On December 18, 2019 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported 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 (Press release, OBI Pharma, DEC 18, 2019, View Source [SID1234552488]). 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.
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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.