OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study

OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2.

The antibody molecules utilized in the development of this ADC were discovered and developed using Biosion’s proprietary SynTracer high-throughput antibody endocytosis screening platform and were licensed to OBI Pharma in December 2021. OBI-992 (BSI-992) incorporates a differentiated hydrophilic, enzyme-cleavable linker that maintains stability in circulation but releases the cytotoxic payload within tumor cells. The therapy has shown remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. While Biosion discovered and developed the anti-TROP-2 targeting antibody, OBI Pharma holds the ex-China commercial rights for OBI-992 (BSI-992).- Flcube.com

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