Immunicum has announced that the sixth patient has completed the safety period in the ongoing Phase Ib/II ILIAD combination trial with ilixadencel, the company’s cell-based, off-the-shelf immune primer for the treatment of solid tumors.
The Dose Escalation Committee (DEC) confirmed there were no dose limiting toxicities, therefore the study can move into the non-staggered inclusion phase, states the company.
Ilixadencel in combination with Keytruda
The Phase Ib portion of the ILIAD trial is evaluating the safety and tolerability of Immunicum’s lead candidate, ilixadencel, in combination with the checkpoint inhibitor (CPI) Keytruda (pembrolizumab) in 21 patients. In the staggered part of the Phase Ib portion, the initial 3 patients received the dose level of 3 million cells of ilixadencel followed by 3 patients that received the dose level of 10 million cells of ilixadencel. The non-staggered phase will now allow the remaining 15 patients to proceed more rapidly as there will no longer be a safety waiting period between patient enrollment.
“However, due to the COVID-19 pandemic, the company’s ability to further accelerate enrollment with additional clinical centers may be impacted.”
However, due to the COVID-19 pandemic, the company’s ability to further accelerate enrollment with additional clinical centers may be impacted. The next safety update is therefore expected by the end of 2020, full enrollment of the Phase Ib part of the trial in the first half of 2021 and completion of the Phase Ib with longer duration of follow-up of patients for signs of efficacy towards the second half of 2021.
“To date, ilixadencel has demonstrated a favorable safety profile. As such, the confirmation of no dose limiting toxicities from the Dose Escalation Committee is an encouraging and validating step in the advancement of the ILIAD trial. Now, as we move into the next accelerated phase of testing, we will also be able to evaluate the effect of the different frequencies and dosing levels of ilixadencel. We look forward to announcing the next update on the advancement of enrollment and longer follow-up for potential signs of efficacy,” commented Alex Karlsson-Parra, CEO of Immunicum.
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 have received two intratumoral doses of 3 million cells, six patients will receive 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.
Photo of Alex Karlsson-Parra: Immunicum