Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in Combination with Cancer Therapies and Immunotherapies at the 2020 Virtual ESMO Congress

Press Release

17 September 2020

Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in Combination with Cancer Therapies and Immunotherapies at the 2020 Virtual ESMO Congress

Immunicum AB (publ: IMMU.ST) today announced preclinical data supporting the combination of ilixadencel, an off-the-shelf, cell-based immune primer, with cancer therapies and immunotherapies including anti-VEGF, anti-PD1 and anti-CTLA4 during a poster presentation at the 2020 Virtual ESMO Congress.

Earlier communicated results from preclinical studies in mice demonstrated that animals treated with the combination of ilixadencel and anti-CTLA4 showed a stronger anti-tumor response as compared to animals treated with anti-PD1 and anti-CTLA4, a potent and marketed combination of checkpoint inhibitors. Following the completion of additional experiments, Immunicum observed that ilixadencel, when combined with, anti-VEGF, anti-CTLA4 or anti-CTLA4 and anti-PD1, enabled Complete Responses in a colon carcinoma tumor model (CT26) in mice.

“Our preclinical studies are focused on evaluating ilixadencel in combination with different cancer therapies to identify the most synergistic combinations to explore in clinical trials and gain further insight on ilixadencel’s mechanism of action. The preclinical results on tumor response and survival with ilixadencel in combination with anti-VEGF antibodies are further in line with the outcome of the MERECA trial in which ilixadencel was tested in kidney cancer patients in combination with the VEGF inhibitor, sunitinib, indicating that the anti-tumor effect seen in the used tumor model has clinical relevance. From these additional preclinical experiments, we also see strong mechanistic and efficacy rationale of investigating novel combinations. Overall, as we strengthen our data package, we look forward to providing updates on the next steps for our clinical development program,” commented Alex Karlsson-Parra, Chief Scientific Officer of Immunicum.  

In the experiments, groups of 5 to 10 mice with established tumors (approximately 100 mm³) were administered either monotherapy, ilixadencel in combination with anti-VEGF, anti-PD1 or anti-CTLA4 or the triple combination of ilixadencel, anti-PD1 and anti-CTLA4. One control group was treated with anti-PD1 combined with anti-CTLA4. Results from two experiments demonstrated that 50-70% of the treated mice in the ilixadencel/anti-CTLA4 groups showed a Complete Response and were found to be protected from tumor regrowth upon subsequent tumor rechallenge. An additional experiment further demonstrated that the addition of ilixadencel to anti-PD1 and anti-CTLA4 resulted in a Complete Response in 60% of the treated mice, as compared to 10% for the anti-PD1/anti-CTLA4 control group. In the ilixadencel/anti-VEGF group, tumor progression was delayed and resulted in a Complete Response in 10% of the treated mice, as compared to 0% for the anti-VEGF control group. Immune cell depletion experiments were conducted in the ilixadencel combination with anti-CTLA4, demonstrating that the effects are primarily driven by CD8+ T cells, with substantial involvement of both CD4+ T cells and NK cells, thus in line with ilixadencel’s anticipated mechanism of action.

The poster presentation is available on Immunicum’s corporate website.

About ilixadencel
Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Injection of these cells in the patient’s tumor generates an inflammatory response which in turns leads to tumor-specific activation of the patient’s cytotoxic T cells. To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab). Ilixadencel has consistently maintained a positive safety and tolerability profile and demonstrated initial signs of efficacy as seen in the randomized Phase II MERECA trial. Ilixadencel is currently moving towards late-stage clinical development.

For more information, please contact:

Alex Karlsson-Parra, CSO, Immunicum
Telephone: +46 8 732 8400
E-mail: info@immunicum.com

Sijme Zeilemaker, COO, Immunicum
Telephone: +46 8 732 8400
E-mail: info@immunicum.com

INVESTOR RELATIONS

Jonas Rodny
Paues Åberg Communications
Telephone: +46 76 190 90 51
E-mail: ir@immunicum.com

Media Relations

Gretchen Schweitzer and Joanne Tudorica
Trophic Communications
Telephone: +49 172 861 8540
E-mail: ir@immunicum.com

About Immunicum AB (publ) Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient’s own immune system to fight cancer. The company’s lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Immunicum has evaluated ilixadencel in several clinical trials including the recently completed exploratory Phase II MERECA study in kidney cancer and the Company is moving towards late-stage clinical development. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com

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• 20200917_ESMO Preclinical Data Announcement_ENG_Final