Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology

Press Release

21 January 2019

Immunicum AB (publ) Announces Publication of Phase  I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology

Immunicum AB (publ; IMMU.ST) announced today that the final data analysis from the exploratory clinical study of ilixadencel in patients with advanced hepatocellular carcinoma (HCC) has been published in the journal, Frontiers in Oncology. The data confirms previously communicated positive safety and tolerability of ilixadencel when administered both alone and in combination with current first-line standard of care, sorafenib. In addition, the data demonstrate an increased frequency of tumor-specific CD8+ T cells in circulating blood for a majority of evaluable patients, indicating a systemic immune response. The complete results provide further insight on ilixadencel's mode of action, signs of clinical activity and important information that will guide the next stage of clinical development.

As communicated in September 2017, the Phase I/II clinical study in 17 patients with unresectable and/or metastatic HCC and 1 patient with advanced cholangiocarcinoma (bile duct cancer) investigated the safety and tolerability of ilixadencel as a primary endpoint in this setting. The treatment regimen included three separate intratumoral injections of ilixadencel at approximately Day 1, 14 and 42 and patients were followed for at least 6 months after the last injection. Ilixadencel was administered either as a second-line therapy for patients not responding to previous treatment with sorafenib or as a first-line therapy alone or in combination with sorafenib.

The results of the study confirmed the safety of ilixadencel as a single agent or in combination with sorafenib and showed that ilixadencel produces immunological responses in advanced HCC as demonstrated by the induced expansion of tumor-specific CD8+ T cells in peripheral blood in 11 out of 15 evaluable patients. Regarding clinical impact, the data showed positive signals, in particular in the ilixadencel monotherapy group (11 patients), in which one patient's tumor responded to the treatment with a tumor regression (partial response), and 4 patients' tumors stopped progressing (stable disease) during the study. In the group of 6 patients receiving ilixadencel in combination with sorafenib in the first-line setting, the data showed no tumor responses and one patient with stable disease. This outcome in the sorafenib combination group is in line with recent preclinical data included in the publication, indicating that sorafenib's mode of action may not be an attractive combination with ilixadencel, in contrast to sunitinib and checkpoint inhibitors.