On June 4, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, reported that updated data from the Company’s Phase 1 study of TJ004309 and Tecentriq (atezolizumab) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual annual meeting (Press release, Tracon Pharmaceuticals, JUN 4, 2021, View Source [SID1234583534]).

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In poster presentation 2511 entitled, "The safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer," data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab.

Key results included:

Uliledlimab was safe and well-tolerated up to 20 mg/kg every three weeks (Q3W) and 15 mg/kg once weekly (QW) as a monotherapy and in combination therapy with atezolizumab 1200 mg Q3W. No dose limiting toxicity was observed and the maximum tolerated dose was not reached.
Full saturation of circulating and cell-bound CD73 was achieved at doses ≥ 10 mg/kg.
Linear PK profile was observed at the doses ≥10 mg/kg following a single dose and the PK profile of uliledlimab supports Q3W dosing.
There was evidence of clinical activity (one complete response, two partial responses and three cases of stable disease) in both PD-(L)1 treatment naïve and refractory cancer patients, following treatment with uliledlimab and atezolizumab.
Higher tumor CD73 and PD-L1 co-expression were found in responders compared to non-responders.
"Uliledlimab was safe and refractory solid tumor patients benefitted following treatment with uliledlimab and atezolizumab," said Francisco Robert M.D., lead author and Professor of Medicine at the University of Alabama, Birmingham. "Further evaluation of uliledlimab in combination with checkpoint inhibitors in lung and ovarian cancers is warranted."

The poster is available on TRACON’s website at www.traconpharma.com.

About TJ004309

TJ004309 is a novel, humanized antibody discovered by I-Mab, against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TRACON is developing TJ004309 in collaboration with I-Mab Biopharma through one of our two strategic agreements with them, whereby we are responsible for the regulatory and clinical development of TJ004309 in the U.S. and Europe for this study. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.