Lantern Pharma's New Phase 2 Clinical Trial –Harmonic™ — Approved for Launch by the FDA

When most people think of lung cancer, they often picture a smoker.

But CDC data indicates that between 10% and 20% of new lung cancer diagnoses in the United States each year are in patients who’ve smoked fewer than 100 cigarettes in their lifetime.

When people who have never smoked get non-small cell lung cancer (NSCLC), the cancer behaves differently than lung cancer in smokers - so much so, that researchers are considering classifying it as a separate entity. While early-stage survival rates are higher for never smokers, they may be more likely to relapse, and their mortality rates can be even higher in more advanced stages relative to smokers.

To help fight this aggressive cancer that currently has limited treatment options, Lantern Pharma Inc. LTRN has launched the Harmonic™ trial, a Phase 2 clinical trial of its late-stage investigational drug candidate LP-300. 

The Harmonic™ Trial To Target Advanced NSCLC In NonSmokers

The Harmonic™ trial is a Phase 2, 90 patient, two-arm, randomized, and open label clinical trial that Lantern states will study the potential of LP-300, the company’s late-stage investigational new drug, in combination with chemotherapy as a treatment for never-smoker patients with advanced NSCLC. During the Phase 2 clinical trial, Lantern expects that 60 patients will receive LP-300 with chemotherapy, and 30 patients will receive chemotherapy alone, which is the standard of care for this patient population

LP-300, in combination with chemotherapy, is being developed as a treatment for never-smoker patients with advanced NSCLC. With previous clinical trials already completed, the small molecule has reportedly shown promise as part of a combination treatment with chemotherapy, and has been shown to increase patient overall and two-year survival by 91% and 125%. Additionally, LP-300 was well tolerated in about 1,000 people to date.

With plans to dose the first patients this quarter (Q3, 2022), the trial is targeted to enroll patients across 15-20 clinical sites in the United States. Lantern is optimistic that the new trial will yield promising results as the drug candidate has already shown promise in a cohort of never-smokers in previous studies. 

LP-300 As Chemotherapy’s Greatest Ally?

Lantern reports that LP-300 uses several mechanisms of action to fight NSCLC in never-smokers. First, by modifying cysteines of proteins, including EGFR, ALK, ROS, and MET, that are involved with NSCLC in never smokers and inactivating them. In addition to modifying protein activity, preclinical and clinical studies have shown LP-300 can also act as chemoprotective and chemosensitizing agent — meaning it helps protect the body from the harsh side effects of chemotherapy while making the cancer more vulnerable to the chemotherapy treatment. These mechanisms can help weaken and stop the spread of cancer cells while also reducing some of the toxicities associated with chemo.

Lantern hopes to add additional positive data to move LP-300 closer to approval by the Food and Drug Administration, ideally bringing the drug closer to becoming an FDA-approved therapy for the growing number of never smokers with NSCLC.

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