- New data supports the future development of LP-100 in
combination with PARP inhibitors for earlier lines of treatment
including metastatic prostate cancer and other indications where
PARP inhibitors are being utilized.
- Synergistic potency was observed for LP-100 in combination with
multiple PARP inhibitors and supported with in-silico analysis from
billions of data points and real world patient data sets from RADR®
- Lantern’s AI platform for drug development.
- Lantern is exploring development of a new clinical trial in
cancers with mutations in DDR (DNA Damage Response) genes such as
BRCA1/2 and ATM, which will build upon the results from LP-100’s
prior Phase 2 trial conducted in Denmark in metastatic
castration-resistant prostate cancer (mCRPC).
- In the Phase 2 clinical trial in Denmark, the median overall
survival (OS) for the initial group of 9 patients was approximately
12.5 months, which is an improvement over other similar fourth-line
treatment regimens for mCRPC.
- Lantern estimates that the future development of LP-100 in
combination with PARP inhibitors may increase the annual potential
market size of LP-100 targeted indications to between $700 million
and $2 billion, while also positioning the drug candidate in
multiple genomically defined DDR cancers that align with its
mechanism of action.
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 new data for its product candidate
LP-100 supporting the development of LP-100 in combination with the
class of anticancer agents known as PARP inhibitors (PARPi).
In prostate cancer mouse xenograft studies, LP-100 demonstrated
synergistic potency when used in combination with the FDA-approved
PARP inhibitor Olaparib. LP-100 also demonstrated synergy with the
FDA-approved PARP inhibitors Olaparib, Rucaparib, and Niraparib in
ovarian cancer cell line studies. The observations from these
studies are further supported by in-silico evaluation of LP-100 in
combination with PARP inhibitors using Lantern’s AI platform,
RADR®.
“The combined anti-tumor potency of LP-100 in combination with
PARP inhibitors, strongly supports the pursuit of this development
pathway for LP-100,” stated Panna Sharma, Lantern’s President and
CEO. “We also believe this development focus will enhance the
potential to position LP-100 in earlier lines of therapy, while
also opening the door to pursue treatment indications with larger
market sizes,” continued Sharma. “Exposure to LP-100 results in
double-strand DNA breaks and PARP inhibitors prevent the repair of
these types of breaks. We believe this mechanistic combination
provides a potent and highly synergistic method to eradicate
tumors.”
LP-100 and PARP inhibitors act by complementary mechanisms.
LP-100 acts by a synthetically lethal mechanism of action that
preferentially damages DNA in cancer cells lacking nucleotide
excision repair (NER) capabilities. Sensitivity to LP-100 is also
higher in tumors with homologous recombination repair (HRR)
deficiency, suggesting that this pathway is also involved in the
repair of DNA damage from LP-100. PARP inhibitors have been shown
to be effective in the treatment of tumors with HRR deficiencies.
Lantern believes the simultaneous exploitation of both these
mechanisms will enhance the development opportunities for LP-100,
while also expanding potential market opportunities for existing
PARP inhibitors.
LP-100 has previously been in a genomic signature guided Phase 2
clinical trial in Denmark where the drug candidate was used without
PARP inhibitors for patients with metastatic castration-resistant
prostate cancer (mCRPC). In this trial 9 patients (out of a
targeted enrollment of 27) were treated and had a median overall
survival (OS) of approximately 12.5 months, which is an improvement
over other similar fourth-line treatment regimens for mCRPC.
“Based on these results, the synergies of LP-100 with PARPi,
along with the increasingly narrow field of patients in mCRPC due
to the emergence of radio-ligand based therapies, we believe that
the positioning of LP-100 in an earlier and more genomically
defined setting is the best use of our resources and can lead to
improved patient outcomes,” continued Sharma.
In conjunction with its evaluation work on LP-100 with PARP
inhibitors, Lantern has been collaborating with the Danish Cancer
Society Research Center (DCSRC) to explore the future clinical
potential of LP-100 across 9 different solid tumor types that have
known deficiencies in DNA repair pathway mechanisms. This work has
included an examination of the role of NER deficiency in breast,
ovarian, prostate, lung, kidney, bladder, stomach, pancreatic, and
esophageal cancers, with the aim of identifying the most promising
patient populations for future LP-100 therapy. Lantern expects to
present additional details on the results of its collaboration with
DCSRC later this year.
Based on Lantern’s evaluation of the synergies of LP-100 with
PARP inhibitors, and the industry’s development of entirely new
classes of radio-ligand based therapy for mCRPC, the decision has
been made to close the Phase 2 clinical trial in Denmark, to allow
the focus of LP-100-directed resources on positioning the molecule
for development in earlier lines of therapy with potentially larger
market opportunities. Earlier line treatment indications where
Lantern believes LP-100 in combination with PARPi could have
potential future treatment benefits include prostate cancer
indications such as HRR gene-mutated metastatic
castration-resistant prostate cancer, ovarian cancer indications
such as first line platinum-responsive advanced ovarian cancer, and
breast cancer indications such as germline BRCA-mutated metastatic
breast cancer. The total U.S. market size of these and other
potential target development indications for the LP-100 and PARPi
combination is estimated at between $700 million and $2
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.
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 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/20230309005311/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Please find more information at: Website: www.lanternpharma.com
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