On July 31, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported the successful completion of targeted enrollment for its Phase 2 HARMONIC clinical trial in Japan (Press release, Lantern Pharma, JUL 31, 2025, View Source [SID1234654696]). The company enrolled 10 patients ahead of schedule across five clinical sites in Japan, including the National Cancer Center Japan.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs). The successful Japanese enrollment validates Lantern’s strategic decision to expand the trial internationally to regions with significantly higher rates of never-smoker NSCLC patients such as Japan and Taiwan.
"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 Panna Sharma, President and CEO of Lantern Pharma. "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."
The completion of Japanese enrollment represents an important milestone in the global HARMONIC trial, which is designed to enroll approximately 90 patients across multiple regions. Japan’s notably higher rate of never-smoker NSCLC patients (33-40% of new cases) compared to Western populations (typically 15%) makes it a strategically important region for the trial. Similarly, Taiwan, where more than 50% of lung cancer cases occur in never-smokers, represents another key enrollment region.
The HARMONIC trial previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States. Notably, recent data revealed that one patient has achieved a durable complete response in target cancer lesions with survival continuing for nearly two years, demonstrating the potential for LP-300 to deliver meaningful long-term outcomes for never-smoker NSCLC patients.
Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics1, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients, highlighting the significant unmet medical need this population faces.
Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300’s commercial potential in multiple geographies. Lantern is scheduled to provide further clinical and outcome data from the HARMONIC trial later this quarter, with updates covering both Asian and U.S. patient cohorts.
About LP-300 LP-300 is a disulfide small molecule and investigational drug candidate with a multimodal mechanism of action directed toward tyrosine kinase receptors and cell redox enzymes. It modulates cellular redox in key signaling pathways in NSCLC and directly engages with TKI receptors via cysteine modification. LP-300 has been evaluated in multiple Phase 1, 2, and 3 clinical trials in over 1,000 subjects, with retrospective analysis showing significant survival benefit in never-smoker lung adenocarcinoma patients.
About the HARMONIC Trial The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone in never-smoker NSCLC patients who have relapsed following TKI treatment. The trial is expected to enroll approximately 90 patients across sites in the United States, Japan, and Taiwan. The primary endpoints are progression-free survival (PFS) and overall survival (OS). For more information about the trial, visit www.harmonictrial.com or clinicaltrials.gov (NCT05456256).