DALLAS– Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence (“A.I.”) and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the Food and Drug Administration (FDA) has cleared the Company to proceed with its Phase 2 clinical trial, Harmonic™, for its investigational new drug LP-300. The Harmonic™ trial will be a 90 patient, multi-center, two arm, open-label, and randomized clinical trial evaluating LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (NSCLC).
“The launch of the Harmonic™ trial is a major milestone for LP-300. Our team is looking forward to beginning patient enrollment during the third quarter,” said Panna Sharma, CEO and President of Lantern. “LP-300 is an innovative therapy that is being developed for never smokers with NSCLC, a unique and growing population of lung cancer patients whose cancer is genetically different from smokers with lung cancer. LP-300 will be delivered in combination with standard of care chemotherapy. Importantly, LP-300 has been well tolerated in prior clinical trials and has shown potential to protect against harmful effects of chemotherapy while also de-naturing many of the tyrosine kinase receptors through cysteine modification that are involved with NSCLC,” continued Sharma.
The Harmonic™ trial is a Phase 2 clinical trial that will assess 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 expects that initial patients will be enrolled into the Harmonic™ trial during the third quarter of 2022. Enrollment is expected to occur over the next 12 to 16 months across multiple sites in the US.
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. LP-300 has also exhibited chemoprotective properties that may reduce side effects from chemotherapy.
According to the American Cancer Society lung cancer is the second leading cause of cancer in the US. In 2021 there were an estimated 218,000 total patients diagnosed with lung cancer representing approximately a $11.5 billion market size. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate market size of $1.5 to 2.0 billion.
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 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.
