NEW YORK – Lantern Pharma said this week that the US Food and Drug Administration has granted orphan drug designation to the firm's next-generation DNA-damaging alkylating agent LP-184 for glioblastoma multiforme and other malignant glioma patients. LP-184 is designed to damage DNA in cancer cells that overexpress certain biomarkers or DNA repair pathway mutations. The Dallas-based drugmaker said LP-184 may be used to target advanced, temozolomide-resistant glioblastomas that have unmethylated MGMT or EGFR aberrations. The FDA previously granted orphan drug status to the same drug for pancreatic cancer.
TCR2 Therapeutics said this week that the US Food and Drug Administration has granted orphan drug designation to the firm's investigational T-cell therapy gavocabtagene autoleucel for cholangiocarcinoma patients. The Cambridge, Massachusetts-based firm is evaluating gavo-cel in a Phase I/II clinical trial in patients with previously treated, mesothelin-expressing solid tumors, and plans to present data from the trial's dose-escalation portion in mesothelioma, ovarian cancer, and cholangiocarcinoma during the upcoming European Society for Medical Oncology conference this month.
Huyabio this week filed an investigational new drug application with the US Food and Drug Administration for its SHP2 inhibitor HBI-2376. GenHouse Pharmaceutical, which licensed HBI-2376 in China from Huyabio last year, also filed an IND with the Chinese Center for Drug Excellence. Huybio has studied HBI-2376 in preclinical models of multiple tumor types that are dependent on the MAPK pathway. The company has found the drug is effective in tumor models as a monotherapy or in combination with other small molecule inhibitors or checkpoint inhibitors.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.