OBI Pharma, Inc., is a Taiwan biopharmaceutical company that was established in 2002. It is publicly-listed on the Taipei Exchange (TPex ticker: 4174). OBI’s mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA3, SSEA4), AKR1C3, and other promising targets. Globo Series and AKR1C3 are highly expressed in cancers of unmet need including Breast, Ovarian, Gastric, Lung, Liver Prostate and Esophageal.
The company’s novel first-in-class immuno-oncology portfolio against Globo Series includes: Adagloxad Simolenin (formerly OBI-822; Globo H cancer vaccine), OBI-888 (Globo H mAb), OBI-999 (Globo H ADC), OBI-898 (SSEA4 mAb) and OBI-866 (SSEA4 cancer vaccine). Adagloxad Simolenin is a novel active Immuno-Oncology (IO) therapeutic vaccine for the treatment of epithelial-derived cancers, such as breast, ovarian, lung, prostate, colon, gastric, and pancreatic cancer. OBI has completed a Phase II multinational randomized control trial for Metastatic Breast Cancer, and commenced a Global P3 TNBC (Triple–negative Breast Cancer) trial in 2H, 2018. OBI-888 is a novel first-in-class monoclonal antibody selectively targeting Globo H. OBI has obtained U.S. FDA clearance for a Phase 1 Study of OBI-888 in January 2018, and commenced enrollment of patients with locally advanced or metastatic solid tumors of all types. OBI has completed preliminary pharmacological studies for OBI-999, OBI-898 and OBI-866. Preclinical preparation for human clinical trials are underway.
The company’s novel first-in-class AKR1C3 therapy is OBI-3424 (small-molecule prodrug) that selectively releases a potent DNA alkylating agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. OBI has obtained U.S. FDA clearance for a Phase 1 Study of OBI-3424 in April 2018, and has commenced enrollment in patients with local solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC).