OBI Pharma Announces Initiation of a Phase 1/2 Study of Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999.

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
September 3, 2019
OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
December 26, 2019

TAIPEI, Taiwan, December 18, 2019 ─ OBI Pharma, a Taiwan biopharma company (TPEx: 4174), today announced the initiation of a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) of OBI-999, an antibody drug conjugate (ADC) targeting Globo H, a glycolipid antigen overexpressed in multiple tumor types. Patients with solid tumors including gastric, pancreatic, colorectal and esophageal cancer are planned to be enrolled. The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations.

Patients have initiated treatment in the first-in-human Phase 1/2 study of OBI-999-001 at the University of Texas MD Anderson Cancer Center, Houston, TX, with Dr. Apostolia M Tsimberidou as the Principal Investigator. These patients have been diagnosed with the per protocol tumor types, including pancreatic and colorectal, cancers of high unmet medical need. Treatment with OBI-999 is continuing with no observable safety concerns or trends to date.

Apostolia Tsimberidou, MD, PhD. noted,We are excited to treat the first patients with OBI-999, a novel first-in-class antibody-drug conjugate and with the unique potential that this drug brings to patients with multiple tumor types. The aberrant expression of the glycolipid Globo-H in epithelial tumors makes it an attractive target and this ADC holds the promise to induce clinically meaningful responses.”

Tillman Pearce, MD, CMO, OBI Pharma added, “The initiation of patient enrollment in this Phase 1/2 study is a milestone for OBI Pharma. High potency across multiple xenograft models and the availability of a Globo H immunohistochemistry assay for selection of patients with high Globo H expression in the phase 2 portion of the study support our enthusiasm for OBI-999.”

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 1/2 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.

COMPANY CONTACT:
Kevin Poulos
OBI Pharma USA, Inc.
+1 (858) 731-6706
kpoulos@obipharmausa.com