Tuesday, 20 August 2019

OBI Pharma receives FDA nod for Phase I study of its cancer drug

18 January 2018 | News

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 epithelial cancers

Taiwan-based biopharma company OBI Pharma announced that it has received the US FDA nod for an investigational new drug (IND) application for a Phase 1 study of a monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen (OBI-888).

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 epithelial cancers. This Globo H targeting antibody has been shown to induce tumor-killing via antibody dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP), and complement dependent cytotoxicity (CDC).

OBI Pharma's Chief Science Officer and Acting Chief Medical Officer, Dr. Tony Yu, noted, "This clinical trial intends to verify the safety and preliminary activity profile of OBI-888, a monoclonal antibody that targets Globo H selectively."

Amy Huang, General Manager of OBI Pharma, added, "We embark on a new opportunity, based on the innovation OBI has developed from its unique glycolipid cancer immunotherapy pipeline. With this trial, OBI is taking a first-step towards testing the safety and initial efficacy of a new class of monoclonal antibodies. We are excited to bring forth new and effective tools in the fight against cancer."

OBI Pharma, was established in 2002and works towards developing novel cancer therapies for unmet medical needs against cancer targets such as Globo Series. The company's novel first-in-class immuno-oncology portfolio against Globo Series includes: Adagloxad Simolenin (formerly OBI-822), a Globo Series active immunotherapy vaccine; OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC).  The company's novel first-in-class AKR1C3 targeted 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. 

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