TRACON begins phase 1 TJD5 clinical trial in advanced solid tumors

TJD5 clinical trial : US biopharma company TRACON Pharmaceuticals has dosed the first patient in a US phase 1 clinical trial of I-Mab Biopharma’s CD73 antibody TJD5 (TJ004309) in patients with advanced solid tumors.

TJD5 will be dosed in the early-stage trial as a single agent and also in combination with Roche’s PD-L1 antibody TECENTRIQ (atezolizumab).

In April 2019, I-Mab signed a research collaboration with Roche under which the latter agreed to supply TECENTRIQ to the former for use in a clinical trial in combination with TJD5.

Commenting on TJD5 clinical trial, Joan Shen – Head of R&D of I-Mab, said: “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 US.

“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.

“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.”

TJD5 clinical trial

TRACON begins phase 1 TJD5 clinical trial in advanced solid tumors. Image courtesy of renjith krishnan at FreeDigitalPhotos.net

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

TJD5 is a differentiated humanized antibody against CD73 from I-Mab’s discovery pipeline, which is being co-developed with TRACON as per a collaboration agreement signed in November 2018. The two pharma companies have a second partnership to develop up to five bispecific antibodies from the immuno-oncology portfolio of I-Mab.

Charles Theuer – President and CEO of TRACON, commenting on TJD5 clinical trial, said: “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.

“We will continue to work with I-Mab to optimize the clinical development of TJD5, an antibody with global best-in-class potential.”

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