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DALLAS - Lantern Pharma Inc. (NASDAQ:LTRN), a clinical-stage biotech company currently trading at $4.01, has completed patient enrollment for its Phase 2 HARMONIC clinical trial in Japan ahead of schedule, the company announced Thursday in a press release. According to InvestingPro analysis, the company maintains a strong liquidity position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn as it advances its clinical programs.
The trial is evaluating LP-300 in combination with standard chemotherapy for never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after treatment with tyrosine kinase inhibitors. Ten patients were enrolled across five Japanese clinical sites, including the National Cancer Center Japan.
Japan represents a strategically important region for the study due to its higher prevalence of never-smoker NSCLC patients, with 35-40% of new cases occurring in never-smokers compared to approximately 15% in Western populations.
The HARMONIC trial aims to enroll approximately 90 patients globally across the United States, Japan, and Taiwan. Earlier results from the initial safety cohort showed an 86% clinical benefit rate and 43% objective response rate among the first seven U.S. patients, according to the company.
Never-smoker NSCLC, which has distinct clinical and genomic characteristics from smoker-related lung cancer, currently has no specifically approved therapies despite representing a significant patient population.
"This achievement builds momentum as we continue enrollment in Taiwan and the United States," said Panna Sharma, President and CEO of Lantern Pharma, in the statement.
The company expects to provide additional clinical data and updates from both Asian and U.S. patient cohorts by the end of the third quarter of 2025.
LP-300 is a small molecule drug candidate that has been previously evaluated in multiple clinical trials involving over 1,000 subjects. The current Phase 2 trial’s primary endpoints are progression-free survival and overall survival.
In other recent news, Lantern Pharma Inc. announced that a patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma achieved a complete metabolic response in a Phase 1 clinical trial of its experimental drug LP-284. The patient had previously undergone three unsuccessful treatment regimens, including standard chemotherapy and CAR-T cell therapy, before responding positively to LP-284. Lantern Pharma also revealed promising preclinical data for its drug candidate LP-184, which targets atypical teratoid rhabdoid tumors, a rare pediatric brain cancer. The data, presented at a pediatric neuro-oncology conference, indicated significant survival improvements in mouse models, supporting the drug’s Rare Pediatric Disease Designation by the FDA.
Additionally, Lantern Pharma launched a new AI module within its RADR platform to predict the efficacy of cancer treatment combinations involving DNA-damaging agents. This development aims to contribute to a cancer therapy market expected to surpass $50 billion by 2030. In corporate developments, Lantern Pharma appointed Lee T. Schalop, M.D., a biotech executive with extensive experience, to its board of directors. Schalop co-founded Oncoceutics, Inc., which was acquired by Chimerix Inc. for $450 million in 2021. These recent developments highlight Lantern Pharma’s ongoing efforts in drug development and corporate governance.
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