Iryna Drozd
- Apollomics said on Tuesday that the U.S. Food and Drug Administration (FDA) in August granted orphan drug designation to the company's vebreltinib (APL-101) to treat patients with non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations.
- Apollomics is going public on Nasdaq via a business combination with SPAC Maxpro Capital Acquisition (NASDAQ:JMAC). The transaction expected to close in Q1 2023 and Apollomics is expected to trade on Nasdaq under the symbol APLM.
- Apollomics is currently evaluating vebreltinib in a global phase 2 trial, dubbed SPARTA, in patients with NSCLC and other solid tumors with MET genomic dysregulation.
- The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
- "While NSCLC is the most common type of lung cancer, a subset of patients will have MET genomic dysregulations in their tumors which make them more resistant to treatment, presenting an unmet medical need," said Guo-Liang Yu, co-founder, chairman and CEO, Apollomics.