Lantern Pharma has announced that its investigational drug candidate, LP-184, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of triple-negative breast cancer (TNBC). This marks the second Fast Track designation for LP-184 in 2024, following its designation for glioblastoma in October.
LP-184 is currently being evaluated in a Phase 1A clinical trial designed to assess its safety and tolerability in patients with a range of solid tumors. The trial aims to determine the appropriate dosage and identify potential adverse effects of the drug.
TNBC is an aggressive form of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 protein, making it difficult to treat with traditional hormone therapies or HER2-targeted drugs. The prognosis for patients with TNBC is generally poorer compared to other types of breast cancer, underscoring the urgent need for new and effective treatment options.
The Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. Drugs with Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the development plan and data needed to support approval, as well as priority review if relevant criteria are met.
Lantern Pharma, a Dallas-based company focused on leveraging artificial intelligence (AI) in drug development, saw its shares rise following the announcement. The company believes that LP-184 has the potential to address significant unmet needs in the treatment of various cancers, including TNBC and glioblastoma.
The Phase 1A trial is ongoing, and further results will be crucial in determining the future development path of LP-184. The company is optimistic about the potential of LP-184 to provide a new treatment option for patients with aggressive cancers.
