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Lantern Pharma Gets FDA Nod to Begin Phase II Trial of LP-300 in Biomarker-Defined NSCLC

NEW YORK – Lantern Pharma on Thursday said it has received permission from the US Food and Drug Administration to begin a Phase II trial of its investigational drug LP-300 plus chemotherapy in patients with biomarker-defined advanced non-small cell lung cancer.

The trial, called Harmonic, is slated to begin enrollment in the third quarter and will involve 90 patients who will receive either LP-300 with chemo or chemo alone. Eligible NSCLC patients must be never smokers, have prior treatment with tyrosine kinase inhibitors, and harbor alterations in MET exon 14, ALK, EGFR, or NTRK.

LP-300 is a cysteine-modifying agent that can modulate multiple cellular pathways simultaneously including ALK, EGFR, MET, and ROS1. The drug has also shown in previous studies to reduce toxicities associated with chemo and help sensitize patients to chemo treatment.

"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," Lantern CEO Panna Sharma said in a statement. "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."

Dallas-based Lantern acquired LP-300, previously named Tavocept, from BioNumerik Pharmaceuticals in a 2018 deal. The drug failed to meet its primary endpoint in a Phase III study in an all-comer population of advanced NSCLC patients, but it showed activity in a smaller subset of patients with certain genomic mutations.

After Lantern acquired LP-300, it used its RADR machine learning platform to identify patients most likely to benefit from treatment with the drug.