Lantern Pharma Inc. announced that - the company has received regulatory approval to expand its Harmonic trial, a Phase 2 clinical study evaluating LP-300 in non-small cell lung cancer (NSCLC) in never-sm smokers in both Japan and Taiwan. The approval to proceed with the Phase 2 clinical trials in Japan and Taiwan are expected to accelerate the collection of patient and response data needed for the next-stage of evaluation and development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy Additionally, it may also bring a needed therapeutic option for LCINS diagnosed patients in Japan and Taiwan, where one-third of all lung cancer diagnoses are made among those who have never smoked. Finally, Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets.

The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern's investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smokers patients with advanced NSCLC. In a previous multi-center Phase 3 clinical trial, a subset of never smokers NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.

NSCLC presents differently in never smokers, which are defined by the CDC as a person who has smoked 100 cigarettes or less in their life, compared to smokers. These differences are believed to be due to a higher percentage of genetic mutations in a family of cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth.

LP-300?s intended mechanism is to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread. According to the American Cancer Society, lung cancer is the second leading cause of cancer in the US, with over 200,000 patients diagnosed annually. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate annual market potential of $1.5 to $2.0 billion.