NEW YORK – Lantern Pharma said on Monday that it will begin a Phase IA trial of the small molecule drug LP-184 in patients with certain solid tumors including those with DNA damage response (DDR) deficiencies.
The US Food and Drug Administration cleared Lantern's investigational new drug application, allowing it to begin the Phase IA trial, in which the firm will study the safety and tolerability, and establish a maximum tolerated dose of LP-184 in patients with advanced pancreatic cancer, recurrent high-grade gliomas or glioblastoma, metastatic brain and central nervous system cancers, and other solid tumors with DDR deficiencies.
Dallas-based Lantern developed LP-184 using its RADR machine learning platform to identify the indications in which to develop the drug and advance biomarker signatures for patient selection in clinical trials.
Beyond its potential as a single agent, Lantern says LP-184 efficacy may be enhanced when combined with other treatments, including PARP inhibitors or radiation.
Lantern anticipates that it will complete the Phase IA trial by the first half of 2024. After that, the firm will advance LP-184 into other solid tumor trials. Lantern subsidiary Starlight Therapeutics will advance LP-184 in brain and central nervous system indications but will call the drug STAR-001. Lantern estimates up to a $7 billion market for the drug in solid tumors and a $6 billion market in central nervous system cancers.
"We believe LP-184 has blockbuster potential for patients with multiple types of advanced solid tumors and central nervous system cancers, many of which have no or limited effective therapeutic options," Lantern President and CEO Panna Sharma said in a statement.