Innovation Group: Osemitamab (TST001), a new drug targeting Claudin18.2 antibody for the treatment of pancreatic cancer, has been granted orphan drug status by the FDA

Innovation Group (06628.HK) announced that Osemitamab(TST001), a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced ADCC activity, has been granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This is the second orphan drug designation for Osemitamab(TST001) after it received FDA orphan drug designation for the treatment of gastric cancer and gastroesophageal junction cancer in 2021.

OrphanDrug are drugs that are designed to prevent, treat, and diagnose rare diseases. The orphan drug designation granted by the FDA is applicable to drugs and biologics with rare diseases that affect less than 200,000 people in the United States every year. The approved drugs have the opportunity to enjoy tax incentives in the United States and a seven-year period of market exclusivity.

Pancreatic cancer is one of the most challenging cancers to treat because it is often diagnosed late and often responds poorly to existing therapies. The 5-year survival rate after diagnosis is about 10%, and the median overall survival for patients with advanced or metastatic pancreatic cancer is hardly more than 9 months. In 2022, about 62,200 people will be diagnosed with pancreatic cancer and about 50,000 will die from the disease, according to the National Institutes of Health.

Last year, the company presented clinical data on Osemitamab (TST001) for pancreatic cancer at the 2022 International Congress on Gastric Cancer (IGCC), showing persistent partial responses in pancreatic cancer patients with low Claudin18.2 expression who received Osemitamab (TST001) as monotherapy. The patient developed disease progression despite multiple previous chemotherapy treatments. In preclinical studies, Osemitamab(TST001) demonstrated excellent antitumor activity in pancreatic cancer tumor models expressing Claudin18.2, independent of Kras mutation status.

Dr.Caroline Germa

Executive Vice President, Chief Medical Officer, Innovation Group

"We are currently evaluating the efficacy of Osemitamab (TST001) in the treatment of different tumors expressing Claudin18.2. Osemitamab (TST001) is believed to have the transformative potential for advanced pancreatic adenocarcinoma that lacks effective treatment options. We look forward to continuing to advance clinical studies in this indication for pancreatic cancer."

About Osemitamab(TST001)

Osemitamab(TST001) is a high-affinity humanized monoclonal antibody targeting Claudin18.2 with enhanced antitumor-dependent cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity, which demonstrated strong antitumor activity in xenograft trials. Osemitamab(TST001) is the second most advanced Claudin18.2 targeted antibody drug to be developed worldwide by the Company through its Immune Tolerance Breakthrough (IMTB) technology platform. Osemitamab(TST001) kills tumor cells expressing Claudin18.2 through ADCC and CDC mechanisms. Using advanced bioprocessing techniques, the fucose content of Osemitamab(TST001) was significantly reduced during production, further enhancing the NK cell-mediated ADCC activity of Osemitamab(TST001). Both China and the United States have been conducting Osemitamab (TST001) clinical trial (NCT04396821, NCT04495296 / CTR20201281). The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Osemitamab(TST001) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ).