Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy

Press Release

16 June 2020

Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy

Immunicum AB (publ; IMMU.ST) announced today that the final data analysis from the clinical study of ilixadencel in patients with Gastrointestinal Stromal Tumors (GIST) has been published in the journal, Cancer Immunology, Immunotherapy. GIST is a rare and difficult-to-treat disease indication and the trial met the primary endpoint of safety showing that ilixadencel in combination with different tyrosine kinase inhibitors (TKIs) had a favorable safety profile with no treatment-related serious adverse events and no signs of autoimmunity. In addition, analysis of the secondary clinical trial endpoints provided initial signals of clinical benefit in two out of six patients that showed tumor shrinkage after adding ilixadencel treatment to TKI treatment despite previous tumor progression on the same TKI.

The final data analysis showed that two out of six patients exhibited partial tumor responses, according to the Choi response criteria (i.e. 33% objective response rate).  The same two patients also exhibited stable disease for 9 months (on third line regorafenib) and 12 months (on second line sunitinib), respectively,  based on the modified RECIST criteria. The partial responses observed indicate that ilixadencel contributed to therapeutic impact by overcoming resistance to TKIs in these two patients with metastatic disease whose disease previously progressed on second- and/or third-line TKI treatment.

“Although the GIST study was a trial with few patients enrolled, they were all at an advanced disease stage, meaning that both the safety data and the signals of clinical efficacy are encouraging and support ilixadencel’s potential as a safe and effective cell-based cancer immune primer. The publication of our clinical results in a peer reviewed journal further validates the quality of the data generated from our clinical study,” said Alex Karlsson-Parra, MD, PhD, CSO and interim CEO of Immunicum.

The full publication titled, "Phase 1 Trial Evaluating Safety and Efficacy of Intratumorally Administered Inflammatory Allogeneic Dendritic Cells (ilixadencel) in Advanced Gastrointestinal Stromal Tumors" can be accessed through the current online version of Cancer Immunology, Immunotherapy and through the following link: https://bit.ly/37xQkVU