OBI-992 has been approved by US FDA for Orphan Drug Designation for the treatment of gastric cancer

OBI Pharma, a clinical-stage oncology company (4174.TWO), received the notification letter today from US FDA, stating that the request for Orphan Drug Designation of OBI-992 TROP2 ADC for the treatment of gastric cancer, including gastroesophageal junction cancer, has been approved. Heidi Wang, Ph.D, OBI Pharma’s Chief Executive Officer pointed out, the U.S. FDA grants Orphan Drug Designation to drugs that have the potential to treat rare diseases to encourage the industry to develop new treatment options for these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 200,000 patients. After granting Orphan Drug Designation, the US FDA will offer companies or drug developers incentives such as more assistance and marketing exclusivity.【FDA website：https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1018424】 OBI-992 is an ADC independently developed by OBI and targeting TROP2. In June, OBI launched a phase I/II clinical trial in the United States, recruiting patients with advanced solid tumors, including gastric cancer (GC) and other potential cancers. The objectives of the trial are to verify the safety, pharmacokinetics, and preliminary efficacy profile of OBI-992 in these patient populations. OBI Pharma’s Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer. “We look forward to investigating this potential best-in-class TROP2 ADC in the clinic.” Since December 2021, OBI has been granted by Biosion, Inc. an exclusive license to a TROP2 targeting antibody amino acid sequence in all jurisdictions except Mainland China, Hong Kong and Macau. Biosion holds exclusive rights to that antibody sequence in Mainland China, Hong Kong and Macau. OBI holds commercial rights to OBI-992 and OBI-902 in all jurisdictions except Mainland China, Hong Kong and Macau, while Biosion holds commercial rights to OBI-992 and OBI-902 in Mainland China, Hong Kong and Macau.

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