Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the “Company”) today is
announcing that ILLUMINATE-301, the Company’s pivotal registration
trial of tilsotolimod in combination with ipilimumab versus
ipilimumab alone in patients with anti-PD-1 refractory advanced
melanoma, did not meet its primary endpoint of objective response
rate (ORR). Idera is evaluating its next steps regarding
continuation of the trial toward its overall survival (OS)
endpoint, which includes evaluating the full data set when it is
available. The Company also plans to continue its ILLUMINATE-206
Phase 2 study of tilsotolimod in combination with ipilimumab and
nivolumab in patients with microsatellite stable colorectal cancer
(MSS-CRC).
ILLUMINATE-301 is a randomized, global, multi-center, open label
Phase 3 trial comparing the efficacy of 8 mg intratumoral
tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg
ipilimumab alone in 481 patients with anti-PD-1 refractory advanced
melanoma. The trial has a primary endpoint family of ORR per RECIST
v1.1 and OS. Although the primary endpoint of ORR was not met, if
the study continues and reaches a positive OS outcome, the Company
would expect to discuss with regulatory authorities a potential
path forward in this indication.
ILLUMINATE-301 Key Findings: Patients in the
study were randomized and treated either with 8 mg of tilsotolimod
in combination with ipilimumab or with ipilimumab alone. Topline
results include:
- ORR of 8.8% for the combination arm and 8.6% for ipilimumab
alone.
- Disease control rate (DCR, defined as stable disease or better)
of 34.5% for the combination and 27.2% for ipilimumab alone.
- Treatment-emergent adverse events (TEAEs) (Grade 3 and above)
occurred in 61.1% of patients who received the combination vs.
55.1% of patients who received ipilimumab alone. Immune-related
TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%,
respectively.
More detailed results from ILLUMINATE-301 may be submitted for
future publication or presentation.
“We are surprised and disappointed that the response data from
ILLUMINATE-301 do not lead us to an accelerated path to a new and
much-needed treatment option for these patients,” stated Vincent
Milano, Idera’s Chief Executive Officer. “We would like to extend
our deepest gratitude to everyone involved in this study,
especially the many courageous patients who participated and
continue in follow up.”
Continued Mr. Milano, “Despite today’s news, we are continuing
to explore tilsotolimod via our ongoing ILLUMINATE-206 study in
order to understand its potential to lead to better outcomes for
patients with MSS-CRC.”
About Tilsotolimod (IMO-2125)Tilsotolimod is an
investigational, synthetic Toll-like receptor 9 agonist.
Intratumoral injection of tilsotolimod has been shown to promote
both innate (Type-I IFN, antigen presentation) and adaptive (T
cells) immune activation. Tumors with an active immune response
appear to respond better to checkpoint inhibitors (CPIs) than those
that exclude or inhibit anti-tumor immune cells. Tilsotolimod in
combination with CPIs may increase the number of patients who
benefit from immunotherapy.
Tilsotolimod has received both Fast Track designation and Orphan
Drug designation from the FDA and is being evaluated in multiple
tumor types and in combination with multiple checkpoint inhibitors.
For more information on tilsotolimod trials, please visit
www.clinicaltrials.gov.
About Anti-PD-1 Refractory Advanced
MelanomaMelanoma is a cancer that begins in a type of skin
cell called melanocytes. While melanoma is the least common type of
skin cancer, it has a poor prognosis when not detected and treated
early. As is the case in many forms of cancer, melanoma becomes
more difficult to treat once the disease has spread, or
metastasized, beyond the skin to other parts of the body. According
to the American Cancer Society, approximately 100,000 people in the
US will be diagnosed with invasive melanoma this year. In recent
years, immunotherapies known as CPIs have changed the treatment of
advanced melanoma, with anti-PD-1 agents, alone or in combination
with anti-CTLA-4, being the most commonly used immunotherapy in the
first-line setting. These agents work by increasing the ability of
the body’s immune system to help detect and fight cancer cells.
However, due to primary or acquired resistance mechanisms that
exclude or inhibit anti-tumor immune cells, as many as 60% of
patients may not benefit from this type of therapy when used as
monotherapy, and up to one-third of initial responders may develop
resistance to the therapy and ultimately experience disease
progression. Today, these refractory patients are left with few
options for further treatment, paving the way for novel
investigational therapies such as tilsotolimod.
About MSS-CRCColorectal cancer involves the
abnormal growth of cells in the colon or rectum. This type of
cancer is typically tested to determine its “MSI” status, which
will inform treatment approach and prognosis. MSI stands for
“microsatellite instable.” MSI-High (MSI-H) means that there is a
high amount of instability in a tumor, whereas MSS tumors are
“microsatellite stable.” The American Cancer Society estimates
that, annually in the United States, approximately 140,000 people
are diagnosed with CRC, of which 85% are MSS, and approximately
50,000 people die due to CRC. MSS-CRC has been shown to be highly
immunosuppressive; there are no approved immunotherapy options, and
a prior trial of ipilimumab plus nivolumab (Bristol Myers Squibb’s
CheckMate 142) yielded overall response rates of 0-10%. Given
tilsotolimod’s mechanism of action of activating dendritic cells
and therefore triggering innate and adaptive immune responses, it
may serve a complementary function to ipilimumab and nivolumab
within the immunosuppressive tumor microenvironment of MSS-CRC
patients.
About Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and the
company’s vast experience in developing proprietary immunology
platforms, Idera’s development program is focused on priming the
immune system to play a more powerful role in fighting cancer,
ultimately increasing the number of people who can benefit from
immunotherapy. Idera also continues to focus on the acquisition,
development, and ultimate commercialization of drug candidates for
both oncology and rare disease indications characterized by small,
well-defined patient populations with serious unmet needs. To learn
more about Idera, visit www.iderapharma.com.
Forward-Looking Statements This 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. All statements,
other than statements of historical fact, included or incorporated
in this press release, including statements regarding the Company's
strategy, future operations, collaborations, intellectual property,
cash resources, financial position, future revenues, projected
costs, prospects, clinical trials and related endpoints, plans, and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," "continue," "will," and "would" and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company's
forward-looking statements. There are a number of important factors
that could cause Idera's actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether the
Company’s cash resources will be sufficient to fund the Company’s
continuing operations and further development of the Company’s
programs for the period anticipated; whether topline results from a
clinical trial, such as the results reported in this release, will
be predictive of the final results of the trial; whether results
obtained in preclinical studies and clinical trials such as the
results described in this release will be indicative of the results
that will be generated in future clinical trials, including in
clinical trials in different disease indications; whether products
based on Idera's technology will advance into or through the
clinical trial process when anticipated or at all or warrant
submission for regulatory approval; whether such products will
receive approval from the U.S. Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if the Company's
products receive approval, they will be successfully distributed
and marketed; whether the Company's collaborations will be
successful; and such other important factors as are set forth under
the caption "Risk Factors" in the Company’s Annual Report filed on
Form 10-K for the period ended December 31, 2020 and in the
Company’s other filings with the Securities and Exchange
Commission. Although Idera may elect to do so at some point in the
future, the Company does not assume any obligation to update any
forward-looking statements and it disclaims any intention or
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Idera Pharmaceuticals Contacts:
Jill Conwell
Investor Relations &
Corporate Communications
Phone (484) 348-1675
JConwell@IderaPharma.com
John J. Kirby
Chief Financial Officer
Phone (484) 348-1627
JKirby@IderaPharma.com
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