Lantern Pharma Announces First Patient Dosed in the Phase 2 Study, Harmonic™, for LP-300 in Never Smokers with Advanced Non-Small Cell Lung Cancer
March 28 2023 - 8:00AM
Business Wire
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage
biopharmaceutical company using its proprietary RADR® artificial
intelligence ("AI") and machine learning (“ML”) platform to
transform the cost, pace, and timeline of oncology drug discovery
and development, today announced the dosing of the first patient in
the Phase 2 Harmonic™ clinical trial evaluating Lantern’s
investigational new drug LP-300 in combination with chemotherapy
for never smokers with advanced non-small cell lung cancer
(NSCLC).
"Never-smokers with non-small cell lung cancer face limited
choices in therapy options after treatment with targeted therapies,
and we believe there is a great opportunity to introduce a
therapeutic regimen designed specifically for this subgroup of
cancer patients,” stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern
Pharma’s VP of Clinical Development. “These patients show
tremendous bravery and resolve in helping to establish signals of
efficacy including potential increased survival in this Phase 2
trial that combines LP-300 with standard-of-care treatment. Our
team continues to watch and monitor additional patients that are
being screened and who, after guidance from their clinicians, may
potentially enroll in the Harmonic™ trial,” continued Dr.
Ewesuedo.
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
of the patients receiving LP-300 with chemotherapy and the
remaining 1/3rd receiving chemotherapy alone. Lantern has activated
5 clinical trial sites, across 12 locations in the US including
Gabrail Cancer Center, Northwest Oncology, New York Cancer and
Blood Specialists, Texas Oncology, and Cancer and Blood Specialty
Clinic. Across the 5 Harmonic™ clinical trial sites, there is 1
dosed patient and 14 additional potential patients that have been
pre-screened and are being monitored for possible enrollment.
Multiple additional trial sites across the US are expected to be
activated in the 1st half of 2023 and will bolster patient
recruitment and enrollment.
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.
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 a clinical-stage
oncology-focused biopharmaceutical company leveraging its
proprietary RADR® AI 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.
Please find more information at: Website: www.lanternpharma.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/ Twitter:
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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
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are a number of important factors that could cause our actual
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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® AI 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, 2022,
filed with the Securities and Exchange Commission on March 20,
2023. You may access our Annual Report on Form 10-K for the year
ended December 31, 2022 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
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Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Lantern Pharma (NASDAQ:LTRN)
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