On August 1, 2019 I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focusing on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, and TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, jointly reported that TRACON has dosed the first patient in a U.S. Phase 1 first-in-human clinical trial of I-Mab’s proprietary CD73 antibody TJD5, also known as TJ004309, in patients with advanced solid tumors (NCT identifier number: NCT03835949) (Press release, Tracon Pharmaceuticals, AUG 1, 2019, View Source [SID1234538036]). TJD5 will be dosed in the Phase 1 trial both as a single agent and in combination with TECENTRIQ (atezolizumab), a PD-L1 antibody marketed by Roche. I-Mab entered into a research collaboration with Roche in April 2019 where Roche agreed to supply TECENTRIQ to I-Mab for use in clinical study in combination with TJD5.
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The multicenter, open-label, dose escalation Phase 1 study will evaluate safety and tolerability of TJD5, and determine a recommended dose for further clinical studies of its efficacy and safety as a single agent and in combination with standard dose TECENTRIQ in patients with advanced or metastatic cancer who are refractory to or intolerant of all available therapy.
TJD5, a novel, differentiated humanized antibody against CD73, is from I-Mab’s proprietary discovery pipeline being co-developed through a corporate collaboration between TRACON and I-Mab signed in November 2018. The two companies have a second broader strategic partnership to develop up to five bispecific antibodies from I-Mab’s immuno-oncology portfolio.
"TJD5 builds on earlier successes of I-Mab’s proprietary innovative pipeline and is the third internally discovered drug candidate to enter clinical studies in the U.S. This clinical milestone is the result of our well-executed ‘Fast-to-PoC (proof of concept) Global Approach’ to advancing our proprietary innovative drug candidates towards clinical validation in the United States, and a testament to the productive strategic partnership with TRACON," said Joan Shen, M.D., Ph.D., Head of R&D of I-Mab. "Treatment resistance to PD-1/PD-L1 is one of the major challenges across cancer types. We hope the combination of TJD5 and TECENTRIQ will provide a novel treatment option to address the unmet medical needs."
"Submitting the IND and dosing the initial cancer patient with TJD5 following the signing of our first partnership agreement with I-Mab is an important milestone, as we have both expanded our pipeline in immuno-oncology and further demonstrated TRACON’s product development capabilities designed to reduce the cost and time of clinical development for our partners," commented Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We will continue to work with I-Mab to optimize the clinical development of TJD5, an antibody with global best-in-class potential."
About TJD5 (TJ004309)
TJD5 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJD5 is in a Phase 1 clinical trial in the US to assess the tolerability and preliminary efficacy as a single agent and in combination with TECENTRIQ, a PD-L1 antibody marketed by Roche, in patients with advanced solid tumors. The antibody is also expected to be studied in clinical trials in China sponsored by I-Mab.