Immunicum has announced that a total of 15 patients have now been enrolled in the ongoing Phase Ib/II ILIAD combination trial.
In addition, ilixadencel has maintained a consistent safety profile in the study to-date and the Dose Escalation Committee (DEC) confirmed there were no dose limiting toxicities. The Phase Ib portion of the ILIAD trial will be evaluating the safety and tolerability of Immunicum’s lead cell-based candidate, ilixadencel, in combination with the checkpoint inhibitor (CPI) Keytruda (pembrolizumab) in a total of 21 patients.
Completion of patient enrollment for the Phase Ib portion of the trial in the first half of 2021
In June 2020, the company announced that the non-staggered phase of the trial had started which enabled the recruitment and enrollment of patients to proceed more rapidly as the safety waiting period between patient enrollment was no longer necessary. Now, the DEC evaluated the safety profile for patients treated to date and recommended to continue treatment and open the last cohort to fully enroll the Phase Ib portion of the study.
“The patient enrollment progress we have achieved since the non-staggered phase opened is a positive development in this study and is ahead of the communicated timeline at the last safety update. Nonetheless, we maintain guidance that we expect the completion of patient enrollment for the Phase Ib portion of the trial in the first half of 2021,” says Sven Rohmann, CEO of Immunicum. “The ILIAD trial is an important and exciting part of our core clinical development strategy in which we aim to evaluate ilixadencel in multiple solid tumor indications combined with a modern, standard of care treatment.”
The ILIAD trial
The ILIAD trial includes patients who are candidates for pembrolizumab therapy in its approved label by the FDA, which includes, among others, the tumor types head and neck squamous cell carcinoma, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. In terms of dosing, three patients were planned to receive two intratumoral doses of 3 million cells, six patients two doses of 10 million cells, six patients three doses of 10 million cells and the last six patients will receive one dose of 20 million cells followed by two doses of 10 million cells. The Phase II part of the ILIAD trial will then continue with the selected dose regimen from the Phase Ib. Completion of the Phase Ib trial with longer duration of follow-up of patients for signs of efficacy is expected towards the second half of 2021.