- The Phase 1b clinical trial design presented at SNO2024
combines LP-184 (STAR-001) with spironolactone to potentially
enhance therapeutic response in recurrent glioblastoma (GBM)
patients.
- Preclinical data, including in previously published research by
Lantern Pharma, demonstrates up to 6-fold increase in GBM cell
sensitivity when LP-184 is combined with spironolactone.
- LP-184 continues to advance through the existing Phase 1a
clinical trial to assess safety and establish a maximum tolerated
dose (MTD); no dose-limiting toxicities have been observed to date
across nine patient cohorts enrolled.
- The clinical development for LP-184 in CNS cancers is planned
to be advanced as STAR-001 by Starlight Therapeutics in later stage
human clinical trials.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence
company transforming oncology drug development, and its
wholly-owned subsidiary Starlight Therapeutics, focused exclusively
on CNS and brain cancers, today announced the presentation of new
preclinical data and Phase 1b trial design for LP-184 (to be
developed as STAR-001 for CNS indications) in glioblastoma at the
Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston,
Texas.
The poster presentation highlighted LP-184's unique mechanism of
action, brain penetrance properties, and potential enhanced
therapeutic effect when combined with spironolactone in
glioblastoma multiforme (GBM). LP-184 is currently under
investigation in a Phase 1a dose-escalation safety study
(NCT05933265) in adult patients with advanced solid tumors
including GBM.
"The data and trial design presented at SNO2024 further validate
and progress LP-184's potential as a promising new treatment option
for glioblastoma patients," said Panna Sharma, President and CEO of
Lantern Pharma. "Through our subsidiary Starlight Therapeutics, we
are positioned to advance LP-184 as STAR-001 specifically for brain
cancers and CNS indications, where treatment options are limited
and often ineffective. The combination with spironolactone
represents an innovative approach, which has been developed with
the aid of our AI platform RADR®, to potentially enhance
therapeutic response in this devastating disease."
The key highlights from the poster presented by Dr. Schreck from
Johns Hopkins Medicine and Dr. Kulkarni from Lantern Pharma at
SNO2024 include:
- LP-184 shows favorable brain penetrance with a brain
tumor/plasma concentration ratio of 0.2 compared to 0.1 for the
existing standard of care, temzolomide.
- Preclinical studies show spironolactone increases GBM cell
sensitivity to LP-184 up to 6-fold through ERCC3 degradation –
which induces NERD (nucleotide excision repair deficiency) making
the cancer cells both more sensitive to LP-184/STAR-001 and largely
unable to repair themselves after exposure to the
drug-candidate.
- Multiple time point and dose level experiments show that GBM
cells treated with spironolactone showed significant depletion of
ERCC3 – including at 25μM of spironolactone which showed up-to 95%
depletion of ERCC3 by 24h.
- LP-184 is effective in temozolomide-resistant GBM models and is
agnostic to MGMT methylation status.
- PTGR1 expression analysis from GTEX normal brain and TCGA GBM
highlights that PTGR1 levels are higher in brain tumor tissue
(median 5.15) as compared to normal brain tissue (median
3.95).
- ERCC3-dependent TC-NER activity was identified as a determinant
of LP-184 synthetic lethality predicting that LP-184’s therapeutic
potential will be enhanced in patients with intrinsic or
spironolactone-induced NER deficient tumors.
- Phase 1b trial being considered will evaluate LP-184 as both
monotherapy and in combination with spironolactone using Simon's
2-stage optimal design in patients with IDH wild type GBM at first
progression.
Following determination of the Maximum Tolerated Dose and/or
Recommended Phase 2 Dose from the ongoing Phase 1a study, Starlight
Therapeutics plans to initiate a Phase 1b trial evaluating
LP-184/STAR-001 in two cohorts of recurrent GBM patients: one arm
which anticipates administration of STAR-001 as monotherapy and the
other arm which anticipates administration of STAR-001 in
combination with spironolactone (200 mg daily).
The trial, as currently anticipated and designed, will assess
safety, pharmacokinetics, and objective response using RANO 2.0
criteria. Additionally, the study will evaluate biomarkers
including PTGR1 expression, ERCC3 levels, and DNA damage markers to
help identify patients most likely to respond to treatment. Lantern
has previously reported on achieving significant development
milestones in the creation of a molecular diagnostic using
quantitative PCR to assess PTGR1 levels from clinical patient
samples.
LP-184 (to be developed as STAR-001 for CNS indications) is a
fully synthetic small molecule that belongs to the acylfulvene
class of alkylating agents. It induces DNA double-strand breaks and
has shown promise across a range of solid tumors, including in
preclinical GBM models. LP-184 is activated by PTGR1, which is
over-expressed in approximately 80% of recurrent GBM tumors. The
FDA has granted LP-184 both Orphan Drug and Fast Track designations
for the treatment of malignant gliomas / glioblastoma.
ABOUT STARLIGHT THERAPEUTICS
Starlight Therapeutics, a wholly owned subsidiary of Lantern
Pharma, is focused exclusively on the clinical development and
commercialization of promising oncology therapies for CNS and brain
cancers. Starlight leverages Lantern's RADR® AI platform to advance
precision medicine approaches for adult and pediatric patients with
CNS cancers, many of which have limited or no treatment options.
For more information, please visit – www.starlightthera.com .
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 platform,
RADR®, leverages billions of oncology-focused data points and a
library of 200+ advanced ML algorithms to help solve
billion-dollar, real-world problems in oncology drug development.
For more information, please visit http://www.lanternpharma.com
.
Please find more information at:
- Website: www.lanternpharma.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/20241126785516/en/
Investor Relations ir@lanternpharma.com (972)277-1136
Lantern Pharma (NASDAQ:LTRN)
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