On March 28, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported the dosing of the first patient in the Phase 2 Harmonic clinical trial evaluating Lantern’s investigational new drug LP-300 in combination with chemotherapy for never smokers with advanced non-small cell lung cancer (NSCLC) (Press release, Lantern Pharma, MAR 28, 2023, View Source [SID1234629457]).
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"Never-smokers with non-small cell lung cancer face limited choices in therapy options after treatment with targeted therapies, and we believe there is a great opportunity to introduce a therapeutic regimen designed specifically for this subgroup of cancer patients," stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern Pharma’s VP of Clinical Development. "These patients show tremendous bravery and resolve in helping to establish signals of efficacy including potential increased survival in this Phase 2 trial that combines LP-300 with standard-of-care treatment. Our team continues to watch and monitor additional patients that are being screened and who, after guidance from their clinicians, may potentially enroll in the Harmonic trial," continued Dr. Ewesuedo.
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 smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3rd receiving chemotherapy alone. Lantern has activated 5 clinical trial sites, across 12 locations in the US including Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, Texas Oncology, and Cancer and Blood Specialty Clinic. Across the 5 Harmonic clinical trial sites, there is 1 dosed patient and 14 additional potential patients that have been pre-screened and are being monitored for possible enrollment. Multiple additional trial sites across the US are expected to be activated in the 1st half of 2023 and will bolster patient recruitment and enrollment.
In a previous multi-center Phase 3 clinical trial, a subset of never smoker 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. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.
About Lung Cancer in Never Smokers:
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.