NextCure, Inc.

We are a clinical-stage biopharmaceutical company focused on developing innovative medicines for cancer patients who do not respond to or experience disease progression on current therapies. We achieve this through targeted therapies, including antibody-drug conjugates (ADCs). An ADC combines a monoclonal antibody with a cytotoxic drug using a chemical linker. Our focus leverages our understanding of biological pathways, biomarkers, cell interactions within the tumor microenvironment, and their role in biological responses. Our product candidate, SIM0505, is a novel ADC candidate developed by Simcere Zaiming Pharmaceutical Co., Ltd. (Zaiming). We hold an exclusive, worldwide license (excluding China, Hong Kong, Macau, and Taiwan, referred to as the "Zaiming Territory") to develop, manufacture, and commercialize Zaiming's clinical-stage ADC candidate, SIM0505, and related compounds (the "Zaiming Products"). We also have a non-exclusive, worldwide license (excluding the Zaiming Territory) to use Zaiming's ADC platform technology to develop ADCs based on our proprietary antibodies for an additional novel target (the "NextCure Products"). Zaiming retains exclusive rights for the Zaiming Products and any NextCure Products in the Zaiming Territory. SIM0505 targets cadherin-6 (CDH6), an anti-tumor target, using a unique binding epitope designed for increased tumor binding. It incorporates Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity and fast systemic clearance to expand the therapeutic window. Preclinical studies have shown robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. Zaiming is currently conducting Phase 1 dose escalation studies in China for SIM0505 to treat solid tumors, including ovarian, endometrial, non-small cell lung, and renal cancers. In December 2024, Zaiming received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) for a Phase 1 clinical trial for treating multiple cancers.