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news.Dynavax Technologies has initiated a phase I dose escalation trial of its TLR9 agonist in combination with a chemotherapy for colorectal cancer.
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The trial is designed to identify the optimum dose and to yield safety and tolerability data for escalating doses of a Dynavax TLR9 agonist administered with irinotecan and cetuximab. The company anticipates that the trial will be completed in the first half of 2007 and plans to use the data to design a larger phase II trial. Initiation of a phase II study in this indication is expected in 2007.
“In preclinical studies, our TLR9 agonist has shown anti-tumor activity when administered alone and in combination with monoclonal antibodies or chemotherapeutic agents,” noted Dr Eduardo Martins, vice president of clinical development.
Dynavax indicated that the trial is the first of several slated to enter the clinic with funding from Symphony Capital. In April, 2006, Symphony committed $50 million to Dynavax to advance the cancer program and human trials in chronic hepatitis B and chronic hepatitis C. An ongoing phase II trial funded by the National Institutes of Health is evaluating the use of a TLR9 agonist with Rituxan in non-Hodgkins lymphoma.