- Approximately 33% of all non-small cell lung cancer patients in
East Asia are never smokers – a growing and unaddressed patient
population.
- Dr. Yashushi Goto a leading lung cancer clinician-scientist at
the renowned National Cancer Center of Japan will be a lead
investigator.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence
(“AI”) company developing targeted and transformative cancer
therapies using its proprietary RADR® AI and machine learning
(“ML”) platform with multiple clinical-stage drug programs,
announced today that – the company has received regulatory approval
to expand its Harmonic™ trial, a Phase 2 clinical study evaluating
LP-300 in non-small cell lung cancer (NSCLC) in never-smokers in
both Japan and Taiwan. Approximately one third of all lung cancer
patients in East Asia are never-smokers and the proportion of lung
cancer in never smokers (LCINS) has been increasing gradually over
time, according to a publication in Translational Lung Cancer
Research (1).
The approval to proceed with the Phase 2 clinical trials in
Japan and Taiwan are expected to accelerate the collection of
patient and response data needed for the next-stage of evaluation
and development of LP-300, a therapeutic for the treatment of
relapsed and inoperable primary adenocarcinoma of the lung given in
combination with chemotherapy Additionally, it may also bring a
needed therapeutic option for LCINS diagnosed patients in Japan and
Taiwan, where one-third of all lung cancer diagnoses are made among
those who have never smoked. Finally, Lantern believes that this
improves the positioning for drug-candidate LP-300 to develop
collaborative and co-development partnerships with global biopharma
companies with a primary focus in serving the Asian markets.
LCINS are histologically, mutationally, and epidemiologically
distinct from smoking-related lung cancers and occur almost
exclusively as adenocarcinomas and most commonly in women and
individuals of Asian ancestry.(2) LCINS are highly enriched for
alterations in the tyrosine kinase (TK) genes, have low tumor
mutation burden (TMB) and low rates of PD-L1 expression.(2) Many of
these factors may provide clarity on why LP-300 seems to have a
distinct mechanism of action and anti-cancer activity in tumors
among LCINS patients. Lantern believes that this unique mechanism
of action and historically observed anti-tumor activity may
ultimately prove to be a useful option for this growing class of
patients globally.
Dr. Yashushi Goto, a physician and researcher focused on lung
cancer at the National Cancer Center of Japan, has been watching
the development of LP-300 and the Harmonic™ trial in the United
States with interest. Dr. Goto will now lead the trial in Japan,
where the incidence of non-small cell lung cancer (NSCLC) in
never-smokers is double or more than that of the United States. Dr.
Goto stated, “LP-300 represents a promising new treatment option
for never-smokers with advanced NSCLC harboring driver mutations
like EGFR, ALK, ROS1, and MET, who have limited choices after
progressing on targeted therapies. The Harmonic trial brings
renewed hope to those facing this devastating disease, especially
in East Asia, where EGFR mutations are highly prevalent. I am
deeply gratified to contribute to the development of this
innovative therapy that could potentially transform the treatment
landscape for never-smokers battling advanced lung cancer."
The Harmonic™ trial (NCT05456256) is a Phase 2 clinical trial
that is assessing the effect of Lantern’s investigational new drug
LP-300 in combination with standard-of-care (SOC) chemotherapy,
pemetrexed and carboplatin, on the overall and progression-free
survival of never smoker patients with advanced NSCLC. The study
has been designed as a 90 patient trial with approximately 2/3rds
(60) of the patients receiving LP-300 with a chemotherapy doublet
and the remaining 1/3rd (30) receiving the standard of care
chemotherapy doublet alone. In a previous multi-center Phase 3
clinical trial, a subset of never smoker NSCLC patients who
received LP-300 with chemotherapy showed increased overall and
two-year survival of 91% and 125%, respectively, compared to
patients who only received chemotherapy. In addition, LP-300 has
been administered in multiple clinical trials to more than 1,000
people and has been generally well tolerated. Additional
information on the Harmonic™ trial can be found at the Harmonic™
clinical trial website, on ClinicalTrials.gov, or on the
first-of-its-kind Harmonic™ trial iPhone app, which is focused on
education & awareness for never smoker NSCLC patients and the
NSCLC community.
_________________
References:
- Zhou F, Zhou C. Lung cancer in never
smokers-the East Asian experience. Transl Lung Cancer Res.
2018 Aug;7(4):450-463. https://doi.org/10.21037/tlcr.2018.05.14.
PMID: 30225210; PMCID: PMC6131183
- LoPiccolo, J., Gusev, A., Christiani, D.C. et al. Lung cancer in patients who have never smoked — an
emerging disease. Nat Rev Clin Oncol 21, 121–146
(2024). https://doi.org/10.1038/s41571-023-00844-0
About Lung Cancer in Never Smokers:
NSCLC presents differently in never smokers, which are defined
by the CDC as a person who has smoked 100 cigarettes or less in
their life, compared to smokers. These differences are believed to
be due to a higher percentage of genetic mutations in a family of
cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK
genes, such as EGFR, ALK, ROS and MET, can contribute to the
development of healthy cells into cancer cells, leading to tumor
formation and growth. LP-300’s intended mechanism is to work
together with chemotherapy by strongly interacting in the TK gene
pathways, interrupting their activity to slow or prevent tumor
growth and spread.
According to the American Cancer Society, lung cancer is the
second leading cause of cancer in the US, with over 200,000
patients diagnosed annually. Historically, never smokers with NSCLC
make up about 15-20% of all lung cancer patients, representing an
approximate annual market potential of $1.5 to $2.0 billion.
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 ADC
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
presentation 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.
Lantern Pharma Disclosure Channels to Disseminate
Information:
Lantern Pharma’s investors and others should note that we
announce material information to the public about our company and
its technologies, clinical developments, licensing matters and
other matters through a variety of means, including Lantern
Pharma’s website, press releases, SEC filings, digital newsletters,
and social media, in order to achieve broad, non-exclusionary
distribution of information to the public. We encourage our
investors and others to review the information we make public in
the locations above as such information could be deemed to be
material information. Please note that this list may be updated
from time to time.
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version on businesswire.com: https://www.businesswire.com/news/home/20240422665847/en/
Investor Relations Contact: Investor Relations at Lantern
Pharma ir@lanternpharma.com
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