I-Mab Biopharma announced the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study for TJD5 in patients with advanced solid tumor has cleared the required 30 day review by the U.S. Food and Drug Administration (FDA). The IND application was filed by I-Mab's strategic partner TRACON Pharmaceuticals in December 2018.
TJD5, also known as TJ004309, is a CD73 antibody from I-Mab's proprietary discovery pipeline and is now co-developed with TRACON via an agreement signed on November 28, 2018, as part of a broad strategic partnership to develop multiple immuno-oncology programs with first-in-class and best-in-class potential from I-Mab's immuno-oncology portfolio.
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"This is the second US IND that has advanced through FDA regulatory review within one month, which further advances our objective of developing innovative therapy for patients worldwide and recognizes the global value of our proprietary assets," said Joan Shen, M.D., Ph.D., Head of R&D at I-Mab. "As we combine the resources and expertise with our partner, the collaboration will enable us to efficiently and effectively develop TJD5 in the United States by leveraging the world-class clinical expertise, which in turn helps I-Mab to accelerate the clinical programs for TJD5 in China as well."
TJD5 is a novel, humanized antibody against CD73 that can completely suppress the CD73 enzymatic activity with a differentiated binding mode. CD73 is highly expressed on various cancer cells that converts extracellular adenosine monophosphate (AMP) to adenosine, leading to the formation of immunosuppressive tumor microenvironment.