- Fast Track Designation is designed to expedite FDA review of
important new drugs to treat serious conditions and fill an unmet
medical need.
- Fast Track Designation for LP-184 (STAR-001) recognizes
Glioblastoma (GBM) as a serious condition impacting more than
13,000 U.S. adults each year and approximately 300,000
globally.
- A phase 1b/2a clinical trial for recurrent GBM is targeted to
start in late 2024/early 2025.
- LP-184, which will be developed as STAR-001 for CNS and other
neuro-oncology indications by Starlight Therapeutics, a wholly
owned subsidiary of Lantern Pharma, has the potential to be the
first new drug for treating GBM in more than 20 years.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence
(AI) company dedicated to developing cancer therapies and
transforming the cost, pace, and timeline of oncology drug
discovery and development, today announced that the FDA has granted
Fast Track Designation for investigational drug candidate, LP-184,
for treatment of Glioblastoma. LP-184 is currently in a Phase 1A
clinical trial designed to evaluate the safety and tolerability of
the synthetically lethal investigational drug candidate in a broad
range of solid tumors, including Glioblastoma (GBM). LP-184 was
optimized and advanced in part with Lantern’s AI platform, RADR®,
to aid in the validation of mechanisms that could be exploited in
the clinical setting to eradicate challenging cancers, and uncover
insights in targeted patient populations. RADR® is Lantern’s AI
platform for cancer therapy discovery, development and rescue with
over 100 billion data points and aiding in the development of both
Lantern’s portfolio and development initiatives with Lantern’s
collaborators.
About GBM and the need for improved and novel
therapies.
Glioblastoma (GBM) affects nearly 13,000 patients annually in
the US and approximately 300,000 globally, with a mortality rate of
94%. Current standard of care therapies result in a life expectancy
in GBM patients of less than 15 months. A major limitation to
development of new drugs in the treatment of GBM is the need for
potential drugs to have the ability to cross the blood brain
barrier (BBB) as well as the ability to counteract the inherent and
adaptive resistance of GBM cancer cells to temozolomide, the
current standard of care in GBM. This resistance is largely derived
from the expression of the DNA repair enzyme MGMT1. LP-184 activity
is agnostic to MGMT expression, meaning it does not depend on the
under or over-expression of MGMT in GBM and has shown in-vivo,
preclinical activity in both types of GBM models.
No new drugs for GBM have been approved in over two decades.
Lantern Pharma is advancing LP-184, a molecule which demonstrates
synthetic lethality when combined with agents that cause DNA damage
repair deficiency.2 Additionally, LP-184 has shown that it causes
double-stranded breaks in the DNA of recurrent GBM (rGBM) cancer
cells in multiple in-vivo models and is currently being advanced in
early clinical stage studies.
“Receiving FDA Fast Track Designation for Lantern Pharma’s
LP-184 in GBM reinforces our belief that this drug-candidate can
help in the critical need to find effective treatment options for
patients with GBM and further supports the potential of LP-184 to
address the challenges in aggressive CNS cancers, where patients
have a critical need for novel and life extending therapies” said
Panna Sharma, President and CEO of Lantern Pharma.
Current status of LP-184 & STAR-001 in clinical trials
& development
LP-184 is currently being studied in a phase 1A clinical trial
to evaluate the safety, tolerability and maximum tolerated dose
(MTD) of the potential therapy in a wide range of tumors, including
GBM. The full study design can be viewed here (clinicaltrials.gov).
Once the MTD has been established, Lantern has plans to advance the
drug-candidate LP-184 as STAR-001 through its wholly owned
subsidiary, Starlight Therapeutics, in GBM and other CNS and brain
cancers.
Lantern also anticipates further using RADR® to determine
potential additional suitability for LP-184 in combination with
other approved agents for the control of cancer progression in
multiple other patient subgroups. Lantern has provided information
on the development of LP-184 in GBM and has also discussed its plan
to advance STAR-001 (LP-184 for CNS cancers) in multiple publicly
available webinars, including on:
- June 26, 2024 — STAR-001 in Multiple Brain and CNS Cancers with
Dr. Marc Chamberlain, and
- July 31, 2024 — Born from AI, Lighting The Way in CNS Cancer
Treatment with Mr. Panna Sharma.
The proposed goals for the development of Phase 1b/2a clinical
studies are targeting a rGBM specific trial to begin in late 2024
or early 2025. This trial is being planned to assess LP-184 in a
Phase 1b/2a study as mono-therapy and in combination with
spironolactone in rGBM to assess safety, pharmacokinetics and
preliminary efficacy. Concurrently, Lantern will conduct a
retrospective correlative analysis of multiple key markers of DNA
damage as exploratory endpoints. EGFR expression or mutation
status, MGMT status and expression of DNA damage repair pathway are
also planned to be studied as potential response predictors to help
inform and guide future late-stage trials and to stratify
enrollment.
About the FDA Fast Track process
The FDA’s Fast Track process is designed to facilitate
development and expedite the review of therapies intended to treat
serious conditions and address unmet medical needs to potentially
bring important new medicines to patients sooner. Companies whose
programs are granted Fast Track Designation are eligible for more
frequent interactions with the FDA during clinical development. For
more information on Fast Track designation, please visit the FDA’s
website at
www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
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
- 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 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 successful in
licensing potential 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 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.
1 In patients with glioblastoma (GBM) an aggressive and severe
type of brain tumor, the cancer medicine temozolomide is more
effective in those with a methylation of the gene's promoter.
Overall, MGMT methylation or hyper-methylation is associated with
prolonged patient survival in clinical prediction models, while
under-methylation or no-methylation can be derived as a result of
exposure to temozolomide and cause resistance to temozolomide
therapy and therefore no benefit from the use of temozolomide in
GBM.
2 Bachchu Lal, Aditya Kulkarni, Joseph McDermott, Rana Rais,
Jesse Alt, Ying Wu, Hernando Lopez-Bertoni, Sophie Sall, Umesh
Kathad, Jianli Zhou, Barbara S. Slusher, Kishor Bhatia, John
Laterra; Preclinical Efficacy of LP-184, a Tumor Site Activated
Synthetic Lethal Therapeutic, in Glioblastoma. Clin Cancer Res 15
October 2023; 29 (20): 4209 4218.
https://doi.org/10.1158/1078-0432.CCR-23-0673
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241015926202/en/
Investor Relations mailto: ir@lanternpharma.com ph: (972)
277-1136
Lantern Pharma (NASDAQ:LTRN)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Lantern Pharma (NASDAQ:LTRN)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024
