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2016-01-29

Immunicum gives a status update from the ongoing phase II study (MERECA) in metastatic kidney cancer and reports significantly simplified vaccine cell handling

Immunicum AB
Company Announcement

Immunicum gives a status update from the ongoing phase II study (MERECA) in
metastatic kidney cancer and reports significantly simplified vaccine cell
handling

Gothenburg, Sweden, 2016-01-29 08:28 CET (GLOBE NEWSWIRE) --

Immunicum AB (publ) today reports a significantly improved vaccine cell
handling and gives a status update from the ongoing phase II study (MERECA)
with the cancer immune primer INTUVAX in patients with metastatic renal cell
carcinoma. Twelve patients have thus far been included in the study. So far, no
serious vaccine-related adverse events have been reported. Immunological data,
based on infiltration of CD8 + T cells in the tumors and in healthy tissue,
indicate a tumor-specific activation of the immune system in patients treated
with INTUVAX. Necessary regulatory approvals have now been obtained to begin
recruitment of patients in several European countries.

Immunicum today gave a status update from the ongoing phase II study, MERECA
(MEtastatic REnal cell CArcinoma) with INTUVAX in patients with newly diagnosed
metastatic renal cell cancer (NCT02432846). After approval from the Medical
Products Agency, the study was initiated in Sweden already in May 2015. Twelve
patients have been included in the study so far and several study-candidates
have been identified for screening. No serious vaccine-related adverse events
have been reported. Preliminary immunological data regarding the infiltration
of CD8 + T cells in primary tumors and in healthy tissue, as well as a
comparison between INTUVAX-treated patients and patients in the control group,
indicate a tumor-specific activation of the immune system in INTUVAX-treated
patients. Efficacy data is still too early to evaluate.

In parallel to production transfer to Eufets, a commercial GMP-certified
production site in Germany, Immunicum also completed a very important
adaptation of the manufacturing process. This work has on the one hand resulted
in a delay in the start of the phase II study outside of Sweden but on the
other hand generated a product that is ready for immediate use in the hospitals
without prior preparation at local pharmacies. By significantly simplified
handling of the vaccine cells, INTUVAX can in the future become available for
all European clinics. Immunicum is now ready to begin recruitment of patients
in several countries outside of Sweden.

- Efficacy data in the MERECA study is still too early to evaluate. However,
looking at the early analyses that have been done of the tissue samples
collected from the surgically removed kidneys, it looks very exciting so far.
We see a very distinct tumor-associated infiltration CD8+ T cells in the
examined tissue samples from the majority of patients receiving INTUVAX, says
Immunicum’s Chief Scientific Officer, Alex Karlsson-Parra.

- The development of INTUVAX as a direct injectable drug is very important as
it makes it possible for more clinics to take part in our studies today while
at the same time broadening the market in the future, if further studies show
good results. We now begin to treat patients outside of Sweden and expect that
patient recruitment will really take off. All 90 patients should be able to
include during this year, says Immunicum’s CEO Jamal El-Mosleh.

MERECA study design

Immunicum plans to include a total of 90 patients at 24 European centres in
eight countries (Czech Republic, Spain, France, Hungary, Latvia, Poland,
Sweden, and the UK). INTUVAX is injected in the primary tumor on two occasions
before a surgical removal of the kidney along with the primary tumor. Patients
will be randomized (randomly distributed) 2:1 between either INTUVAX in
combination with sunitinib or sunitinib alone administered about six weeks
after surgery. Sunitinib is a standard drug globally for treatment of renal
cancer.

The study is planned to include 60 % of patients with intermediate risk
prognosis and 40 % of patients with high-risk prognosis. Patients will be
monitored for 18 months, with the primary objective to evaluate median overall
survival in high-risk patients and 18-month survival rate in patients with
intermediate risk prognosis. Secondary objectives include evaluation of the
proportion of patients showing significant tumor reduction (evaluated by
computer tomography/CT), progression free survival, and evaluation of CD8+ T
cell infiltration in primary tumors (two separate areas), healthy kidney tissue
as well as in any evaluable metastases.

After an approved protocol amendment in Sweden, all patients treated with
INTUVAX will receive additional treatment with sunitinib starting six weeks
after surgery. The corresponding protocol amendment has been sent to relevant
local regulatory authorities in Europe. This is a change from the previous plan
to allow patients with intermediate risk prognosis to wait for add-on therapy
with sunitinib until CT-verified disease progression. The protocol amendment
was carried out to better reflect the procedure for standard treatment,
according to feedback from several clinics around Europe, and to more quickly
take advantage of the potential synergistic effect when INTUVAX is combined
with tyrosine kinase inhibitors that can suppress some of the inherent
immunosuppression existent in tumors.

The MERECA study was preceded by a phase I/II trial (IM-101) in 11
INTUVAX-treated patients with newly diagnosed metastatic renal cell cancer and
Immunicum now reports that six of the patients are still alive. The current
median overall survival in the phase I/II study has currently exceeded 32
months, compared to 15.2 months based on historical data for standard treatment
for the entire patient population and 28.2 months compared to 9.0 months based
on historical data for standard treatment for the subgroup with poor prognosis.

For further information please contact:

Jamal El-Mosleh, CEO, Immunicum

Telephone: +46 (0) 31 41 50 52
jamal.el-mosleh@immunicum.com

The Company’s Certified Adviser is Redeye AB

Telephone: +46 (0) 8 545 013 31. www.redeye.se

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
tumor-specific activation of the patient's cytotoxic T lymphocytes.

About Immunicum AB (publ)

Immunicum AB (publ) develops cancer immune primers for the treatment of tumor
diseases. A clinical phase II trial with 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).

www.immunicum.com

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