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FDA grants Orphan Drug Designation for gastric cancer antibody-drug OBI-999

Thu, 01/23/2020 - 16:47
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The US FDA has granted Orphan Drug Designation for OBI Pharma’s OBI-999, a first-in-class antibody drug conjugate targeting Globo H - a glycolipid antigen, for the treatment of gastric cancer.  A Phase 1/2 clinical trial of OBI-999 has commenced enrolment at the University of Texas MD Anderson Cancer Center, with Dr Apostolia M Tsimberidou as the Principal Investigator, in patients with locally advanced or metastatic solid tumours, including gastric, pancreatic, colorectal and oesophageal cancers. The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations.

"Advanced gastric cancer is an orphan disease where targeted therapies are lacking for the majority of patients. OBI-999 is an antibody-drug conjugate therapeutic targeting the cancer-associated glycolipid antigen, Globo H. OBI-999 incorporates a validated payload, MMAE, with a proprietary linker technology,” said Dr Tillman Pearce, OBI Pharma. “It has demonstrated high effectiveness in xenograft models of metastatic gastric cancer that overexpress Globo H. Clinical development of this agent will be guided by evaluation of patients based on a validated Globo H immunohistochemistry assay, which will allow selection of patients whose tumours overexpress this tumour antigen for clinical investigation."

OBI-999 has 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.