- The trial targets never-smoker non-small cell lung cancer (“NSCLC”) patients, a group with limited treatment options.
- Japan’s high incidence of never-smoker NSCLC makes it a strategic region for the trial.
- LP-300 is being tested alongside standard chemotherapy agents in patients who have relapsed after tyrosine kinase inhibitor therapy.
- Lantern’s AI-driven approach may help identify and accelerate development of therapies in underserved cancer markets.
- Additional trial data from Taiwan and the U.S. is expected later in Q3 2025.
Lantern Pharma (NASDAQ: LTRN), a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine oncology drug development, has completed targeted patient enrollment in Japan for its ongoing Phase 2 HARMONIC(TM) clinical trial evaluating investigational drug candidate LP-300 in never-smoker non-small cell lung cancer (“NSCLC”) patients (https://ibn.fm/JXFqG).
The company enrolled 10 patients across five sites in Japan, including the National Cancer Center in Tokyo, ahead of its internal timeline. The milestone underscores Lantern Pharma’s international strategy to focus on regions with a higher prevalence of never-smoker NSCLC cases, an under-addressed patient population with no approved treatments specifically targeting their form of lung cancer.
Lantern Pharma’s HARMONIC trial is evaluating LP-300 in combination with standard chemotherapy (carboplatin and pemetrexed) for patients who have previously relapsed after treatment with tyrosine kinase inhibitors (“TKIs”). The Japanese arm of the trial represents one part of a broader multinational study also enrolling patients in the United States and Taiwan.
Lantern Pharma CEO and President Panna Sharma described the enrollment success as a validation of the company’s focus on regions where never-smoker NSCLC is most prevalent. “Completing our targeted enrollment in Japan ahead of schedule demonstrates excellent execution of our international expansion strategy and validates our decision to focus on regions where never-smoker NSCLC has the highest prevalence,” said Sharma. “This achievement builds momentum as we continue enrollment in Taiwan and the United States, bringing us closer to generating the clinical data that could establish LP-300 as a treatment option for this underserved patient population with significant unmet medical need.”
In Japan, 33-40% of new NSCLC cases occur in never-smokers, a rate more than twice that of the U.S. or Europe, where the figure typically falls around 15%. In Taiwan, more than half of lung cancer cases are found in never-smokers. Lantern Pharma’s trial strategy is built around these regional disparities.
The HARMONIC trial is designed to enroll around 90 patients and includes overall survival (“OS”) and progression-free survival (“PFS”) as its primary endpoints. Initial results from a U.S. cohort showed an 86% clinical benefit rate and a 43% objective response rate among the first seven patients. One patient experienced a durable complete response in target cancer lesions, with survival now nearing two years (https://ibn.fm/5PJ3T).
LP-300, a disulfide small molecule, has a multimodal mechanism of action. It interacts with cell redox enzymes and modifies tyrosine kinase receptors, critical components in cancer cell growth and resistance pathways. The compound has already been tested in multiple Phase 1-3 trials involving over 1,000 subjects, with retrospective analyses suggesting a survival advantage in never-smoker lung adenocarcinoma patients.
No therapies are currently approved specifically for never-smoker NSCLC. This makes Lantern’s work in this space a potentially valuable asset in the oncology drug development market. The company estimates the global market opportunity for treating never-smoker NSCLC exceeds $4 billion annually.
The potential value is compounded by Lantern Pharma’s AI-driven drug development platform, RADR(R). The platform analyzes large volumes of oncology data, more than 100 billion data points and 200+ machine learning algorithms, to identify molecular targets, refine trial design, and reduce the time and cost of oncology drug development. The company’s pipeline includes other AI-discovered or AI-enhanced oncology candidates. In March 2024, Lantern dosed patients in a Phase 1a/1b trial for LP-284, an agent targeting relapsed or refractory non-Hodgkin’s lymphoma.
Lantern Pharma has signaled openness to partnership or licensing discussions for LP-300 to support commercialization across different geographies. The company expects to provide additional trial updates, including data from Taiwan and the U.S., before the end of the third quarter of 2025.
For more information, visit the company’s website at www.LanternPharma.com.
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