PURPOSE OF THIS MODIFICATION IS TO EXERCISE THE I-CORP OPTION

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NomoCan Pharmaceuticals is developing a first-in-class humanized monoclonal antibody, NMC-521, against a novel plasma membrane-bound variant of the protein MDM2 as a targeted treatment for cancer with fewer side effects, initially focusing on pancreatic cancer (PC). PC has one of the lowest 5-year survival rates among all cancer types, remaining below 10% for the past 40 years, indicating a need for effective PC therapies. Studies have shown that NMC-521 binds selectively to several PC cell lines with marked anti-tumor efficacy, having demonstrated therapeutic benefit as a monotherapy or combination therapy. Following these promising results, NomoCan developed a humanized NMC-521 mAb (hu-NMC-521) for further studies. Through this NCI Concept proposal, NomoCan plans to demonstrate the efficacy and selectivity of hu-NMC-521 in vitro, followed by testing in multiple mouse models of PC to confirm the efficacy profile before advancing the lead drug candidate to formulation and toxicology/pharmacology studies in future works. NomoCan aims to confirm the binding of hu-NMC-521 to PM-MDM2 in pancreatic cancer cell lines and primary pancreatic patient tumor samples, as well as the lack of binding to normal pancreatic cells, and normal untransformed cells and screen in vivo immunogenicity of hu-NMC-521 and anti-tumor efficacy in pancreatic cancer mouse models.