IMMU Immunomedics Inc

Press Release

12 June 2017

Immunicum AB (publ) Announces Approval of the International Nonproprietary Name (INN) ilixadencel for INTUVAX®

--New Designation is One of the First Cell-based Therapy Names Established by the World Health Organization--

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 that the Company received approval of the International Nonproprietary Name (INN), ilixadencel, for the Company's lead program INTUVAX^®, a cancer immune primer designed to specifically reactivate the patient's immune system to recognize and destroy tumor cells. The INN system has been established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique and globally recognized manner. Ilixadencel was the chosen nonproprietary, or "generic" name selected by the World Health Organization (WHO) through their close collaboration with the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.

"The approval of INTUVAX' own INN, one of the first names ever established for cell-based therapies by the WHO, is in part a recognition of the unique nature of our product. This allows us to be consistent working with clinicians worldwide and continuing to advance our global development program for ilixadencel," said Carlos de Sousa, CEO of Immunicum. "We are pleased to have had our application for the INN accepted and confirmed by the WHO. From this point forward, we will use the nomenclature ilixadencel in all of our future communications regarding this cell therapy."

Ilixadencel is an "off-the-shelf" allogeneic cell-based immunotherapy that is currently being evaluated in an ongoing global Phase 2 trial known as MERECA (MEtastatic REnal Cell CArcinoma) in kidney cancer patients. The trial is investigating the safety and efficacy of ilixadencel and is currently underway in eight countries in the European Union and has been cleared for initiation in the United States by the Food and Drug Administration. It is also in Phase 1 studies to evaluate it as a potential treatment for liver cancer and gastrointestinal stromal tumors.

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.

For more information, please contact:

Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com

Investor Relations Sweden

Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg@halvarsson.se

Investor and Media Relations EU/US

MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Telephone: +49 89 2424 3494 or +49 175 5711562
E-mail: gschweitzer@macbiocom.com or smaymacbiocom.com

The Company's Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se

About Immunicum AB (publ) Immunicum is establishing a distinct immuno-oncology approach through the development of an allogeneic off-the-shelf cell-based therapy. 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, 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

 

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