BioCity Receives FDA Approval for Phase 1 Trials of Novel GPC3-Targeting ADC, BC2027

BioCity Biopharma has received approval from the FDA to commence a Phase 1 clinical trial for BC2027, marking it as the company's second innovative antibody drug conjugate (ADC) to reach this stage. The drug is designed to target Glypican 3 (GPC3), a protein that is prevalent on the surface of cancer cells, particularly in hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. GPC3 is also overexpressed in certain lung and esophageal cancers, making it a strategic target for therapeutic intervention. 

BC2027 exhibits a high binding affinity for GPC3, facilitating its internalization into cancer cells where it delivers a potent cytotoxic agent. The drug not only eliminates the cancer cells it directly enters but also has an indirect effect on neighboring cancer cells, a phenomenon known as the "bystander effect." Preclinical trials have shown BC2027 to be safe and well-tolerated, with over 90% tumor growth inhibition in some cases, highlighting its potential as a novel cancer treatment. 

Dr. Yong Jiang Hei, CEO of BioCity, emphasized the growing issue of drug resistance in cancer treatment and the company's commitment to developing next-generation therapies to combat this challenge. He highlighted the development of novel ADCs as a key strategy to address inherent and secondary drug resistance in HCC and other cancers. With two pioneering ADCs in clinical development, BioCity is positioned to advance these therapies to address unmet medical needs and improve patient outcomes globally. HCC is a significant global health concern, with nearly 860,000 new cases and approximately 750,000 deaths reported annually. GPC3's high expression in over 70% of HCC cases, correlating with disease progression, underscores its importance as a therapeutic target. 

BioCity, established in 2017, is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer and autoimmune disorders, including chronic kidney disease. The company's pipeline includes over 10 drug candidates, ranging from small molecules to monoclonal and bispecific antibodies, as well as ADCs. Currently, BioCity has six oncology assets in Phase 1 clinical development, targeting various pathways and mechanisms within the cancer treatment landscape. An endothelin A receptor antagonist for chronic kidney disease is also in Phase 2 clinical development.

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