Immunicum AB (publ) Announces Advancement to a Non-Staggered Inclusion Phase in the Phase Ib/II ILIAD Combination Trial

Press Release

15 June 2020

Immunicum AB (publ) Announces Advancement to a Non-Staggered Inclusion Phase in the Phase Ib/II ILIAD Combination Trial

Immunicum AB (publ; IMMU.ST) announced today 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.

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. 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.