- The Phase 2 HARMONIC™ study is designed for never
smokers with lung adenocarcinoma with the objective to overcome
driver mutation(s) – which are more common in never smokers – that
lead to tyrosine kinase inhibitor (TKI) treatment resistance, and
to enhance patient outcomes when LP-300 is used with the
standard-of-care chemotherapy doublet.
- In the Phase 2 lead-in cohort of 7 patients, 6 patients
experienced clinical benefit from the combination of LP-300 and
chemotherapy while 1 patient experienced progressive disease.
- Of the 6 patients experiencing clinical benefit – 3 patients
showed partial responses with an average tumor size reduction of
51% and 3 patients have stable disease with an average tumor size
reduction of 13%.
- The clinical benefit rate and disease control rate is 86% for
this group with an objective response rate (ORR) of 43%.
- A preliminary analysis of data in the safety lead-in part of
the trial indicates no additional safety concerns with no observed
dose limiting toxicities (DLTs) and no reported treatment-related
serious adverse events (SAEs).
- Encouraging preliminary efficacy results were observed
regardless of prior tyrosine kinase inhibitor (TKI) treatment(s),
demographics, and metastatic disease sites.
- In the initial set of patients, those having low to
intermediate TMB (tumor mutation burden) were found to be
responsive to LP-300 + chemotherapy.
- There are no currently approved therapies or targeted agents
specifically approved for use in NSCLC among never-smokers, which
is a growing global class of patients.
Lantern Pharma (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 positive, preliminary results from the
initial patient group in the ongoing HARMONIC™ phase 2
clinical trial. HARMONIC™ is evaluating Lantern Pharma’s
investigational new drug candidate, LP-300, in combination with
pemetrexed and carboplatin in never smokers1 with advanced
non-small cell lung cancer (NSCLC) who have progressed after
receiving treatment with a tyrosine kinase inhibitor (TKI). LP-300
was advanced in part with Lantern’s AI platform, RADR®, to aid in
the validation of mechanisms 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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240805396240/en/
Harmonic® Clinical Trial - Percent change
in cancer lesion size by patient (Graphic: Business Wire)
Summary of Harmonic™ Clinical Results
For the initial safety lead-in portion of the Phase 2 study,
which involved 7 patients, all patients received the LP-300 drug
candidate with pemetrexed and carboplatin intravenously2.
Preliminary results at the completion of the 7-patient lead-in part
of the Harmonic™ study demonstrated predictable safety
profiles that are consistent with the chemotherapy regimen alone.
No patients experienced dose limiting toxicities, and no
discontinuations were observed due to treatment related toxicity.
The most common adverse events were white blood cell count decrease
and thrombocytopenia (platelet count decrease).
Of the 7 patients enrolled in the Phase 2 lead-in stage of the
Harmonic™ trial:
- The clinical benefit rate (CBR) or disease control rate (DCR)
was 86% with 6 of the 7 patients receiving clinical benefit to
date.
- The preliminary objective response rate (ORR) was 43%, with 3
of the 7 patients having a partial response and 3 patients having
stable disease.
- The 3 partial responses include complete disappearance of
metastatic lesions and/or normalization of lymph nodes that were
abnormal at baseline and the patients experienced an average of 51%
reduction in tumor sizes as measured by RECIST criteria.
- In the 3 patients achieving stable disease, there was an
average of 13% reduction in tumor size with two patients having
distal lesions reduced by 40% in tumor size.
- One patient has been on study for 14 months, showing both a 57%
reduction in tumor size and a significant durability of
response.
- Data for the remainder (5 of 6) of these patients is not yet
mature for estimation of median duration of response and
progression free survival (PFS) at the time of data cut off
(07/25/24).
- Preliminary efficacy results were observed regardless of prior
TKI treatment(s), demographics, or metastatic disease sites,
including in patients with identified low or intermediate tumor
mutational burden (TMB); a patient group that is particularly
unresponsive to existing immuno-oncology therapies.
"These initial results from the
Harmonic™ trial provide preliminary clinical evidence of
both the safety and the mode of action for LP-300 in never-smokers
with NSCLC. To see such a high clinical benefit rate, which is part
of our secondary endpoints, this early in the trial is a motivating
factor for accelerating our enrollment globally," said Lantern VP
of Clinical Development Reggie Ewesuedo, MD, MBA.
The randomization and expansion phase of the Harmonic™
study is currently ongoing and will assess the Progression Free and
Overall Survival (PFS and OS) when patients are treated with
pemetrexed and carboplatin (with or without LP-300). The full study
design can be viewed here (clinicaltrials.gov).
Other Harmonic Clinical Trial Observations &
Updates
Never smokers with NSCLC who progress on treatment with
available TKIs are often not candidates for treatment with
checkpoint modulator immunotherapy. These patients can often be
faced with poor treatment outcomes when receiving the pemetrexed
and carboplatin chemotherapy regimen alone, which is the current
standard of care for this patient population when failing TKI
therapies. This points to a significant clinical need for
innovative and new options, especially those that present no
overlapping or added toxicities with the standard-of-care chemo
doublet.
“Preliminary results indicate
that this LP-300 triplet regimen is active against advanced NSCLC
with actionable alterations and there were no unexpected adverse
events. Also, the early Harmonic patient data indicates that the
adverse events appear to be primarily due to chemotherapy and not
the study drug,” said Janakiraman Subramanian, MD and Director of
Thoracic Oncology at Inova Schar Cancer Institute.
