LOS ANGELES and HOUSTON, March 23,
2017 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd.
("ImmunoCellular") (NYSE MKT: IMUC) and Memgen, LLC ("Memgen")
announce the signing of a non-binding letter of intent to
exclusively negotiate the terms to possibly establish an
immuno-oncology strategic collaboration focused on conducting
clinical trials combining the companies' respective cancer
immunotherapy product candidates. The discussions pertain to
ImmunoCellular's dendritic cell (DC)-based immunotherapy product
candidates, ICT-107 and ICT-140, and Memgen's ISF35, a viral cancer
immunotherapy encoding an optimized version of CD40 ligand.
Combining DC-based and viral oncology immunotherapeutic approaches
could provide a novel way to stimulate CD40 to possibly induce a
potent, specific and effective anti-tumor response. Insights from
these combination trials, if successful, could also lead to later
combination trials with other immune-oncology technologies,
including checkpoint inhibitors.
"We are excited about the potential to work with Memgen," said
Anthony Gringeri, PhD,
ImmunoCellular President and Chief Executive Officer. "Memgen's
viral cancer immunotherapy, ISF35, has the potential to enhance the
activity of ImmunoCellular's immuno-oncology product candidates,
including ICT-107. The ability to stimulate CD40 with a viral
vector could play an important role in increasing the efficacy of
dendritic cell immunotherapies. We look forward to potentially
testing these therapies in combination trials."
"We're very pleased to have the opportunity to work with
ImmunoCellular Therapeutics and its DC product candidates,
including ICT-107 in glioblastoma," said Mark Cantwell, PhD, Memgen Chief Scientific
Officer. "Preclinical research presented at the 2016 American
Association of Cancer Research (AACR) Annual Meeting showed that
ISF35 in combination with checkpoint inhibitors induces anti-tumor
immune responses, expands tumor specific CD8 T cells, and has the
potential to eradicate brain tumors. The combination of ISF35 and
ICT-107 with checkpoint inhibitors may provide a multi-pronged
antitumor immune response. This includes ISF35's CD40-driven
dendritic and T cell activation and expansion, ICT-107's
tumor-specific antigen presentation, and checkpoint inhibitor
release of the PD-1 pathway-mediated inhibition of the antitumor
immune response."
If the parties agree upon the terms of a strategic
collaboration, including financials, development, supply and
control, ImmunoCellular and Memgen plan to work together to
determine the best clinical strategy to leverage the
collaboration.
About ICT-107 and ICT-140
ICT-107 is a dendritic cell-based immunotherapy targeting six
tumor-associated antigens on glioblastoma stem cells. ICT-107 is
currently being tested in a phase 3 registration trial in patients
with newly diagnosed glioblastoma. The ongoing phase 3
registrational trial of ICT-107 is designed as a randomized,
double-blind, placebo-controlled study of HLA-A2+ subjects, which
is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize 542
patients with newly diagnosed glioblastoma. The primary endpoint in
the trial is overall survival. Secondary endpoints include
progression-free survival and safety, as well as overall survival
in the two pre-specified MGMT subgroups.
For patients, families and physicians seeking additional
information about the ICT-107 phase 3 trial, please consult
www.clinicaltrials.gov.
ICT-140 is a dendritic cell-based immunotherapy targeting seven
tumor-associated antigens expressed on ovarian cancer cells.
ImmunoCellular plans to conduct a phase 2 clinical trial in
patients with ovarian cancer, pending available resources.
About ISF35
ISF35 is a viral cancer immunotherapy encoding an optimized form
of CD40 ligand. Direct intratumoral delivery of ISF35, a
non-replicating adenovirus encoding CD40 ligand, activates
tumor-specific T cells through immunostimulation of dendritic
cells. ISF35 generates an effective anti-tumor immune response and
complements checkpoint inhibitors, a class of immuno-oncology (IO)
drugs that removes the brakes tumors attempt to use to stop a T
cell anti-tumor immune response.
Preclinical studies have shown that ISF35 in combination with
checkpoint inhibitors cures 40% of mice with an aggressive B16
melanoma tumor, and eradicates melanoma brain metastases. These
data add to the extensive clinical experience of ISF35 in chronic
lymphocytic leukemia where safety and activity have been
demonstrated. Preclinical research evaluating ISF35 in combination
with PD-1, PD-L1, and CTLA-4 checkpoint inhibitors is guiding the
clinical development of ISF35
About Memgen
Memgen is a clinical-stage biotech company whose mission is to
substantially improve cancer patient survival with our viral cancer
immunotherapies. Memgen's lead product, ISF35, is a first-in-class,
viral cancer immunotherapy encoding an optimized version of CD40
ligand. ISF35 is being combined with checkpoint inhibitors, and
other drug classes, to potentially treat a broad range of cancer
types, including but not limited to bladder cancer, metastatic
melanoma, lymphoma, lung cancer, and hepatocellular carcinoma.
Clinical trial protocols for these indications are ready for
clinical collaboration. ISF35 has worldwide patent protection,
qualifies for twelve years of US biologics marketing exclusivity,
and has received orphan drug designation for advanced melanoma. To
learn more about Memgen, please visit www.memgenbio.com.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that
is developing immune-based therapies for the treatment of brain and
other cancers. The Company's lead product candidate, ICT-107, is a
patient-specific, dendritic cell-based immunotherapy targeting
glioblastoma and is currently being studied in an international
phase 3 trial. ImmunoCellular's pipeline also includes: ICT-121, a
patient-specific, dendritic cell-based immunotherapy targeting
CD133 found in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based immunotherapy targeting ovarian cancer; and
the Stem-to-T-cell research program which engineers hematopoietic
stem cells to generate cytotoxic T cells. To learn more about
ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements,
including statements regarding whether the parties are able to
reach agreement on terms of a collaboration, the potential for
success of any collaboration, the financial requirements to enable
a collaboration and impact on the parties in a collaboration; the
timing for collaborative development efforts, including among other
things, timing for enrollment and randomization of patients, the
activation of clinical sites, the receipt and announcement of
clinical data; and the ability of the parties to achieve clinical,
operational and financial goals from the collaboration.
Forward-looking statements are not guarantees of future performance
and are subject to a number of risks and uncertainties, including
the availability of resources to continue to develop
ImmunoCellular's product candidates, the uncertain timing of
completion and success of clinical trials, and the risk that
ICT-107 can be further successfully developed or commercialized.
Additional risks and uncertainties are described under the heading
"Risk Factors" in ImmunoCellular's most recently filed quarterly
report on Form 10-Q for the period ended September 30, 2016. Except as required by law,
ImmunoCellular undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts:
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ImmunoCellular
Therapeutics, Ltd.
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Memgen,
LLC
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Investor
Relations
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Business
Development
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Jane Green
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bizdev@memgenbio.com
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415.652.4819
mobile
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jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.