Immunicum AB (publ) Announces Enrollment of First United States Patient in the Ongoing Phase 2 MERECA Trial for Ilixadencel

GOTHENBURG, Sweden I August 10, 2017 I Immunicum AB (publ; First North Premier: IMMU.ST), a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced the enrollment  of the first patient in the United States (US) as part of the Company's ongoing global Phase 2 MERECA (MEtastatic REnal Cell CArcinoma) trial. The trial is investigating the safety and efficacy of Immunicum's lead drug candidate ilixadencel, formerly known as INTUVAX, a cancer immune primer that is designed to specifically reactivate the patient's immune system to recognize and destroy tumor cells.

"With the first metastatic kidney cancer patient enrolled in the United States, we have achieved another important milestone for Immunicum. The continued expansion of our clinical program underscores the dedication of our team to realize ilixadencel's potential and to execute a global clinical trial including meeting all regulatory and manufacturing requirements in the US which are significant for a cell-based therapy," said Dr. Peter Suenaert, CMO of Immunicum.

"This is a significant step for Immunicum and I am very pleased that the first patient has been  enrolled in the US and that we are continuing to advance ilixadencel, our innovative immune priming cell therapy approach, through the clinic," said Carlos de Sousa, CEO of Immunicum.

The MERECA study is currently ongoing in eight European countries and is now rolled out in the US.  It examines the safety, tumor-specific immune activation and potential for clinical efficacy of two intratumoral doses of ilixadencel before surgical removal of the tumor-affected kidney and subsequent systemic treatment with sunitinib. In addition to analyzing the immune system activating effects of ilixadencel treatment, the study will also provide data on the clinical benefit through survival rate at 18 months and median overall survival for all patients.

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 directed therapies, is often of short duration, with limited survival rate 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 ilixadencel
Ilixadencel cell therapy product (formerly known as INTUVAX) is a cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T-lymphocytes.

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. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq First North Premier. www.immunicum.com

SOURCE: Immunicum

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