TRACON Pharmaceuticals Inc (NASDAQ:TCON) has presented updated data from its Phase 1 study of TJ004309 (uliledlimab) and Tecentriq (atezolizumab) at the American Society of Clinical Oncology (ASCO) virtual annual meeting.
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” -- the company said data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab.
In a statement, TRACON said key results included:
- Uliledlimab was safe and well-tolerated up to 20 milligrams of drug per kilogram of body weight (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 Dr Francisco Robert, 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.”
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