NEW YORK – Lantern Pharma on Tuesday said it received feedback from the US Food and Drug Administration that it will use to submit an investigational new drug application for LP-184. The company further plans to begin studying the drug in a Phase I trial of patients with solid tumors, including cancers with DNA damage repair deficiency, in the second quarter of 2023.
The Dallas-based company requested a pre-IND meeting with the agency at the end of 2022 to gather feedback on its plans for LP-184. Based on the agency's input, Lantern is optimistic it will be able to start a Phase I trial for LP-184 next quarter and begin enrolling patients with pancreatic cancer, malignant gliomas, and select solid tumors with DNA damage repair deficiency.
LP-184 is a small molecule drug that is activated in tumors that overexpress the oxidoreductase enzyme prostaglandin reductase 1 (PTGR1). According to Lantern, LP-184 induces DNA damage that interferes with two DNA repair mechanisms — transcription-coupled nucleotide excision repair and homologous recombination — leading to synthetic lethality in tumors reliant on each of those pathways.
Lantern is investigating LP-184 in a range of solid and central nervous system tumors in partnership with Fox Chase Cancer Center, Champions Oncology, Johns Hopkins School of Medicine, and the Greehey Children's Cancer Research Institute at the University of Texas Health Science Center, San Antonio. Preclinical studies have confirmed LP-184's synthetic lethality mechanism and shown favorable blood-brain permeability and preliminary efficacy for CNS cancers.
Other cancer drugs in Lantern's development pipeline include LP-300 and LP-100. The former is undergoing a Phase II trial in patients with biomarker-defined advanced non-small cell lung cancer. Lantern is developing LP-100 as a treatment for metastatic castration-resistant prostate cancer and using a genomic signature to identify best responders in a Phase II trial in Denmark. The company is also working with the Danish Cancer Society and Research Center to study LP-100 and LP-184 against tumors with nucleotide excision repair deficiencies.