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Press Release

Immunicum AB (publ) Announces Completion of Patient Recruitment for Phase II MERECA Trial

Immunicum AB
Posted on: 08 Jan 18
Press Release

8 January 2018

Immunicum AB (publ) Announces Completion of Patient Recruitment for Phase II MERECA Trial

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 completion of patient recruitment for the ongoing, global Phase II MERECA (MEtastatic REnal Cell CArcinoma) clinical trial. The study's primary objective is to provide proof of concept for ilixadencel through the achievement of multiple endpoints indicative of meaningful clinical impact and safety assessed over an 18-month period.

"We are very pleased to have achieved this important milestone in the MERECA study, the first of our clinical trials that will provide comparative data about ilixadencel's therapeutic impact when combined with standard of care. Enrollment completion means we will be able to communicate the key final results in the third quarter of 2019 as planned," said Carlos de Sousa, CEO of Immunicum. "With the recently secured funding of 200 million SEK, we are on track to complete MERECA and reach the first decision point in the multi-indication checkpoint inhibitor combination study. As defined by our clinical development plan, these trials will provide further validation of ilixadencel as a safe and unique immune primer with broad potential in combination cancer therapy of solid tumors."

The final number of patients randomized in the trial is 88, meeting the requirements of the study design and validity of the protocol, which had targeted to enroll up to 90 patients. The MERECA study is an international, randomized, controlled and open Phase II clinical trial. The aim is to examine 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 treatment with the standard of care-drug, sunitinib. In the control arm, patients are treated with sunitinib only, post surgical removal of the tumor-affected kidney. The study is designed to 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, a cell therapy product (formerly known as INTUVAX®), is an off-the-shelf 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 generates an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T-cells.

The information is such information that Immunicum is obliged to make public pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the contact persons detailed below on 8 January 2018 at 8.00 am CET.

For more information, please contact:

Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52

Investor Relations Sweden

Helena Stångberg
Hallvarsson & Halvarsson
Telephone: +46 709 71 12 53

Investor and Media Relations EU/US

Gretchen Schweitzer
Trophic Communications
Telephone: +49 172 861 8540

The Company's Certified Adviser is Redeye AB
Telephone: +46 (0)8 545 013 30

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.

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Immunicum AB via GlobeNewswire

Last updated on: 09/01/2018

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