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2016-12-13

Immunicum AB: Immunicum AB announces FDA clearance of its Investigational New Drug application for INTUVAX in metastatic renal cell carcinoma

GOTHENBURG, Sweden, December 13, 2016 -
Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company
developing sophisticated, safe and efficacious therapeutic cancer treatments,
inducing powerful and long lasting immune responses, today announced that the
United States Food and Drug Administration (FDA) has cleared the Company's
Investigational New Drug application (IND) for INTUVAX. The IND clearance
enables Immunicum to expand its ongoing Phase II study - MERECA
(MEtastatic REnal Cell CArcinoma)
- for the treatment of metastatic renal cell cancer patients, into the United
States.

"It is a very important milestone for Immunicum that the exchange of
information with the FDA has resulted in the IND clearance. This allows us to
move forward with the remaining steps required for the US sites to initiate
patient recruitment," said Dr. Carlos de Sousa, CEO of Immunicum. "Our goal
is to further substantiate the initial encouraging results we have seen in
Europe in the phase I/II study, with clinical data from the US."

Dr. de Sousa added: "As previously announced, the MERECA recruitment process
in Europe is ongoing and patients are actively being enrolled in selected
European centers where Immunicum is conducting the Phase II MERECA study. We
will provide a more comprehensive update of our global clinical development
program for the MERECA study in the first quarter of 2017."

About renal cell cancer / carcinoma

Renal Cell Cancer (RCC) is a cancer that forms in the lining of very small
tubes in the kidney that filter the blood and remove waste products. There
are approximately 273,000 new cases of 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.

For more information, please contact

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

About INTUVAX

INTUVAX is a cancer immune primer, developed for the treatment of solid
tumors. Its active ingredient is activated white blood cells, so called
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 a tumor-specific immune response.

About Immunicum AB (publ)

Immunicum AB (publ) develops cancer immune primers for the treatment of tumor
diseases. A phase II clinical trial for the Company's most advanced product -
INTUVAX®against kidney cancer - has been initiated. The project portfolio
contains additional clinical phase I/II studies in liver cancer and in

gastrointestinal stromal tumors (GIST). Immunicum is listed on Nasdaq First
North Premier.
www.immunicum.com

The company's Certified Adviser is Redeye AB
Ph: + 46 8 545 013 31
www.redeye.se

The information in this press release is disclosed pursuant to the EU Market
Abuse Regulation. The information was released for public disclosure through
the agency of the company's contact person on December 13, 2016 at 13.00 CET

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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

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