bdc-1001

BDC-1001 is an immune-stimulating antibody conjugate (ISAC) designed to target HER2-expressing tumors. It consists of a biosimilar of trastuzumab (Herceptin) conjugated via a non-cleavable linker to a proprietary toll-like receptor 7/8 (TLR7/8) agonist. The drug is engineered to trigger local activation of the innate immune system within the tumor microenvironment, leading to both innate and adaptive anti-tumor immune responses. BDC-1001 has demonstrated clinical activity and tolerability in phase 1/2 studies as monotherapy and in combination with checkpoint inhibitors such as nivolumab or pertuzumab, particularly in patients with HER2-positive solid tumors who have progressed after standard therapies. The agent has received FDA orphan drug designation for gastric and gastroesophageal junction cancers[2][5][6][7].

Other names

trastuzumab imbotolimod