OBI Pharma Announces FDA Clearance Of IND Application For A Phase 1 Study Of A Monoclonal Antibody Cancer Immunotherapy (OBI-888).

First Clinical Trial to Test the Safety and Preliminary Activity of Passive Immunotherapy based on a Monoclonal Antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.

TAIPEI, Taiwan, Jan. 17, 2018 /PRNewswire/ -- OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared 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 plans to enroll patients with locally advanced or metastatic solid tumors of all types. Building off the findings of the Phase 2 trial for its flagship active immuno-oncology therapy, Adagloxad Simolenin (OBI-822), 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."

About 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-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated, and no adverse effect was found in all the doses tested. OBI Pharma owns global rights to OBI-888.

About OBI Pharma

OBI Pharma, Inc., is a Taiwan biopharmaceutical company that was established in 2002. Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H), AKR1C3, and other promising targets.

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. Additional information can be found at www.obipharma.com.

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma's reports and presentations, including OBI Pharma's filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:
Gus Adapon
OBI Pharma, Inc.
+886 (2) 2786-6589
[email protected]