Lantern Pharma gets FDA nod for Harmonic phase 2 clinical trial of LP-300
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with its Harmonic phase 2 clinical trial of LP-300, its investigational new drug in never smokers with non-small cell lung cancer (NSCLC).
Harmonic will involve 90 patients in a multi-center, two arm, open-label, and randomized study for assessing LP-300 in combination with chemotherapy made up of pemetrexed and carboplatin.
Lantern Pharma expects to enroll initial patients into the Harmonic phase 2 clinical trial of LP-300 during Q3 2022. The clinical-stage oncology-focused biopharma company said that enrolment is likely to take place during the next 12 to 16 months across various sites in the US.
Panna Sharma — Lantern Pharma CEO and President said: “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.”