On December 6, 2021 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the first patient has been enrolled on the Phase 2 study of OBI-999 (Press release, OBI Pharma, DEC 6, 2021, View Source [SID1234596935]).
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OBI-999 is a novel antibody drug conjugate (ADC) cancer therapy targeting cancer with overexpression of Globo H. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. The Phase 2 study enrolls Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors. The study will evaluate the safety and therapeutic activity of OBI-999.
OBI-999-001 study (ClinicalTrials.gov Identifier: NCT04084366) has been initiated in more than ten medical centers in the US and in Taiwan. OBI Pharma’s Chief Medical Officer, Tillman Pearce, M.D., noted, "this clinical trial enrolls late-stage cancer patients who lack effective therapeutic options. We look forward to validating OBI-999 as a safe and effective novel treatment for the cancer patients with high unmet medical needs."
Dr Pearce also noted, "the safety and tolerability of OBI-999 has been validated in the Phase I study. High potency across multiple xenograft models and the prescreening of a Globo H immunohistochemistry assay for selection of patients with high Globo H expression in the Phase II study support our enthusiasm for OBI-999."
Apostolia Tsimberidou, MD, PhD. noted, "The aberrant expression of the glycolipid Globo-H in epithelial tumors makes it an attractive target. We are excited to explore the ADC, OBI-999, that holds the promise to induce clinically meaningful responses."
OBI anticipates completing the enrollment of the Phase II study in the second half of 2023.
【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. OBI-999 is currently in a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) to test its safety and efficacy as an oncology ADC therapy. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung 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.