Immunicum Announces Publication in Journal for ImmunoTherapy of Cancer of Results Overview from Ilixadencel's First Clinical ...
June 19 2017 - 8:01PM
Press Release
20 June 2017
Immunicum Announces Publication in
Journal for
ImmunoTherapy of Cancer of Results Overview from Ilixadencel's
First Clinical Study in Metastatic Renal Cell Carcinoma
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 results from the first
clinical study of ilixadencel in patients with newly diagnosed
metastatic renal cell carcinoma (mRCC) have been published in
the Journal for ImmunoTherapy
of Cancer. The results highlight
ilixadencel's potential as a novel add-on, immune priming treatment
for patients suffering from solid tumors based on its good safety
profile and initial indications of prolonged survival. Ilixadencel,
formerly known as INTUVAX, is currently in an ongoing Phase 2 trial
in renal cell carcinoma (MERECA) as well as Phase 1/2 studies in
hepatocellular cell carcinoma and gastrointestinal stromal
tumors.
"This publication represents the
complete analysis of data from the Phase 1/2 trial and we are
pleased to have achieved peer reviewed publication in a well
reputed international journal on all the elements of the trial.
These data provided the rationale for the ongoing Phase 2 MERECA
study," said Alex Karlsson-Parra, Chief Scientific Officer of
Immunicum. "Even though the study has been formally completed in
2014, we are still following the patients and are pleased to report
that as of May 2017, five out of 11 evaluable patients were still
alive and the mean overall survival is clearly favourable compared
to available historical data for the standard of care. One of the
five patients still alive, experienced a complete regression of all
brain and liver metastases, as noted in the publication. The
patient has also demonstrated a nearly total regression of lung
metastases and was metastasis-free following surgical removal of a
small remaining lung metastasis at the end of 2016. Although this
is only one case study, it is a promising initial result
considering the expected poor prognosis for these patients."
The Phase 1/2, first-in-human
study in twelve intermediate- and poor-risk patients with newly
diagnosed mRCC investigated safety as a primary endpoint and
reported on early signs of efficacy. The treatment regimen included
two consecutive intratumoral injections of ilixadencel within 2
weeks followed by nephrectomy and subsequent standard of care. The
study was initiated in January 2012 and formally completed in March
2014. Living patients are still followed to capture tumor response
and survival data. The results published in the current issue of
the Journal for ImmunoTherapy of Cancer
represent a summary of the trial and the survival follow-up as of
December 2016.
Ilixadencel showed a very good
safety profile with no severe adverse events related to the
treatment. Tumor-specific immune activation was indicated by
intratumoral infiltration of CD8+ T cells and an increase in
tumor-specific and interferon-gamma producing lymphocytes in
peripheral blood. Median overall survival for the 11 evaluable mRCC
patients was 42.5 months as of December 2016, which compares
favourably with existing historical data. As of late May 2017, five
of the patients that were enrolled in the study were still alive
and a final median overall survival of 48.0 months was reached.
"Apart from the good safety
profile, the data provided early indications that ilixadencel given
in conjunction with sunitinib could have a potential synergistic
antitumor effect, which we will be further investigating in the
ongoing MERECA trial," commented Alex Karlsson-Parra, Chief
Scientific Officer of Immunicum. "We believe that the future of
cancer treatment lies in the rapidly evolving landscape of
combination therapies and ilixadencel is uniquely positioned to
become an integral part of modern combination regimens."
Carlos de Sousa, Chief Executive
Officer of Immunicum added: "The publication represents the
committment to our strategy to communicate data through peer review
and therefore build validation for ilixadencel within the global
scientific and medical community. We strongly believe in the
potential of ilixadencel as an off-the-shelf immune primer in the
treatment of solid tumors and are focused on advancing its clinical
development to bring this therapy to patients."
The full publication titled
"Intratumorally injected pro-inflammatory allogeneic dendritic
cells as immune enhancers: A first-in-human study in unfavourable
risk patients with metastatic renal cell carcinoma" can be accessed
through the current online version of the Journal
for ImmunoTherapy of Cancer and the following link
http://dx.doi.org/10.1186/s40425-017-0255-0.
About renal cell cancer / carcinoma
There are
approximately 273,000 new cases of Renal Cell Cancer (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.
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 smay@macbiocom.com
The Company's Certified Adviser is Redeye
AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se
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 June 20, 2017 at 02.01 CET.
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
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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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