News | September 3, 2019

OBI Pharma Announces U.S. FDA Clearance Of IND Application For A Phase 1/2 Study Of Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

First Clinical Trial to test the Safety and Efficacy of based on an ADC (Antibody Drug Conjugate) targeting Globo H, a glycolipid antigen found on multiple tumor types

Taipei, Taiwan /PRNewswire/ - OBI Pharma, 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 OBI-999 to conduct a Phase 1/2 study of its antibody drug conjugate (ADC) cancer therapy targeting Globo H, a glycolipid antigen.

OBI plans to enroll patients with advanced solid tumors including pancreatic, gastric, colorectal and esophageal cancers. OBI Pharma's Chief Medical Advisor, Tillman Pearce, M.D. noted, "This clinical trial intends to verify the safety and preliminary efficacy profile of OBI-999, a novel first-in-class antibody-drug conjugate that selectively targets Globo H. We are delighted to conduct this first-in-human clinical trial at the University of Texas M.D. Anderson Cancer Center, one of America's leading academic oncology research institutions."

Michael Chang, Ph.D., OBI Pharma Chairman and CEO, added, "OBI Pharma is excited to commence the Phase 1/2 safety and efficacy study of OBI-999, our unique anti-Globo H ADC glycolipid cancer therapy. We strive to develop and validate our novel anti-Globo H immuno-oncology pipeline to fulfill unmet medical needs of cancer patients."

About OBI-999
OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. This Globo H targeting antibody, OBI-888, is currently in a Phase ½ clinical trial (ClinicalTrials.gov Identifier: NCT03573544) to test its safety and efficacy as an immune-oncology therapy. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, lung, gastric, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI Pharma owns global rights to OBI-999.

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.

http://www.obipharma.com/

SOURCE: OBI Pharma, Inc.

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