Lantern Pharma Receives Pre-IND Feedback from the FDA, Clearing a Path for Drug Candidate LP-184’s Phase 1 Clinical Trial in Q2 2023
January 17 2023 - 8:00AM
Business Wire
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 it has received guidance from the
United States Food and Drug Administration (FDA) on Lantern’s
clinical development plans for its LP-184 program. LP-184 has shown
nanomolar potency across a range of cancers including several solid
tumors and multiple adult and pediatric central nervous system
(CNS) cancers. The FDA feedback clears Lantern’s path for an IND
submission and the targeted initiation of a first-in-human clinical
trial in Q2 2023.
During Q4 2022, Lantern requested a pre-investigational new drug
(pre-IND) meeting with the FDA, requesting agency feedback in
connection with its planned LP-184 IND application. The FDA’s
responses and guidance have been aligned with the company’s
clinical, CMC, and preclinical development plans and solidifies
Lantern’s timeline for an IND submission and clinical trial
initiation in Q2 2023. The upcoming LP-184 Phase 1 trial is
expected to enroll patients with pancreatic cancer, select solid
tumors with DNA damage repair deficiency, and malignant
gliomas-including glioblastoma (GBM). The FDA previously granted
Lantern Orphan Drug Designations (ODD) for LP-184 in both
pancreatic cancer and malignant gliomas.
The upcoming LP-184 first-in-human Phase 1 trial is expected to
include patients across a range of solid tumor types, including
adult brain and central nervous system (CNS) cancers. CNS cancer
patients have some of the lowest 5-year cancer survival rates and
have had little to no meaningful treatment progress in nearly two
decades. LP-184’s anti-tumor synthetic lethality mechanism of
action, favorable blood brain permeability, and compelling
pre-clinical efficacy for CNS cancers give it the potential to
become the next generation standard-of-care agent for CNS cancer
patients.
“We expect to have multiple cancer indications and sub-types in
this upcoming LP-184 trial that have been identified with the help
of our A.I. platform, RADR®. The identification and preclinical
validation of these indications has been accomplished in timelines
that are typically unheard of in oncology drug development. This
gives us a unique advantage of generating multiple meaningful and
clinically needed programs that we can develop, partner, and
monetize for the benefit of our shareholders and for cancer
patients,” stated Panna Sharma, Lantern’s President and CEO. “Our
team has been very focused on aligning multiple workstreams to make
for an impactful launch of our LP-184 Phase 1 program later this
year across multiple cancer types that have the molecular
characteristics for sensitivity to this exciting new drug
candidate,” continued Sharma.
Lantern’s LP-184 program has benefitted from involvement and
collaboration with top academic centers including the Kennedy
Krieger Institute at Johns Hopkins, Fox Chase Cancer Center, The
Danish Cancer Society Research Center, and the Greehey Children’s
Cancer Research Institute at University of Texas Health Science
Center, San Antonio. These collaborations have been a key component
of further validating and focusing the clinical potential of LP-184
for patient groups with high unmet need.
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. 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/20230117005407/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Please find more information at: Website: www.lanternpharma.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/ Lantern
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