I-Mab Biopharma Receives U.S. FDA IND Clearance for Proprietary CD73 Antibody TJD5
SHANGHAI, China – January18, 2019 –I-Mab Biopharma (“I-Mab”), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announced on January 18th, 2019 that theInvestigational New Drug (IND) application forthe initiation of a Phase 1 clinical study for TJD5 in patients with advanced solid tumour 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.
“This is the second US IND that has advanced through FDA regulatory reviewwithin 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.”
About TJD5
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 tumour microenvironment.
About I-Mab
I-Mab is a dynamic and fast-growing global company exclusively focused on developing first-in-class and best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab's pipeline is driven by the company's development strategy to address unmet needs in China and to bring innovative assets to the world. The company is on track to initiate additional clinical trials in China and the U.S., including multiple Phase II and Phase III studies. I-Mab is on a fast track towards becoming an end-to-end fully integrated biopharma company. The company has been well-recognized by capital markets with the recent $220 million Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com