Immunicum AB (publ) Completes Strategic Analysis and Defines Updated Clinical Development Plan for Ilixadencel
August 17 2017 - 2:00AM
Press Release
17 August 2017
Immunicum Completes Strategic Analysis and Defines Updated Clinical
Development Plan for Ilixadencel
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 the completion of an internal
strategic review process to define the next
phase of ilixadencel's clinical development program. Ilixadencel, formerly known as INTUVAX®, is an off-the-shelf
allogeneic cell-based therapy currently being investigated in an
ongoing Phase II trial in renal cell carcinoma (MERECA) as well as
Phase I/II studies in hepatocellular carcinoma and gastrointestinal
stromal tumor (GIST) patients. The review process was initiated in
the beginning of 2017 to evaluate the current therapeutic landscape
and ensure that the company's clinical development efforts are
strategically positioned to realize ilixadencel's full potential.
Based on the updated plan, the company is considering different
funding options to enable its implementation.
"An important part of effective
drug development is to be aware of how the therapeutic landscape
changes and adapts to incorporate new medical procedures and
innovative therapies into current treatment regimens," said Carlos
de Sousa, CEO of Immunicum. "We have a unique opportunity with
ilixadencel because of its broad applicability as a cell-based
therapy for treating many different types of cancer, therefore we
have developed our plan to maximize that potential, expand our
strategic options and increase the value of the program.
Ilixadencel has been designed to be a safe and effective backbone
that can be incorporated into current standard of care as well as
novel combination approaches."
The strategic review was conducted
by Immunicum's leadership team with the Board of Directors to
define the next phase of ilixadencel's clinical trial development
program. Overall, the plan seeks to increase the number of key
value inflection points by expanding the indications and regulatory
opportunities for the product. While the current trial programs in
renal cell carcinoma, hepatocellular carcinomas and GIST will
continue, the company will also, based on the present knowledge on
ilixadencel's safety profile, initiate additional clinical studies
that 1) incorporate the combination with additional immuno-oncology
drugs, such as checkpoint inhibitors, 2) explore indications with
high unmet medical need that could enable accelerated regulatory
review and 3) seek to continue to establish ilixadencel's potential
in the indications Immunicum is testing now. In addition, Immunicum
will start the Chemistry, Manufacturing and Controls (CMC)
commercial development activities required for initiation of a
pivotal trial for ilixadencel if the MERECA study results are
supportive.
Immunicum leadership will provide
further details about the next phase of clinical development and
its financing in its second quarter financial report and in
additional communications over the next several weeks.
About
ilixadencel
Ilixadencel cell therapy product (formerly known as
INTUVAX®) is an
off-the-shelf anti-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
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
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information contained therein.
Source: Immunicum AB via Globenewswire
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