- LP-184 is being studied in a first-in-human Phase 1 clinical
trial, having been developed with guidance from Lantern’s AI
Platform, RADR®, as a potential therapy for a wide range of
advanced solid tumors.
- LP-184 is one of two molecules in Lantern’s synthetic-lethal
franchise that has been shown to have anti-cancer activity in
tumors with DNA damage repair deficiency.
- Lantern estimates that LP-184 has a global aggregate market
potential of approximately $11-13 billion, consisting of $6-7
billion for solid tumors and $5-6 billion for CNS cancers.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence
(AI) company developing targeted and transformative cancer
therapies using its proprietary AI and machine learning (ML)
platform, RADR®, with multiple clinical stage drug programs, today
announced the dosing of the first patient in the Phase 1 clinical
trial evaluating Lantern’s investigational new drug LP-184 in
patients with advanced solid tumors.
"The first patient dosing in our Phase 1 trial of LP-184 is a
critical milestone and underscores the commitment of our team to
advancing our pipeline of therapies to patients," stated Panna
Sharma, Lantern's President and CEO. "This milestone is about more
than advancing a novel drug candidate. It also validates our unique
approach of leveraging AI and machine learning to expedite drug
development. Insights from our proprietary AI and ML platform,
RADR®, were instrumental in our development of LP-184 and aided in
understanding its mechanism of action, identifying and prioritizing
its cancer indications, and generating machine learning biomarker
signatures to assist with patient selection in future clinical
trials. The rapid advancement of LP-184 into a first-in-human Phase
1 trial underscores the immense potential that we see in this drug
candidate, as well as for our approach to AI-enabled drug
development. We believe LP-184 has blockbuster potential for
patients with multiple types of advanced solid tumors and CNS
cancers, many of which have no or limited effective therapeutic
options, and we are excited to envision the impact this could have
in transforming the lives of patients."
The single arm multicenter Phase 1 trial (NCT05933265) is
assessing the safety and tolerability of escalating doses of LP-184
to determine the maximum tolerated dose (MTD) and the recommended
Phase 2 dose (RP2D) in patients with advanced solid tumors and
recurrent high-grade gliomas, including glioblastoma (GBM). The
study has been designed as a 35 patient trial with patients
receiving LP-184 infusion on Day 1 and Day 8 of each 21-day cycle,
for a minimum of two cycles. Patients will be monitored for safety,
pharmacokinetics, and clinical activity, and dose escalation is
planned with minimum of three patient cohorts. Lantern has already
activated two clinical trial sites and plans to activate multiple
additional sites in the US over the next 100 days. Lantern
anticipates the Phase 1A portion of the trial to be completed in
the first half of 2024.
After the Phase 1 trial is completed, Lantern plans to advance
LP-184 into additional clinical trials for multiple solid tumor
indications, and Lantern’s subsidiary, Starlight Therapeutics, will
advance the clinical development of LP-184 for all brain and CNS
indications under the name STAR-001. Globally, the aggregate annual
market potential of LP-184/STAR-001’s programs is estimated to be
approximately $11-13 billion, consisting of $6-7 billion for solid
tumors and $5-6 billion for CNS cancers.
About LP-184:
LP-184 is a unique small molecule that utilizes its powerful
mechanism of action, known as synthetic lethality, to exploit
common vulnerabilities in solid tumor and CNS cancers with DNA
damage repair (DDR) deficiencies. The anti-tumor potential of
LP-184 has been demonstrated across an extensive number of in-vitro
and in-vivo cancer models, including pancreatic, bladder,
triple-negative breast cancer (TNBC), glioblastoma (GBM), brain
metastases, and ATRT. In addition to LP-184’s promise as a single
agent, its antitumor potency has the potential to be enhanced when
used in combination with existing FDA-approved agents and other
treatment modalities including spironolactone, PARP inhibitors, and
radiation therapy. Results validating LP-184’s anti-tumor potential
have been published at leading conferences and journals including,
the American Association for Cancer Research annual meeting, the
Society for Neuro-Oncology annual meeting, the San Antonio Breast
Cancer Symposium, and the Frontiers in Drug Discovery Journal.
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) RADR®
platform leverages over 34 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 including eleven
cancer indications 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 $1.0-2.0 million per program.
Our lead development programs include two Phase 2 clinical
programs and recently initiated Phase 1 clinical programs for two
additional product candidates with potential in multiple important
cancer indications. We have also established a wholly-owned
subsidiary, Starlight Therapeutics Inc., 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 (formerly Twitter): @lanternpharma
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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 biomarker
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 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, (iii) 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 (iv) 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 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/20230925269665/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Lantern Pharma (NASDAQ:LTRN)
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