- Multiple clinical trial sites across Taiwan are actively
screening patients, following successful site initiation
visits.
- Expansion into Taiwan is particularly significant as over 50%
of lung cancer cases in Taiwan occur in never-smokers.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence
(AI) company developing targeted cancer therapies using its
proprietary RADR® AI platform, today announced that the first
patient has been enrolled and dosed in Taiwan for its Phase 2
HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients
with non-small cell lung cancer (NSCLC) who have progressed after
receiving treatment with tyrosine kinase inhibitors (TKIs).
The enrollment of the first patient in Taiwan extends the recent
expansion of the HARMONIC™ trial into Asia, where there is a
notably higher prevalence of never-smoker NSCLC patients compared
to Western populations. Taiwan represents a particularly important
region for the trial, as more than half of all new lung cancer
diagnoses in Taiwan occur in people who are classified as
never-smokers. Never-smokers in the context of lung cancer have
been commonly defined, by the CDC and other health agencies, as
people who have smoked less than 100 cigarettes in their
lifetime.
"The enrollment of our first patient in Taiwan marks another
important milestone in the expansion of our HARMONIC™ trial," said
Panna Sharma, President and CEO of Lantern Pharma. "The extremely
high proportion of never-smoker lung cancer patients in Taiwan
makes this region important for accelerating our enrollment with
the objective of addressing a critical unmet need in a population
where this disease has an outsized impact."
The scientific and clinical community is increasingly
recognizing that lung cancers in nonsmokers and never-smokers
represent a distinct disease entity with unique clinical, genomic,
pathological, and biological characteristics. Lantern believes that
this has particular importance for the Harmonic™ trial, as it
underscores the need of targeted, precision therapy approaches for
this unique patient population. Lung cancer in never-smokers
constitutes one of the top 10 causes of cancer-related deaths
globally, making it a crucial focus for therapeutic innovation.
The expansion into Asia follows encouraging preliminary results
from the trial's initial safety lead-in cohort, which demonstrated
an 86% clinical benefit rate and 43% objective response rate among
the first seven patients. The HARMONIC™ trial is evaluating LP-300
in combination with carboplatin and pemetrexed in never-smoker
NSCLC patients that have relapsed following treatment with
TKIs.
Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern
Pharma commented, "The initiation of patient dosing in Taiwan
demonstrates the continued momentum of our Asia expansion strategy.
With active screening now occurring at multiple sites across both
Japan and Taiwan, we expect to see accelerated enrollment in the
trial. The enthusiasm we've seen from clinical collaborators in
Taiwan reflects the significant need for new therapeutic options
for never-smoker NSCLC patients in this region."
The Phase 2 HARMONIC™ trial is actively screening in multiple
cancer centers in the US, Japan and Taiwan and is expected to
enroll up to 90 patients across two treatment arms. The two
treatment arms are randomized, at a ratio of 2 to 1, and will
compare the co-primary endpoints of PFS (progression free survival)
and OS (median overall survival) of:
- the LP-300 arm which is expected to
enroll 60 patients (LP-300 which will be given in combination with
the standard of care chemotherapy doublet) - the SOC arm
which is expected to enroll 30 patients (the standard of care arm
will only dose patients with the chemotherapy doublet alone).
Initial results from the Phase 2 clinical trial from the lead-in
patient cohort can be reviewed in an earlier press release issued
by Lantern Pharma. Lantern plans to review, and share the interim
data from, the Phase 2 trial for PFS and OS (co-primary endpoints)
after 30 clinical events have been observed.
About LP-300
LP-300 is a disulfide small molecule and an investigational new
drug candidate. It has been well characterized to have a multimodal
mechanism of action directed towards tyrosine kinase receptors and
cell redox enzymes. It is believed to modulate cellular redox in
key signaling pathways in NSCLC and directly engage with TKI
receptors via cysteine modification.
It is known that lung carcinomas in never smoker patients have a
much higher percentage of mutations in certain tyrosine kinase (TK)
oncogenes such as EGFR, ALK, ROS, and MET-1, contributing to tumor
formation and growth, while lung carcinomas in smokers are much
more likely to have growth-driver mutations in oncogenes such as
RAS, and much lower percentages of mutations in TK oncogenes. Both
published (Parker 2015) and unpublished studies have shown that
LP-300 covalently binds to and/or inhibits the kinase activity of
each of these TK oncogenes (EGFR, ALK, ROS, and MET-1), suggesting
that a greater number of lung adenocarcinomas in never smokers,
compared to smokers, could be susceptible to the inhibitory effects
of LP-300.
LP-300 has been evaluated in 5 Phase 1 and 5 Phase 2 or 3
clinical trials in over 1,000 subjects. In a retrospective subgroup
analysis from a prior Phase 3 trial, never smoker lung
adenocarcinoma patients receiving the combination of LP-300 with
cisplatin and paclitaxel chemotherapy were observed to have
significant survival benefit compared to the never smoker patients
receiving cisplatin and paclitaxel without LP-300.
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 100 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
- Harmonic Clinical Trial: www.harmonictrial.com
- LinkedIn: https://www.linkedin.com/company/lanternpharma/
- X: @lanternpharma
FORWARD LOOKING STATEMENT:
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 observations in preclinical studies and early or
preliminary observations in clinical studies do not ensure that
later observations, studies and development will be consistent or
successful, (iii) the risk that we may not be able to secure
sufficient future funding when needed and as required to advance
and support our existing and planned clinical trials and
operations, (iv) the risk that we may not be successful in
licensing potential candidates or in completing potential
partnerships and collaborations, (v) 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, (vi) 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 (vii)
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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version on businesswire.com: https://www.businesswire.com/news/home/20241209442575/en/
Investor Relations ir@lanternpharma.com (972) 277-1136
Lantern Pharma (NASDAQ:LTRN)
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