• Ph II study will include up to 150 patients
• The study will include testing in head and neck cancer, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma
• Overall ilixadencel is being studied in six cancer types
• Immunicum has two additional immuno-oncology drugs under development

Immunicum AB (publ; IMMU.ST) announced on 7/23/18 that the U.S. Food and Drug Administration (FDA) has approved the clinical trial protocol for its planned Phase Ib/II trial to evaluate the safety and efficacy of intratumorally-administered ilixadencel in combination with checkpoint inhibitors (CPI). The regulatory approval allows the company to start the process of patient enrollment. As previously communicated, Immunicum expects the trial to enroll the first patient in the second half of 2018.

The trial, abbreviated ILIAD, is an Immunicum-sponsored, randomized, open-label, multicenter Phase Ib/II study to evaluate the safety and efficacy of intratumorally-administered ilixadencel in combination with CPIs. It will test the combination in three indications: head and neck cancer, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. The trial will be divided into two parts: Phase Ib and Phase II. The aim of the Phase Ib part of the study is to assess safety and define the optimal dose and schedule of ilixadencel administration in combination with standard doses of pembrolizumab (Keytruda®) in patients with any of these three types of cancers.

Importantly, the Phase Ib part of the study will now include 21 patients as compared to the 9 in the original draft protocol that was completed in the third quarter 2017. This development in trial design was based on input from clinical experts and EU regulatory authorities as well as guidance from the FDA. The expansion will contribute more data on dose levels and treatment schedules for use in the Phase II and has the potential to capture initial indications of efficacy. There will be an impact on the duration of the Phase Ib, which will also depend on the start and pace of patient enrollment.

The Phase II part of the trial will include up to 150 subjects randomly assigned in a 2:1 fashion to ilixadencel combined with a CPI versus a CPI alone. In this phase, the patients will be grouped by indication into three studies advancing in parallel. The aim of the Phase II study is to demonstrate a favorable impact of ilixadencel used in combination with CPIs.  Each indication group will include enough patients to observe a statistically significant difference in clinical activity between the different treatment groups.

Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells generates an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T-cells.  

Ilixadencel is currently being studied in six types of cancer. Immunicum has two additional immuno-oncology candidates under development.