Immunicum has announced the completion of patient recruitment for the Phase Ib portion of the ongoing ILIAD (ILIxadencel in combination with checkpoint inhibitors in ADvanced cancer patients) trial.
The primary objective of the Phase Ib study is to evaluate the safety and tolerability as well as define the dose regimen for Immunicum’s lead cell-based candidate, ilixadencel, in combination with the checkpoint inhibitor (CPI), Keytruda (pembrolizumab), in a total of 21 patients. The follow-up period for the Phase Ib portion of the trial will include imaging of up to 6 months for evaluation of safety, dosing and signs of efficacy. Topline results of the Phase Ib trial are expected during the third quarter of 2021.
“The Phase Ib/II ILIAD trial remains a critical piece of our clinical development strategy, and we look forward to continuing to provide updates on our newly expanded clinical pipeline.”
“Successfully finishing patient recruitment for the Phase Ib portion of the ILIAD trial stands as an important achievement, particularly during a year in which clinical trials, patient recruitment and standard operations have been impacted by the Covid-19 pandemic,” commented Sven Rohmann, CEO of Immunicum. “The completion of this milestone brings us one step closer to the topline data readout expected during Q3 next year, which will give us further insight into the potential of ilixadencel in a range of indications and in combination with checkpoint inhibitors. The Phase Ib/II ILIAD trial remains a critical piece of our clinical development strategy, and we look forward to continuing to provide updates on our newly expanded clinical pipeline.”
The Phase Ib/II ILIAD combination trial
The Phase Ib/II ILIAD combination 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.
Throughout the duration of the trial, the Dose Escalation Committee (DEC) has assessed ilixadencel’s safety profile. The last update from the DEC in October confirmed there had been no dose-limiting toxicities. The Phase II portion of the ILIAD trial can subsequently continue with the selected dose regimen from the Phase Ib.
Photo of Sven Rohmann: Immunicum