Press Release
28 September 2017
Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical
Study --Topline Safety and Immune Response Data Support Continued
Development of Ilixadencel in Liver Cancer--
Immunicum AB
(publ; First North Premier: IMMU.ST) a biopharmaceutical company
advancing a novel immune-priming cancer treatment against a range
of solid tumors, today announced positive topline results from the
completed Phase I/II safety and tolerability clinical trial of lead
drug candidate, ilixadencel, in 18 advanced liver cancer patients.
Ilixadencel was shown to be safe and well tolerated in these
patients when given both as a single treatment and in combination
with the current first line standard of care treatment, sorafenib.
In addition, the results provide evidence of tumor-specific immune
activation in the majority of patients. Based on these positive
data, Immunicum continues preparation for the next stage of
clinical development, in which one focus
will be on establishing ilixadencel's
efficacy in treating liver cancer. Ilixadencel is a cell-based,
off-the-shelf therapy designed to prime the
patient's immune system to recognize and destroy cancer cells,
overcoming the tumor cell's ability to avoid immune system
detection and attack.
Advanced liver cancer,
specifically metastatic hepatocellular carcinoma (HCC) and
cholangiocarcinoma (CCA, also known as bile duct cancer), is an
aggressive and difficult to treat form of cancer with high
mortality rates and short time to death*. Currently available
treatment options including chemotherapy, molecular targeted
therapy, local interventional hepatic therapy or surgery, have
limited impact in patients with advanced disease. These treatments
are also constrained because liver cancer patients have low
tolerance for treatments with high levels of toxicity. Priming the
immune system to attack a tumor holds promise of offering increased
therapeutic impact with reduced side effects.
Study
Design
This was a single arm, open-label, Phase I/II trial including 18
patients with advanced liver cancer, 17 patients with mHCC and 1
patient with advanced CCA**. Patients were to be treated with three
separate injections of ilixadencel directly into their primary
tumor (at approximately Day 1, 14 and 42) and patients were
followed for 6 months after last injection. The primary objective
was to investigate safety and tolerability for ilixadencel in HCC
as second line therapy for patients not responding to previous
treatments, or first line therapy administered with or without
sorafenib. The secondary objectives included several exploratory
endpoints including immunological response as measured by systemic
levels of tumor specific T cells as well as initial signs of
clinical activity. The study was conducted in Sweden at the
Sahlgrenska University Hospital, Gothenburg. (clinicaltrials.gov
ID: NCT01974661)
The final patient disposition was
as follows: 7 patients were treated with ilixadencel as second line
treatment, 10 patients were treated as first line treatment of
which 6 patients were treated in combination with sorafenib. 14
patients received all three injections.
Results - Safety
There were no life-threatening or
fatal treatment-related adverse events (AEs). Overall, with only
one exception, all treatment-related AEs were mild-to-moderate in
Common Terminology Criteria for Adverse Events grading (grade 1 -
2). The most common treatment-related AEs were described as fever
and/or chills and could be easily managed. The exception was one
patient receiving ilixadencel and sorafenib as combination therapy,
who presented with a suspected sepsis event (grade 3) that
subsequently recovered. As a reference, current standard of care,
such as sorafenib or regorafenib, report in the literature and in
prescribing information severe (grade 3) drug-related AEs in at
least one in three HCC patients treated.
"The most important results of
this phase of clinical development are the safety data and these
provide us with a solid basis on which to continue testing
ilixadencel as a potential treatment for advanced liver cancer, an
indication with desperate need of additional therapies," said Peter
Suenaert, MD, PhD, Chief Medical Officer at Immunicum. "The final
topline results remain in line with our previously reported data,
and we are very excited to conclude the study with this outcome. We
look forward to the opportunity to publish the final data analysis
from the study in a peer-reviewed scientific journal."
Results - Main
Exploratory Endpoints
Evidence of systemic immunological response to the treatment, as
measured by an increase in tumor-specific, interferon-gamma
producing CD8+ T cells in the blood, was demonstrated in 9 out of
13 evaluable patients (69%). Overall survival ranged between 1.6 -
21.4 months in the total group of 17 HCC patients at closure of
study with three patients still alive. More in-depth group and
patient analyses are ongoing and will be included in a future
scientific journal publication.
"The excellent safety observed in
this trial, as in previous studies, support our overall strategy
for ilixadencel as a possible backbone in solid tumor cancer
treatment that can prime the immune system while being safe and
well tolerated by patients. Beyond the safety profile, the
immunological data confirm our mechanism of action and support our
plans to move ilixadencel forward in HCC, an important part of our
clinical development strategy," said Carlos de Sousa, MD, CEO of
Immunicum. "We thank our clinical development team, the clinicians,
the patients and their families involved in the study for their
support."
* Bruix J et al. Regorafenib for
patients with hepatocellular carcinoma who progressed on sorafenib
treatment (RESORCE): a randomised, double-blind,
placebo-controlled, phase 3 trial; The Lancet Published online
December 5, 2016
**Inclusion approved by the Swedish regulatory authorities
(MPA)
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.
About Phase I/II
clinical trials
A Phase I clinical study is the first time a new treatment is
administered to humans. The purpose of the first clinical trials is
to determine whether the study subjects tolerate the drug and
whether it behaves in the body in the way as indicated based on
animal studies and other pre-clinical research. In cancer drug
development, the study subjects are most often cancer patients
whose disease is in an advanced stage and for whom not many other
therapeutic options exist. The product is administered under strict
medical conditions and the patients are followed up intensely.
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 agency of the company's
contact person on September 28, 2017 at 8:00 am CET.
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 + 49 175 571 1562
E-mail: gschweitzer@macbiocom.com or smay@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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