The proportion of never-smoking patients with non-small cell
lung cancer (NSCLC) has been significantly increasing globally over
the past 30 years, from 15% in the 1970s to 33% in the 2000s. The
high proportion of never smokers with NSCLC in East Asian countries
is of particular note with Japan estimated to be 33 to 40% of new
cases and Taiwan at over 50% of new cases.3 Lantern has received
regulatory approval to initiate the LP-300 clinical trial in
multiple Asian countries, and has started activation of sites in
Japan and Taiwan, including the National Cancer Center in Tokyo, a
globally recognized center of cancer research excellence.
Future Milestones & Activity
Lantern Pharma is committed to further advancing the triplet
combination regimen (LP-300 + pemetrexed +carboplatin) to
potentially enhance patient outcomes, with the goal of extending
and improving the lives of never smokers with advanced NSCLC
adenocarcinoma. While this data is promising, Lantern will continue
collecting and analyzing additional patient response and clinical
data from sites in the US and Asia. If the additional data confirms
our preliminary findings for clinical benefit and/or objective
response rates, Lantern will consider applying for a Breakthrough
Therapy designation. According to the FDA, Breakthrough Therapy
designation is a process designed to expedite the development and
review of drugs that are intended to treat a serious condition and
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s). No therapy has been
specifically approved for never-smokers with NSCLC making this a
significant and growing global clinical need, estimated by Lantern
to be over $2 billion USD in annual market potential.
The Harmonic™ study has progressed to the randomization
and expansion phase where up to an additional 80 patients will be
placed into either the LP-300 + standard-of-care chemotherapy
doublet arm or the standard-of-care chemotherapy doublet arm
without LP-300. The arm with LP-300 will enroll patients on a 2 to
1 ratio versus the arm with doublet chemotherapy alone. The study
is designed to progress based on the 2 to 1 randomization in all
sites across the US and Asia. Lantern plans to review, and share
the interim data from, the Phase 2 trial for PFS and OS (co-primary
endpoints) after 30 clinical events have been observed.
Lantern also anticipates further using RADR® to determine
potential additional suitability for LP-300 in combination with
other approved agents for the control of cancer progression in
other patient subgroups. Lantern has developed and published on
LP-300 as a potential first-in-class combination agent with
tyrosine kinase inhibitors (TKIs) in non-smoker lung adenocarcinoma
which could extend the potential of the drug-candidate into earlier
segments of NSCLC care. On Thursday, August 8th Lantern’s
management will provide additional details on the positive Phase 2
trial results as well as clinical and scientific insight from the
Harmonic™ study during the Company’s 2nd quarter earnings call at
4:30pm Eastern which can be accessed via Zoom webinar
registration.
About The HARMONIC™ Clinical Trial
The HARMONIC™ trial is designed as a multicenter, open
label, multi-country Phase 2 trial with planned enrollment of
approximately 90 patients. Patients who are never smokers with
NSCLC adenocarcinoma and have relapsed after prior treatment with
tyrosine kinase inhibitors will be eligible for enrollment.
Following the safety lead-in stage, the trial will consist of
randomization in a 2:1 allocation ratio of patients to one of two
arms: Arm A (LP-300 + carboplatin, + pemetrexed) or Arm B
(carboplatin + pemetrexed).
About LP-300
LP-300 is a disulfide small molecule and an investigational new
drug candidate. It has been well characterized to have a multimodal
mechanism of action directed towards tyrosine kinase receptors and
cell redox enzymes. It is believed to modulate cellular redox in
key signaling pathways in NSCLC and directly engage with TKI
receptors via cysteine modification.
It is known that lung carcinomas in never smoker patients have a
much higher percentage of mutations in certain tyrosine kinase (TK)
oncogenes such as EGFR, ALK, ROS, and MET-1, contributing to tumor
formation and growth, while lung carcinomas in smokers are much
more likely to have growth-driver mutations in oncogenes such as
RAS, and much lower percentages of mutations in TK oncogenes. Both
published (Parker 2015) and unpublished studies have shown that
LP-300 covalently binds to and/or inhibits the kinase activity of
each of these TK oncogenes (EGFR, ALK, ROS, and MET-1), suggesting
that a greater number of lung adenocarcinomas in never smokers,
compared to smokers, could be susceptible to the inhibitory effects
of LP-300.
LP-300 has been evaluated in 5 Phase 1 and 5 Phase 2 or 3
clinical trials in over 1,000 subjects. In a retrospective subgroup
analysis from a prior Phase 3 trial, never smoker lung
adenocarcinoma patients receiving the combination of LP-300 with
cisplatin and paclitaxel chemotherapy were observed to have
significant survival benefit compared to the never smoker patients
receiving cisplatin and paclitaxel without LP-300.
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 The U.S. Centers for Disease Control
defines a never-smoker as someone who has smoked < 100
cigarettes per lifetime. A link to the definition is provided
here.
2 Patients in the lead-in cohort of seven
patients all received LP-300 in conjunction
with carboplatin and pemetrexed intravenously on day one of
21-day cycles for up to four to six cycles. Dosing was established
at: LP-300 at 18.4g/m2; pemetrexed at 500mg/m2; and, carboplatin at
5 milligram per milliliter (mg/mL) per minute (AUC5) intravenously
on day one of 21-day cycles for four to six cycles. After four to
six cycles of therapy (number of cycles was determined by
Investigator discretion), patients continue pemetrexed maintenance
therapy if patients have evidence of clinical benefit and are not
experiencing unacceptable treatment-related toxicity.
3 Zhou F, Zhou C. Lung cancer in never
smokers-the East Asian experience. Transl Lung Cancer Res. 2018
Aug;7(4):450-463. doi: 10.21037/tlcr.2018.05.14. PMID: 30225210;
PMCID: PMC6131183.
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Investor Relations mailto: ir@lanternpharma.com ph: (972)
277-1136
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