Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Car...
January 21 2019 - 2:30AM
Press Release
21 January 2019
Immunicum AB (publ) Announces Publication of Phase I/II
Clinical Trial Results of Ilixadencel in Advanced Hepatocellular
Carcinoma in
Frontiers in Oncology
Immunicum AB
(publ; IMMU.ST) announced today that the final data analysis from
the exploratory clinical study of ilixadencel in patients with
advanced hepatocellular carcinoma (HCC) has been published in the
journal, Frontiers in
Oncology. The data confirms previously
communicated positive safety and tolerability of ilixadencel when
administered both alone and in combination with current first-line
standard of care, sorafenib. In addition, the data demonstrate an
increased frequency of tumor-specific CD8+ T cells in circulating
blood for a majority of evaluable patients, indicating a systemic
immune response. The complete results provide further insight on
ilixadencel's mode of action, signs of clinical activity and
important information that will guide the next stage of clinical
development.
As communicated in September 2017,
the Phase I/II clinical study in 17 patients with unresectable
and/or metastatic HCC and 1 patient with advanced
cholangiocarcinoma (bile duct cancer) investigated the safety and
tolerability of ilixadencel as a primary endpoint in this setting.
The treatment regimen included three separate intratumoral
injections of ilixadencel at approximately Day 1, 14 and 42 and
patients were followed for at least 6 months after the last
injection. Ilixadencel was administered either as a second-line
therapy for patients not responding to previous treatment with
sorafenib or as a first-line therapy alone or in combination with
sorafenib.
The results of the study confirmed
the safety of ilixadencel as a single agent or in combination with
sorafenib and showed that ilixadencel produces immunological
responses in advanced HCC as demonstrated by the induced expansion
of tumor-specific CD8+ T cells in peripheral blood in 11 out of 15
evaluable patients. Regarding clinical impact, the data showed
positive signals, in particular in the ilixadencel monotherapy
group (11 patients), in which one patient's tumor responded to the
treatment with a tumor regression (partial response), and 4
patients' tumors stopped progressing (stable disease) during the
study. In the group of 6 patients receiving ilixadencel in
combination with sorafenib in the first-line setting, the data
showed no tumor responses and one patient with stable disease. This
outcome in the sorafenib combination group is in line with recent
preclinical data included in the publication, indicating that
sorafenib's mode of action may not be an attractive combination
with ilixadencel, in contrast to sunitinib and checkpoint
inhibitors.
"With the broad potential of
ilixadencel, it is important for us to gain insight on specific
indications and treatment regimens. The clinical and biological
information gathered through this trial has been invaluable to our
understanding of safety, mechanism of action of ilixadencel and
potential clinical activity in HCC, and we are pleased to have the
results of the trial peer-reviewed and published in a well-reputed
international scientific journal," said Peter Suenaert, MD, PhD,
Chief Medical Officer at Immunicum. "The safety profile of
ilixadencel and the immune priming results corroborate our
previously reported data and provide a firm foundation to continue
exploring the potential of ilixadencel as part of combination
treatment in liver cancer."
"We are most encouraged by the
demonstration of a tumor-specific immune response in the majority
of patients in the trial, all of whom were suffering from an
advanced and severe form of a cancer that has very few treatment
options," said Alex Karlsson-Parra, MD, PhD, Chief Scientific
Officer of Immunicum. "Our objective is to continue investigating
ilixadencel with different combination treatments to validate our
approach of positioning ilixadencel as an backbone therapy for
solid tumors."
The full publication titled "Phase
I Trial with the Cell-Based Immune Primer Ilixadencel, Alone and
Combined with Sorafenib, in Advanced Hepatocellular Carcinoma" can
be accessed through the current online version of the Frontiers in Oncology journal, specifically in the
section "Cancer Immunity and Immunotherapy" and through the
following link
https://www.frontiersin.org/articles/10.3389/fonc.2019.00019/full.
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, a cell therapy product,
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.
For more information, please contact:
Carlos de Sousa, CEO,
Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com
Michaela Gertz, CFO,
Immunicum
Telephone: +46 70 926 17 75
E-mail: ir@immunicum.com
Media Relations
Gretchen Schweitzer or Joanne
Tudorica
Trophic Communications
Telephone: +49 89 2388 7735 or +49 176 2103 7191
E-mail: ir@immunicum.com
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 Stockholm. www.immunicum.com
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This
announcement is distributed by West Corporation on behalf of West
Corporation 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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