On September 10, 2019 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 reported the signing of a collaboration agreement with Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), an innovation-driven biopharmaceutical company to evaluate the combination therapy of I-Mab’s TJD5, a proprietary innovative CD73 antibody with Junshi Biosciences’ Toripalimab (Trade name: Tuoyi), a recombinant humanized anti-PD-1 monoclonal antibody in patients with cancers in China (Press release, I-Mab Biopharma, SEP 10, 2019, View Source [SID1234539422]).
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Dr. Jingwu Zang, Founder and Chairman of I-Mab, commented, "TJD5 is an innovative CD73 antibody with best-in-class potential that has entered into Phase I trial in the US. We are very pleased to collaborate with Junshi to explore the clinical synergies with Toripalimab which is an innovative drug with distinctive treatment advantages. We are looking forward to bringing more clinical benefits to patients across various cancer types."
Dr. Ning Li, CEO of Junshi Biosciences, commented, "As an anti multi-tumor drug, toripalimab has shown good safety and efficacy in clinical trials with mono and combination therapy. We believe, through the cooperation with I-Mab, we could continue to explore the combination potential of toripalimab and innovative drugs to improve the outcomes of immune-oncology therapy, lightening hope for more patients.
About TJD5:
TJD5 is a novel and differentiated blocking antibody against CD73, a surface enzyme on stromal cells and cancer cells responsible for the production of adenosine, which is highly immunosuppressive. It is expected to stimulate the immunosuppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 is in a Phase 1 clinical trial in the US, it is a proprietary innovative CD73 monoclonal antibody from I-Mab’s discovery pipeline with best-in-class potential.
About Toripalimab (JS001, Trade name: Tuoyi)
Toripalimab. a recombinant humanized anti-PD-1 monoclonal antibody for injection is the first domestic-developed anti-PD-1 mAb granted marketing approval in China, supported by National Science and Technology Major Project. In March 2018, its New Drug Application ("NDA") was accepted by the NMPA and put into prioritized evaluation and approval process. On Dec 2018, Toripalimab was conditionally granted marketing approval for use in the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy by the NMPA, which is the first commercialized product of Junshi Biosciences. In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The NDA approval of toripalimab witnessed the pivotal step from pre-revenue biotech start-up to a commercial-stage biopharmaceutical company.
Since Toripalimab started its clinical trials at the beginning of 2016, over 30 trials have been conducted in China, the US and other countries, covering 14 kinds of tumors, i.e. NPC, UC, lung cancer, EC, HCC, TNBC, etc. Cooperations with domestic and overseas innovation pharma companies on combination therapy are also under exploration.