Lantern Pharma (NASDAQ: LTRN), a clinical-stage
biopharmaceutical company leveraging artificial intelligence (AI)
and machine learning to transform the cost, pace, and timeline of
oncology drug discovery and development, today announced a
significant advancement towards the development of a diagnostic for
its drug candidate LP-184. The diagnostic is currently based on
qRT-PCR (quantitative real-time polymerase chain reaction)
technology and is focused on quantifying the amount of PTGR1 RNA in
patient tumor samples to assess the potential for sensitivity to
Lantern’s drug candidate LP-184. The company plans to further
develop and validate the assay for its use as a potential tool for
patient selection in later stage clinical trials across a broad
range of solid tumors that have shown sensitivity to LP-184.
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Figure 1: Correlation of PTGR1 expression
and cytotoxicity/potency (IC50, µM) of LP-184 (Graphic: Business
Wire)
Lantern has successfully confirmed PTGR1 as a key biomarker that
it intends to use to optimize patient selection based on potential
tumor sensitivity to the drug candidate LP-184. LP-184 is a
precision oncology drug candidate with the potential to address
multiple solid tumors. This confirmation marks a crucial step
towards the development of a companion diagnostic and potential
stratification tool to assist with targeted patient selection.
Lantern plans on further validations and development of the assay
using qRT-PCR and partnering with central labs and cancer centers
for eventual use in patient selection and stratification. In a key
publication on the utility and value of biomarkers in oncology
trials among some of the most common cancers, titled Does biomarker
use in oncology improve clinical trial failure risk? A large‐scale
analysis by Parker, et al., 2021 in Cancer Medicine found success
of clinical trials to be significantly correlated to the
incorporation of biomarkers. In particular, the Parker, et al.
publication stated that:
“…Our overall analysis of these four cancers, independent of
indication, revealed a fivefold benefit of hazard ratios from the
Markov models, suggesting a substantial benefit from biomarker use.
The hazard ratio analysis of the Markov biomarker models examined
how likely clinical trial success was associated with biomarker use
versus no biomarker use. Hazard ratios indicated that for
biomarker‐based drugs clinical trial success was largest for breast
cancer (12‐fold) followed by melanoma (eightfold) and lung cancer
(sevenfold) …Our data provide the most extensive look at biomarker
use to date in oncology, with an advanced statistical method. Our
findings indicate that biomarkers provide a statistically
significant benefit, despite the fact our study includes biomarkers
not yet FDA approved.”
By incorporating the PTGR1 biomarker into LP-184's development
strategy, Lantern Pharma is aligning with best practices in
precision medicine and aiming to increase the likelihood of
successful clinical outcomes in future clinical trials. PTGR1
levels have been measured to be higher in certain cancer cells than
in normal cells, and Lantern is leveraging this biological activity
to target the cancer indications believed most likely to respond to
drug candidate LP-184. In the October 2023 paper in Molecular
Cancer Therapeutics, Lantern along with collaborators from Fox
Chase Cancer Center published clear evidence that higher potency of
LP-184 (measured in IC50 values) was directly correlated with
higher expressions of PTGR1 and that cancer cell lines that did not
have PTGR1 expression remained stable in the presence of LP-184
(see figure 1).
"This milestone represents a significant leap forward in our
precision oncology approach and in ensuring that we enrich our
future LP-184 clinical trials with the patients we believe will be
most likely to benefit," said Panna Sharma, CEO of Lantern Pharma.
"By working to develop a companion diagnostic for LP-184, we're not
just advancing a drug candidate; we're paving the way for more
personalized and effective cancer treatments for patients that have
the highest likelihood of benefitting from the therapy. The planned
use of biomarkers like PTGR1 in our clinical trials exemplifies our
commitment to data-driven, patient-centric drug development."
These steps toward development of this companion diagnostic
align with Lantern Pharma's commitment to leveraging cutting-edge
technology in drug development. By combining AI-driven insights
with advanced diagnostic tools, the company aims to accelerate the
drug development process and improve patient outcomes.
Lantern Pharma plans to implement this assay in upcoming
clinical trials for LP-184, potentially streamlining the
development process and increasing the likelihood of successful
outcomes. LP-184— a novel therapeutic in clinical development for
the potential treatment of malignant gliomas, pancreatic cancer,
and atypical teratoid rhabdoid tumors (ATRT)— has also been granted
an Orphan Drug Designation by the FDA, along with a Rare Pediatric
Disease Designation.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the
cost, pace, and timeline of oncology drug discovery and
development. Our proprietary AI and machine learning (ML) platform,
RADR®, leverages over 60 billion oncology-focused data points and a
library of 200+ advanced ML algorithms to help solve
billion-dollar, real-world problems in oncology drug development.
By harnessing the power of AI and with input from world-class
scientific advisors and collaborators, we have accelerated the
development of our growing pipeline of therapies that span multiple
cancer indications, including both solid tumors and blood cancers
and an antibody-drug conjugate (ADC) program. On average, our newly
developed drug programs have been advanced from initial AI insights
to first-in-human clinical trials in 2-3 years and at approximately
$1.0 - 2.5 million per program.
Our lead development programs include a Phase 2 clinical program
and multiple Phase 1 clinical trials. We have also established a
wholly-owned subsidiary, Starlight Therapeutics, to focus
exclusively on the clinical execution of our promising therapies
for CNS and brain cancers, many of which have no effective
treatment options. Our AI-driven pipeline of innovative product
candidates is estimated to have a combined annual market potential
of over $15 billion USD and have the potential to provide
life-changing therapies to hundreds of thousands of cancer patients
across the world.
Please find more information at:
- Website: www.lanternpharma.com
- LinkedIn: https://www.linkedin.com/company/lanternpharma/
- X: @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; 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 risk that our research
and the research of our collaborators may not be successful, (ii)
the risk that promising observations in preclinical studies do not
ensure that later studies and development will be successful, (iii)
the risk that we may not be successful in licensing potential
candidates or in completing potential partnerships and
collaborations, (iv) 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, (v) the risk
that no drug product based on our proprietary RADR® AI platform has
received FDA marketing approval or otherwise been incorporated into
a commercial product, and (vi) those other factors set forth in the
Risk Factors section in our Annual Report on Form 10-K for the year
ended December 31, 2023, filed with the Securities and Exchange
Commission on March 18, 2024. You may access our Annual Report on
Form 10-K for the year ended December 31, 2023 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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Investor Relations mailto: ir@lanternpharma.com ph: (972)
277-1136
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