Idera Pharmaceuticals Announces Corporate Updates
May 18 2021 - 4:15PM
Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today announced that it will not continue ILLUMINATE-301, the
Company’s trial of tilsotolimod in combination with ipilimumab
versus ipilimumab alone in patients with anti-PD-1 refractory
advanced melanoma, to its overall survival (OS) primary endpoint.
The Company reported in March 2021 that the trial did not meet its
primary endpoint of objective response rate (ORR). Full results
from the study will be presented in a future publication.
“Since receiving the disappointing ORR results from
ILLUMINATE-301, we have interrogated the full data set and
consulted with our study Steering Committee, our partners at
Bristol Myers Squibb (BMS), and other stakeholders regarding next
steps for the trial. Our conclusion is that the totality of the
data, with all patients having completed the study treatment, does
not support the likelihood that the combination of tilsotolimod
with ipilimumab would achieve a statistically significant OS
benefit over ipilimumab alone,” stated Vincent Milano, Idera’s
Chief Executive Officer. “I want to personally thank all the
patients and investigators for their dedication to the study.”
Added Mr. Milano, “We remain committed to our additional trials
and are continuing to enroll and treat patients in ILLUMINATE-206,
our Phase 2 study of tilsotolimod in combination with BMS’s
nivolumab and ipilimumab for patients with microsatellite-stable
colorectal cancer and to support AbbVie in the form of study drug
in their trial for patients with head and neck squamous cell
carcinoma.”
Continued Mr. Milano, “As we turn our attention toward the
future, we continue to be active in our goal to identify and secure
new development or commercial-stage assets. We have an exceptional
team with a strong track record and passion for helping patients
that I believe can be beneficial in delivering results from
promising compounds.”
The Company is also announcing that Elizabeth Tarka, M.D., the
Company’s Chief Medical Officer since July 2019, will be leaving
the Company on May 28, 2021. Dr. Tarka will continue working with
Idera on a consulting basis.
“I want to thank Liz for helping us deliver ILLUMINATE-301 and
for her many other contributions over the past two years,” stated
Mr. Milano. “We wish her all the best in her future endeavors.”
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. All statements,
other than statements of historical fact, included or incorporated
in this press release, including statements regarding the Company's
strategy, financial position, funding for continued operations,
cash reserves, 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,"
“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 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 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 the impact of public health
crises, including the novel coronavirus (COVID-19) global pandemic.
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, 2020, 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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