Immunicum AB (publ) Announces Upcoming Oral Presentation on MERECA Trial at the ASCO-SITC Clinical Immuno-Oncology Symposium

Press Release

20 December 2019

Immunicum AB (publ) Announces Upcoming Oral Presentation on MERECA Trial at the ASCO-SITC Clinical Immuno-Oncology Symposium

Immunicum AB (publ; IMMU.ST) announced today that the abstract covering data from the Phase II MERECA trial has been accepted for an oral presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium, which will be held February 6-8, 2020 in Orlando, Florida. The MERECA trial investigated the therapeutic benefit of combining Immunicum’s lead product, ilixadencel, and Sutent® (sunitinib) as a first-line treatment in patients with metastatic kidney cancer. Immunicum announced top-line results from the study in the third quarter of 2019 and will present more detailed results at the symposium, including the first half-yearly follow-up of patient survival in the study.

“Only a strictly limited number of abstracts are selected for oral presentation at the world-leading ASCO-SITC Clinical Immuno-Oncology Symposium. The selection of the abstract covering the results from the MERECA trial represents a significant recognition of our work,” commented Alex Karlsson-Parra, Interim CEO of Immunicum.

“The combination treatment of ilixadencel and sunitinib in the MERECA trial remained well-tolerated and rendered complete and durable tumor responses in patients with metastatic kidney cancer. Based on this, the data from the trial have drawn interest from the international scientific and medical community,” added Dr. Magnus Lindskog, Associate Professor at Uppsala University Hospital and MERECA investigator.

In addition, the abstract with the results from the Phase I/II trial of ilixadencel in Gastrointestinal Stromal Tumor (GIST) patients has been accepted for a poster presentation.

Details of the presentations are as follows:

Title: A randomized phase II study with ilixadencel, a cell-based immune primer, plus sunitinib versus sunitinib alone in synchronous metastatic renal cell carcinoma
Session Information: Oral Abstract Session A.
Session Date & Time: February 6, 2020, 1:00 PM-2:15 PM
Presenter: Magnus Lindskog, MD, PhD

Associate Professor Magnus Lindskog is a clinical oncologist at Uppsala University Hospital, Sweden and participated as the principal investigator in the MERECA study.

Title: Phase I trial evaluating safety and efficacy of intratumorally administered allogeneic monocyte-derived cells (ilixadencel) in advanced gastrointestinal stromal tumors.
Session Information: Poster Session A
Session Date & Time: February 6, 2020, 11:30 AM-1:00 PM; 6:00 PM-7:00 PM
Presenter: Alex Karlsson-Parra, MD, PhD

Immunicum will report the presented data, including the first half-yearly follow-up on the survival of the patients in the study, through a press release in connection to the presentations.

MERECA is an exploratory, international, randomized, controlled and open-label Phase II clinical trial in which a total of 88 newly diagnosed, intermediate and poor-prognosis metastatic renal cancer patients were enrolled. Based on a 2-to-1 randomization, patients received either two intratumoral doses of ilixadencel before nephrectomy (surgical removal of the tumor-affected kidney) and subsequent treatment with sunitinib or sunitinib therapy alone post-nephrectomy. The primary objectives of the study are to evaluate median overall survival (OS) and 18-month survival rates. Secondary objectives include evaluation of safety and tolerability, tumor response and immunological profiling including T cell infiltration.

About renal cell cancer / carcinoma
There are approximately 273,000 new cases of Renal Cell Cancer (RCC) diagnosed worldwide each year, representing approximately two percent of all cancers. The therapeutic effect of existing treatments, called targeted therapies, is often of short duration, with limited survival gain. With no alternatives to these therapies, there exists a relatively large unsatisfied medical need for new treatments that are effective, more cost-efficient and have less unwanted side effects.

About GIST
GIST is the most common sarcoma and is highly resistant to conventional radio- and chemotherapy. Although imatinib and other tyrosine kinase inhibitors (TKIs) have revolutionized the medical treatment of unresectable and/or metastatic GIST, TKI resistance still represents a major challenge as therapeutic options for advanced GISTs are limited when the disease progresses.

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, Interim CEO, Immunicum
Telephone: +46 8 732 8400

Michaela Gertz, CFO, Immunicum
Telephone: +46 70 926 17 75

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.



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