ML261

ML261 is an autologous, potency-enhanced chimeric antigen receptor (CAR) T-cell therapy targeting Delta-like ligand 3 (DLL3), a protein frequently overexpressed in small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs). Developed by Moonlight Bio, ML261 is engineered using the company's proprietary platform to express a CARD11-PIK3R3 fusion protein alongside the anti-DLL3 CAR. This fusion protein is designed to provide constitutive signaling that mimics natural T-cell activation pathways, thereby improving the expansion, persistence, and anti-tumor activity of the CAR T cells within the immunosuppressive tumor microenvironment. The therapy is currently being evaluated in the Phase 1 SPECTRAL-1 clinical trial for patients with relapsed or refractory SCLC and select high-grade NECs, including extrapulmonary, gastroenteropancreatic, and prostate neuroendocrine cancers.