Apollomics Inc. (NASDAQ:JMAC), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination-oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to vebreltinib (APL-101) for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations. The FDA granted the Orphan Drug Designation in August.

"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, PhD, co-founder, Chairman and Chief Executive Officer of Apollomics. "We are pleased to have received the Orphan Drug Designation for vebreltinib, as patients need new and better treatment options. Through genomic testing, we can identify patients who will benefit most from a targeted treatment like vebreltinib. Orphan Drug Designation brings significant developmental benefits to the vebreltinib program, most notably seven-year market exclusivity upon its approval."

Apollomics' ongoing global Phase 2 SPARTA study is evaluating vebreltinib in patients with NSCLC and other solid tumors with MET genomic dysregulation.

Dysregulation of the c-MET tyrosine kinase receptor is implicated in the development of tumor malignancy and can arise through several mechanisms, including gene fusion and amplification, overexpression of the receptor and/or its ligand hepatocyte growth factor (HGF), and the acquisition of activating mutations. One type of the activating mutations cause exon 14 to be skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping occurs in approximately 3-4% of NSCLC and has been demonstrated to be an oncogenic driver. MET amplification, another potential oncogenic driver, occurs in ~3% of newly diagnosed NSCLC, as well as in some NSCLC patients treated with targeted TKI therapy, such as EGFR inhibitors, who become treatment resistant.

The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits including assistance in the drug development process, tax credits for clinical costs, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, and seven years of post-approval exclusivity.

As previously announced on Sept. 14, 2022, Apollomics and Maxpro Capital Acquisition Corp. ("Maxpro") (NASDAQ:JMAC, JMACU, JMACW))))), announced a definitive agreement for a business combination (the "Transaction" or the "Business Combination") that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market ("Nasdaq"). The Business Combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol "APLM."