Idera Presents Preclinical Data Demonstrating Enhanced Systemic Anti-Tumor Activity from Combination Treatment with Intra-tum...
April 19 2016 - 7:30AM
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA
therapeutics for patients with cancer and rare diseases, today
announced new preclinical data demonstrating enhanced systemic
anti-tumor activity in preclinical cancer models with intra-tumoral
administration of IMO-2125 in combination with an inhibitor of the
immunosuppressive enzyme, indoleamine-pyrrole 2,3-dioxygenase
(IDO1). IMO-2125 is a synthetic oligonucleotide-based agonist
of Toll-like receptor 9 discovered and developed by Idera.
IDO is one of several immune checkpoints involved in tumor immune
escape. IDO-1 inhibitors are currently in clinical
development. These data are being presented at the AACR
Annual Meeting 2016 in New Orleans, LA.
“There is an extensive body of evidence which demonstrates that
modulating the tumor microenvironment is critical to a successful
outcome in cancer immunotherapy”, stated Sudhir Agrawal, D.Phil.,
President of Research at Idera Pharmaceuticals. “In
preclinical models, previously we have seen compelling systemic
anti-tumor effects with intra-tumoral IMO-2125 monotherapy, in
combination with inhibitors of CTLA-4, PD-1, and now, IDO.”
In the presentation, entitled “Creating the tumor
microenvironment for effective immunotherapy: Anti-tumor
activity of intra-tumoral IMO-2125, a TLR9 agonist is further
enhanced by inhibition of indoleamine-pyrrole 2,3-dioxygenase
(IDO),” Idera scientists presented data further supporting
the hypothesis that intra-tumoral IMO-2125 changes the tumor
microenvironment by increasing tumor-infiltrating lymphocytes
(TILs) and generating a favorable tumor microenvironment. Changes
in IDO checkpoint inhibitor expression were also
observed.
In the current studies, IMO-2125 (alone and in combination with
an IDO-1 inhibitor) increased TIL infiltration and decreased the
growth of treated and distant tumors, providing evidence of an
enhanced systemic antitumor immune response compared to either
agent given alone.
In the study we evaluated the antitumor activity of i.t.
IMO-2125 in combination with an IDO1 inhibitor in a murine
syngeneic colon carcinoma CT26 model. There was a
statistically significant decrease in the growth of both local and
distant tumors which was greater for combination therapy than for
either IMO-2125 or IDO-1 alone (for lung metastases: combination vs
IMO-2125: P = 0.0393; combination vs IDO-1 inhibitor: P =
0.0128).
These results and previous observations with IMO plus anti-CTLA4
and IMO plus PD-1 demonstrate that combination immunotherapy with
IMO-2125 has the potential to improve clinical outcomes over
currently available anti-CTLA4 and PD-1 inhibitors, and now IDO-1
inhibitors. These presentations are all currently available on
Idera’s website at
http://www.iderapharma.com/our-science/key-presentations-and-publications.
In partnership with the MD Anderson Cancer Center, the company
is currently conducting a Phase 1/2 clinical trial of intra-tumoral
IMO-2125 in combination with ipilimumab (CTLA4) for the treatment
of pembrolizumab (PD1) treated refractory metastatic melanoma
patients. The study has also recently been amended to include an
arm studying the combination of IMO-2125 and PD1 in the same
patient population.
About Toll-like Receptors and Idera's Immuno-Oncology
Research Program
Toll-like receptors (TLRs) are key components of the innate
immune system, the body's first line of defense against invading
pathogens, as well as damaged or dysfunctional cells including
cancer cells. The innate immune system is also involved in
activating the adaptive immune system, which marshals highly
specific immune responses to target pathogens or tissue. Cancer
cells may exploit regulatory checkpoint pathways to avoid being
recognized by the immune system, thereby shielding the tumor from
immune attack. Checkpoint inhibitors such as agents targeting CTLA4
or programmed cell death protein 1 (PD1) and, more recently, IDO
inhibitors work by targeting mechanisms of adaptive immune
resistance. It is believed that intra-tumoral administration
of IMO-2125 may potentiate the activity of all of these
immunotherapies by creating a more favorable tumor microenvironment
that includes increased infiltration by TILs.
Idera’s TLR9 agonist, IMO-2125 has been created using the
company's proprietary chemistry-based discovery platform.
IMO-2125 has been shown to activate dendritic cells and induce
interferon and other cytokines. Idera selected IMO-2125 to advance
into clinical development in combination with checkpoint inhibitors
based on this immunological profile. In preclinical studies
in cancer models, IMO-2125 has shown dose-dependent anti-tumor
activity in the injected tumor as well as in distant tumors.
Anti-tumor activity is associated with changes in the tumor
microenvironment, increased T-cell infiltration, and induction of
durable, tumor specific memory. In combination with
anti-CTLA4, anti-PD1, and IDO1 inhibitor, IMO-2125 has shown
greater anti-tumor activity than with either agent alone. In
previously completed clinical trials, subcutaneous administration
of IMO-2125 was generally well tolerated in about 80 patients with
hepatitis C.
About Idera Pharmaceuticals Idera
Pharmaceuticals is a clinical-stage biopharmaceutical company
developing novel nucleic acid-based therapies for the treatment of
certain cancers and rare diseases. Idera’s proprietary technology
involves using a TLR-targeting technology, to design synthetic
oligonucleotide-based drug candidates to act by modulating the
activity of specific TLRs. In addition to its TLR programs, Idera
has created a third generation antisense technology platform using
its proprietary technology to inhibit the production of
disease-associated proteins by targeting RNA. To learn more about
Idera, visit www.iderapharma.com.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, including
statements about potential treatments for cancer employing
combinations of drug therapies including Idera’s IMO-2125 with
resistance modulators such as CTLA4, PD1 and IDO1. Such
statements may be identified by words such as "believe," "expect,"
"may," "plan," "potential," "will" and similar expressions, and are
based on the company’s current beliefs and expectations.
Development of drug therapies involves a high degree of risk, and
only a small percentage of research and development programs
undertaken may result in the commercialization of a product.
Positive preclinical data does not ensure that later stage clinical
trials will be successful. For more detailed information on
the risks and uncertainties associated with Idera’s development
activities, please review the Risk Factors section of Idera's most
recent annual or quarterly or annual report filed with the
Securities and Exchange Commission. Any forward-looking statements
speak only as of the date of this press release and the company
assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor and Media Contact
Robert Doody
VP, IR & Corporate Communications
617-679-5515 (office)
484‐639‐7235 (mobile)
rdoody@iderapharma.com
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