OBI Pharma, a Taiwan biopharma company (TPEx: 4174), today announced that the first patient has been enrolled on the Phase 2 study of OBI-999.
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.
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.
【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, SSEA-3 and SSEA-4), AKR1C3, and other promising targets.
The company’s novel first-in-class immuno-oncology portfolio against Globo H includes: Adagloxad Simolenin (formerly OBI-822) and OBI-833, a Globo H 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.
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.
OBI Pharma USA, Inc.
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