The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for patients with advanced, recurrent, or metastatic HER2 expressing (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+) endometrial cancer, particularly during or following treatment with immune checkpoint inhibitors (ICIs).
DB-1303, a third-generation HER2 ADC, is composed of an anti-HER2 monoclonal antibody, an enzyme-cleavable peptide linker, and a proprietary topoisomerase I inhibitor known as P1003. Early results from a Phase I/IIa study have demonstrated promising anti-tumor activity and favorable tolerability for DB-1303. In April 2023, BioNTech entered into a licensing agreement valued at $1.67 billion with Duality Bio, securing global rights to DB-1303, along with another ADC product, DB-1311, excluding rights for mainland China, Hong Kong, and Macau.- Flcube.com
