit lymphoma
(DHL), where LP-284 has shown potent anti-tumor activity in
preclinical models. Lantern has been able to advance LP-284 from
initial RADR® A.I. insights regarding anti-cancer activity and
potential mechanisms of action in hematological cancers, to
selection of specific subtypes of lymphomas with superior response,
to late stage IND enabling studies and initial design of first in
human clinical trials in less than 2 years.
"Receiving Orphan Drug Designation is an important milestone for
our latest drug candidate, LP-284, and further validates our
data-driven approach to oncology drug discovery and development”
stated Panna Sharma, President & CEO of Lantern Pharma. "At
ASH, we recently reported positive preclinical data demonstrating
LP-284’s potent anti-tumor activity in new MCL tumors and also
against tumors that had grown resistant to the MCL standard-of-care
agents Ibrutinib and Bortezomib. These findings are critically
pertinent due to the high relapse rate, and poor prognosis of the
majority of MCL patients,” continued Sharma.
“This orphan designation is the fourth overall designation
granted to Lantern, with the other three granted for our drug
candidate LP-184. Acquiring these orphan designations is a key
element of our business model as they provide a number of benefits
including seven years of market exclusivity and eligibility for
expedited drug development programs. Looking forward, these
designations further position Lantern to advance our discussions
with biopharma companies for partnering and collaborative
development opportunities.”
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. ODD 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.
In addition to the ODD granted for LP-284 in MCL, Lantern was
previously granted ODD’s by the FDA for its drug candidate LP-184
for the treatment of malignant gliomas, atypical teratoid rhabdoid
tumors (ATRT), and pancreatic cancer. Lantern has also been granted
a Rare Pediatric Disease Designation for LP-184 in ATRT.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is a clinical-stage
oncology-focused biopharmaceutical company leveraging its
proprietary RADR® A.I. and machine learning platform 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
12 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.
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; expectations and estimates regarding clinical trial timing
and patient enrollment; 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 patient populations, 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," "model," "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, 2021,
filed with the Securities and Exchange Commission on March 10,
2022. You may access our Annual Report on Form 10-K for the year
ended December 31, 2021 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230105005372/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Please find more information at: Website: www.lanternpharma.com
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