Product Development

Research and Translation
Harnessing an individual’s own immune system is emerging as a key strategy in disease treatment. Cancer and other diseased cells have developed sophisticated mechanisms to evade or modulate immunological responses.  NextCure has developed a large repertoire of function-based screening and translational methods to develop therapeutics that improve immune function.  This includes overcoming resistance and lack of responses to current immunotherapies.

Using our multi-faceted functional approach, primary human cells and animal models, we are identifying positive and negative regulators of T cells, NK cells, macrophages and myeloid-derived suppressor cells.  Our approach streamlines target validation and IND enabling studies including pharmacology and toxicology, PK/PD and ADA evaluation, tissue cross reactivity assessment, and assay development for patient selection, biomarker analysis and clinical trial monitoring.

Development
We develop products from gene cloning to final drug product focusing on production efficiency and ease of technology transfer and process operations. This “All Stream” approach integrates all aspects of development with the highest level of quality and is designed to improve outcomes by eliminating the traditional “silos” between cell line development, cell culture process development, downstream process development, formulation, analytical chemistry, and product characterization.

GMP Manufacturing
NextCure’s dedicated, state-of-the-art GMP manufacturing facility will support our biologics pipeline and candidates advancing into clinical development. The facility will have an initial production capacity of 1000L with additional room for expansion. The cleanroom space features state-of-the-art construction materials and utilizes single-use production systems. The clinical production space is designed to operate as a multi-product facility to support NextCure’s robust pipeline of first-in-class immunotherapy-based product candidates.  NextCure’s manufacturing capabilities provides: (i) greater control and flexibility in scheduling and prioritization, (ii) assurance of quality, and (iii) capital efficiency to advance our growing pipeline of product candidates.