Immunicum has received protocol approval from the US Food and Drug Administration (FDA) to begin the ILIAD Phase Ib/II trial to investigate the safety and efficacy of intratumorally administered ilixadencel in combination with checkpoint inhibitors (CPIs) for three types of cancer indications.

The indications include head and neck cancer, non-small cell lung cancer, and gastric and gastroesophageal junction adenocarcinoma.

The newly granted approval has allowed Immunicum to start the process of patient enrolment for the trial, which is expected to include the first patient in the second half of this year.

The trial will have two parts, Phase Ib and Phase II.

The Phase Ib part of the trial will aim to evaluate safety and define the optimal dose and schedule of ilixadencel in combination with standard doses of pembrolizumab (Keytruda) in patients with any of the three types of cancers.

In the Phase Ib part of the trial, 21 patients are expected to be enrolled as against the nine planned in the original draft protocol of the trial that was completed in the third quarter of last year.

“The newly granted approval has allowed Immunicum to start the process of patient enrolment for the trial.”

This amendment was made after receiving input from clinical experts and European Union (EU) regulatory authorities, as well as guidance from the FDA.

According to Immunicum, the expansion phase will provide more data on dose levels and treatment schedules for use in the Phase II and has the potential to capture initial indications of efficacy.

The duration of the Phase Ib part will be based on the start and pace of patient enrolment.

Up to 150 subjects are expected to be included in the Phase Ib to randomly assign in a 2:1 ratio to receive ilixadencel combined with CPIs versus CPIs alone.

Following enrolment, the patients will be grouped by indication into three trials advancing in parallel.

The Phase II part of the trial seeks to demonstrate a favourable impact of ilixadencel used in combination with CPIs.

As part of the trial, each indication group will enrol enough patients to observe a statistically significant difference in clinical activity between the different treatment groups.