The company has completed and announces positive results from the its Phase I/II clinical trial examining the safety and tolerability of the lead candidate, ilixadencel, in combination with tyrosine kinase inhibitors (TKIs) in six patients with Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to-treat disease indication.

The trial showed that ilixadencel had a favorable safety profile, confirming similar data from past studies, in combination with several TKIs. In addition, analysis of the secondary clinical trial endpoints provided initial signals of clinical benefit in two patients that showed partial response to the treatment. The outcome of the GIST study, which Immunicum plans to publish in a peer-reviewed journal, contributes to the body of data supporting ilixadencel’s potential as a safe and effective cell-based, off-the-shelf immune primer in a range of solid tumor cancers.

“Although this study was conducted in a small group of patients, it is important to note that they all were at an advanced disease stage, meaning that both the safety data and the signals of clinical response are encouraging. They support the continued evaluation of ilixadencel’s role in the treatment of solid tumors and contribute to the growing body of data we will collect in our clinical development program this year,” said Peter Suenaert, Chief Medical Officer at Immunicum.

Study Design

The Phase I/II open-label, single arm clinical trial conducted at the Karolinska University Hospital in Stockholm evaluated the safety and efficacy of ilixadencel in unresectable or metastatic GIST patients with tumor progression during ongoing second, third- or fourth-line treatment with TKI therapy. A total of six patients were enrolled. Patients were treated with two intratumoral doses of ilixadencel in combination with their ongoing TKI treatment, which continued for at least three months.

Results

Ilixadencel met the primary endpoint of safety, with no life-threatening treatment-related adverse events and no signs of autoimmunity. The secondary endpoint of efficacy was primarily evaluated based on tumor growth. The most positive outcome was seen in two patients where tumor growth halted and partially regressed for three and six months, respectively. These partial responses 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.

“As a disease with limited therapeutic options, it is a considerable achievement to see partial response in two out of six advanced-stage GIST patients as the disease at that point has developed resistance to standard of care treatment with TKIs,” commented Principal Investigator, Robert Bränström, MD and Associate Professor at Karolinska University Hospital.

Photo of Carlos de Sousa: CEO of Immunicum