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Cstone Pharmaceuticals has announced the U.S. Food and Drug Administration’s (FDA) STUDY MAY PROCEED (SMP) letter and investigational new drug (IND) application approval for CS5001, a potential antibody-drug conjugate (ADC) to target receptor tyrosine kinase-like orphan receptor 1 (ROR1). ROR1 is an oncofetal protein with low or no expression in adult tissues, but with high expression in a number of cancers, including leukemias, non-Hodgkin lymphoma, breast cancer, lung cancer, and ovarian cancer, making it an ideal target for an ADC. CS5001 is a clinical-stage ADC that targets ROR1 using multiple differentiated features, including proprietary site-specific conjugation, tumor-selective cleavable linker and pyrrolobenzodiazepine (PBD) prodrug technology. After reaching the tumor, the linker and prodrug are cleaved to release to the PBD toxin, resulting in lethal DNA cross-links within cancer cells. CStone Pharmaceuticals is a leading biopharmaceutical company that focuses on the research, development, and commercialization of immuno-oncology therapies and precision medicines.

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