FDA clears IND application for a phase 1 study of first-in-class CD3/EGFR bispecific antibody BC3448
“FDA cleared the Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States. BC3448 is being developed in solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC. In preclinical studies, BC3448 demonstrated antitumor activity in multiple tumor types with high EGFR expression, regardless of mutational status of EGFR, KRAS or BRAF, indicating the potential for BC3448 to be an effective therapy for EGFR-expressing tumors, including those resistant to EGFR-TKI and EGFR mAbs.”
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