- The Harmonic™ trial is a Phase 2 multi-center study focused on
never smokers with advanced non-small cell lung cancer (NSCLC) and
will begin patient enrollment during Q3 2022.
- In a previous Phase 3 multi-center clinical trial, a subset of
never smoker patients with NSCLC receiving LP-300 with chemotherapy
showed increased overall and two-year survival of 91% and 125%,
respectively, compared to patients who received chemotherapy
alone.
- In the US in 2021 there were an estimated 24,000 to 30,000
never smoker patients diagnosed with NSCLC.
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical
company using its proprietary RADR® artificial intelligence
("A.I.") and machine learning (“ML”) platform to transform the
cost, pace, and timeline of oncology drug discovery and
development, today announced that the Food and Drug Administration
(FDA) has cleared the Company to proceed with its Phase 2 clinical
trial, Harmonic™, for its investigational new drug
LP-300. The Harmonic™ trial will be a 90 patient,
multi-center, two arm, open-label, and randomized clinical trial
evaluating LP-300 in combination with chemotherapy for never smoker
patients with advanced non-small cell lung cancer (NSCLC).
“The launch of the Harmonic™ trial is a major
milestone for LP-300. Our team is looking forward to beginning
patient enrollment during the third quarter,” said Panna Sharma,
CEO and President of Lantern. “LP-300 is an innovative therapy that
is being developed for never smokers with NSCLC, a unique and
growing population of lung cancer patients whose cancer is
genetically different from smokers with lung cancer. LP-300 will be
delivered in combination with standard of care chemotherapy.
Importantly, LP-300 has been well tolerated in prior clinical
trials and has shown potential to protect against harmful effects
of chemotherapy while also de-naturing many of the tyrosine kinase
receptors through cysteine modification that are involved with
NSCLC,” continued Sharma.
About the Harmonic™ Trial and
LP-300:
The Harmonic™ trial is a Phase 2 clinical trial
that will assess 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
of the patients receiving LP-300 with chemotherapy and the
remaining 1/3rd receiving chemotherapy alone. Lantern expects that
initial patients will be enrolled into the Harmonic™
trial during the third quarter of 2022. Enrollment is expected to
occur over the next 12 to 16 months across multiple sites in the
US.
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. LP-300 has also exhibited chemoprotective properties
that may reduce side effects from chemotherapy. Additional
information on the Harmonic™ trial can be found in the
table below and at the link for the study’s registration and
listing on the ClinicalTrials.gov website
https://clinicaltrials.gov/ct2/show/NCT05456256.
Protocol Title
A study of LP-300 with carboplatin and
pemetrexed in never smokers with advanced lung adenocarcinoma
(HARMONIC™)
Study Design
90 patient, two arm study; approximately
60 patients will receive LP-300 with pemetrexed and carboplatin,
approximately 30 patients will receive only pemetrexed and
carboplatin.
Investigational Product
LP-300 in combination with pemetrexed and
carboplatin
Summary of Key Eligibility
Criteria
Adult never smoker patients with
inoperable and advanced primary adenocarcinoma of the lung.
Patients may have received prior treatment of tyrosine kinase
inhibitors (TKIs).
Primary Outcome Measures
Progression free and overall survival
Secondary Outcome Measures
Objective response rate, duration of
objective response, clinical benefit rate
About Lung Cancer in Never Smokers:
According to the American Cancer Society lung cancer is the
second leading cause of cancer in the US. In 2021 there were an
estimated 218,000 total patients diagnosed with lung cancer
representing approximately a $11.5 billion market size.
Historically, never smokers with NSCLC make up about 15-20% of all
lung cancer patients, representing an approximate market size of
$1.5 to 2.0 billion.
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 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.
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
nine 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 drug development approach represents the potential to
deliver best-in-class outcomes. Lantern is also partnering with
leading academic institutions including Johns Hopkins, Fox Chase
Cancer Center, and UT Health Science Center – San Antonio to
accelerate the development of Lantern’s drug programs.
Please find more information at:
Website: www.lanternpharma.com LinkedIn:
https://www.linkedin.com/company/lanternpharma/ Twitter:
@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," "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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220714005308/en/
Lantern’s Investor Relations Contact: Nicole Leber Investor
Relations Associate ir@lanternpharma.com
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