OBI Pharma gets USFDA clearance for OBI-999 to treat pancreatic cancer
New Delhi: OBI Pharma, a Taiwan biopharma company, recently 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 enrol patients with advanced solid tumours including pancreatic, gastric, colorectal and esophageal cancers.
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 (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.
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 fulfil unmet medical needs of cancer patients.”