I-Mab, TRACON initiate Phase 1 Trial of the CD73 antibody TJD5

I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, and TRACON Pharmaceuticals (TRACON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, have jointly announced 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).

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 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.

The multicenter, open-label, dose escalation Phase 1 study will evaluate the safety and tolerability of TJD5, and determine recommended doses for further clinical studies of its efficacy and safety as a single agent and in combination with standard dose of TECENTRIQ® in patients with advanced or metastatic cancer who are refractory to or intolerant of all available therapies.

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.