BDC-1001 + nivolumab

BDC-1001 + nivolumab is a combination therapy consisting of an immune-stimulating antibody conjugate (ISAC) and an immune checkpoint inhibitor. BDC-1001 is a HER2-targeted ISAC designed to trigger local activation of the innate immune system and generate a durable tumor-targeted adaptive immune response. It incorporates a trastuzumab biosimilar (EG12014) conjugated to a proprietary TLR7/8 agonist using a non-cleavable linker and a cell membrane-impermeable payload. Nivolumab (Opdivo) is a PD-1 inhibitor that helps prevent cancer cells from hiding from the immune system. The combination has shown promising clinical activity including partial responses, tumor shrinkage, and long-term stable disease across multiple types of HER2-expressing solid tumors in clinical trials.