Immunicum AB (publ) Announces Last Patient Last Visit in the Ongoing Phase I/II Hepatocellular Carci

Immunicum AB (publ) Announces Last Patient Last Visit in the Ongoing Phase I/II Hepatocellular Carcinoma Study

ID: 556526

(Thomson Reuters ONE) -




Press Release

15 August 2017

Immunicum AB (publ) Announces Last Patient Last Visit in the Ongoing Phase I/II
Hepatocellular Carcinoma Study

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 last patient last visit in the ongoing Phase I/II study of
ilixadencel in hepatocellular carcinoma (HCC). The open label study enrolled
eighteen patients and was conducted at the Sahlgrenska University Hospital at
Gothenburg University. Topline results from the study following data analysis
are anticipated before the end of the year. Ilixadencel, formerly known as
INTUVAX, is a cancer immune primer developed for the treatment of solid tumors
and is currently also being investigated in an ongoing Phase II trial in renal
cell carcinoma (MERECA) as well as a Phase I/II study in gastrointestinal
stromal tumors.

"Today's announcement continues the significant progress we have made within our
clinical programs this year to demonstrate ilixadencel's therapeutic potential
as an off-the-shelf immune primer in solid tumors. HCC in particular is a very
severe type of cancer with limited treatment options and a strong demand for
novel, innovative therapies such as ilixadencel," said Peter Suenaert, MD, PhD,
Immunicum's Chief Medical Officer. "Especially in this rapidly advancing type of
cancer, the ability to extend survival by even a few months is a positive
benefit. The interim results we presented at the SITC Annual meeting last
November were promising and we look forward to the complete results, which we
hope to communicate before end of year."

The open-label phase I/II trial was initiated by Immunicum in 2013 to




investigate safety and efficacy of ilixadencel, Immunicum's lead cancer immune
primer, as second and first line therapy in HCC. Conducted at the Sahlgrenska
University Hospital at Gothenburg University, the primary objective of the study
is to investigate safety of the cell therapy product. Secondary objectives
include immunological response and initial signs of efficacy on overall
survival. In total, eighteen patients were enrolled in the study, seventeen with
advanced HCC and one with bile-duct cancer (following protocol amendment). All
patients were treated with at least one intratumoral dose of ilixadencel either
as a monotherapy or in combination with first line treatment sorafenib. Interim
results presented at the SITC Annual meeting in November 2016 demonstrated a
good safety and tolerability profile.

More information on the study can be found on the clinicaltrial.gov page through
the following link:
https://www.clinicaltrials.gov/ct2/show/NCT01974661?term=Immunicum&rank=3



About hepatocellular carcinoma
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors
worldwide and the most common cause of death in people with liver cirrhosis.
Progression is very rapid and prognosis is poor due to the inability to
completely remove the tumor through surgery in most cases. Malignant
transformation of liver cells may occur as a consequence of various origins,
such as chronic viral hepatitis, alcohol, and metabolic disorders.

About ilixadencel
Ilixadencel 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 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(at)immunicum.com
Investor Relations Sweden

Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg(at)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(at)macbiocom.com or smay(at)macbiocom.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 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






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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Bereitgestellt von Benutzer: hugin
Datum: 15.08.2017 - 08:00 Uhr
Sprache: Deutsch
News-ID 556526
Anzahl Zeichen: 6152

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