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Innovent Biologics, NeoCura Biomedical Technology Partner on Bespoke Immunotherapy Trial in China

NEW YORK – Innovent Biologics and NeoCura Biomedical Technology on Wednesday said they will jointly study Innovent's PD-1 inhibitor sintilimab (TYVYT) plus NeoCura's personalized cancer vaccine NEO_PLIN2101 in China.

San Francisco-based Innovent and Suzhou, China-based NeoCura will collaborate on a clinical trial to evaluate the combined therapies for patients with a variety of solid tumors, with the goal of submitting an investigational new drug application to China's National Medical Products Administration (NMPA).

The trial is designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the treatment combination, which the firms hope will improve patients' responses to sintilimab.

NeoCura developed NEO_PLIN2120 to target cancer neoantigens in a bespoke fashion. The firm sequences patients' samples and uses artificial intelligence-guided epitope prediction to identify neoantigen fragments that they can then target with corresponding mRNA. This process, according to the firm, can activate tumor-specific T cells to attack cancer cells with "stronger specificity and immunogenicity" than conventional treatment approaches.

Sintilimab, meanwhile, which is a joint product of Innovent and Eli Lilly, has demonstrated efficacy in a number of tumor types, both alone and in combination with existing therapies. In China, the drug is approved for certain non-small cell lung cancers, Hodgkin's lymphoma, and liver cancer, and is currently under NMPA review for first-line treatment of esophageal cancer. The US Food and Drug Administration is also reviewing a biologics license application for sintilimab plus chemo for first-line non-squamous NSCLC.

Researchers, however, have been trying to identify biomarkers that predict who will respond to sintilimab, including using gene expression analysis to better characterize the tumor microenvironment.

According to a statement from NeoCura's founder Wang Yi, the company will explore with Innovent the "synergistic role of personalized neoantigen vaccines and monoclonal antibody drugs" and if the combination therapy improves patients' responses to cancer immunotherapy as expected.