Idera Pharmaceuticals Completes Enrollment in ILLUMINATE-301, its Registrational Trial of Tilsotolimod in Combination with Ip...
March 05 2020 - 7:00AM
Idera Pharmaceuticals, Inc. (“Idera” or “the company”) (NASDAQ:
IDRA) today announced completion of patient enrollment into
ILLUMINATE-301, its registrational trial of tilsotolimod in
combination with ipilimumab in patients with anti-PD-1 refractory
advanced melanoma. The company expects to announce top-line overall
response rate (ORR) and other preliminary data from ILLUMINATE-301
in Q1 2021.
“We are making outstanding progress in moving toward our goal of
delivering tilsotolimod to the market in our lead indication for
anti-PD-1 refractory advanced melanoma patients,” stated Vincent
Milano, Idera’s Chief Executive Officer. “We achieved this critical
milestone earlier than anticipated, which we believe is truly a
testament to the high unmet need facing these patients.”
Added Elizabeth Tarka, M.D., Idera’s Chief Medical Officer, “We
believe tilsotolimod in combination with ipilimumab may be an
important new therapeutic option for these patients, and we are
incredibly grateful to them, their families, and our investigators
for their participation in ILLUMINATE-301. We look forward to
sharing the results of this exciting trial soon.”
ILLUMINATE-301 is a randomized, phase 3 trial comparing the
effectiveness of intratumoral tilsotolimod in combination with
ipilimumab with ipilimumab alone in patients with anti-PD-1
refractory advanced melanoma, with a primary endpoint family of ORR
per RECIST v1.1 and overall survival (OS). Key secondary
endpoints include durable response rate, time to response,
progression-free survival, patient-reported outcomes, and safety.
ILLUMINATE-301 enrolled 481 patients across 80 sites in 11
countries.
About Anti-PD-1 Refractory Advanced
MelanomaMelanoma is a cancer that begins in a type of skin
cell called melanocytes. While melanoma is one of the least common
types 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, pioneering immunotherapies known as checkpoint inhibitors
(CPIs) have changed the treatment of advanced melanoma and have
become the standard of care, with anti-PD-1 agents 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 do not benefit from this type of
therapy, and up to one-third of initial responders 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
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
CPIs than those that exclude or inhibit anti-tumor immune cells.
Thus, tilsotolimod in combination with CPIs may cause regression of
locally injected and distant tumor lesions and 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 Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and the
company’s vast experience in developing proprietary immunology
platforms, Idera’s lead 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 StatementsThis
press release contains forward-looking statements within the
meaning of the safe harbor of the Private Securities Litigation
Reform Act of 1995 and the Federal securities laws. All statements,
other than statements of historical fact, included or incorporated
in this press release, including statements regarding the Company's
strategy, and clinical trial plans, including timing of results,
are forward-looking statements. The words "believes,"
"anticipates," "estimates," "plans," "expects," "intends," "may,"
"could," "should," "potential," "likely," "projects," "continue,"
"will," “schedule,” and "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements are predictions based on the Company’s
current expectations and projections about future events and
various assumptions. 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. These forward-looking
statements involve known and unknown risks, uncertainties, and
other factors, which may be beyond Idera’s control, and which may
cause the actual results, performance, or achievements of the
Company to be materially different from future results,
performance, or achievements expressed or implied by such
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
including, without limitation: whether the Company’s cash resources
will be sufficient to fund the Company’s continuing operations and
the further development of the Company’s programs; whether interim
results from a clinical trial will be predictive of the final
results of the trial; whether results obtained in preclinical
studies and clinical trials 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 FDA or equivalent foreign regulatory agencies; whether, if
the Company's products receive approval, they will be successfully
distributed and marketed; and whether the Company's collaborations
will be successful. All forward-looking statements included in this
release are made as of the date hereof, and are expressly qualified
in their entirety by this cautionary notice, including, without
limitation, those risks and uncertainties described in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2018, and otherwise in the Company’s filings and reports filed
with Securities and Exchange Commission. While 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, except as may be required by law.
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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