The first patient has been treated in the Phase Ib/II ILIAD clinical trial evaluating the safety and efficacy of Immunicum’s lead product in development, ilixadencel, in combination with checkpoint inhibitors (CPIs) in three cancer indications: head and neck cancer, non-small cell lung cancer and gastric cancer.
The ILIAD trial is an open-label multicenter study fully sponsored by Immunicum. The trial is divided into two parts. The first part, Phase Ib, will assess safety and define the optimal dose and schedule of ilixadencel administration in combination with standard dose of the CPIpembrolizumab (Keytruda), in 21 patients.
The Phase II part
The Phase II part, which will include up to 150 patients, will consist of three randomized, controlled studies conducted at centers in the United States and across Europe. These studies will further determine the safety and efficacy of ilixadencel when administered together with CPI therapy. This study will give the company the opportunity to further evaluate ilixadencel’s potential as a backbone component in combination therapies to treat solid tumors.
Immunicum will report after each dosing group is completed and expects to have the first announcement related to the trial in the second half of 2019.
Photo of Carlos de Sousa: Immunicum