Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the “Company”) today
announced preliminary data from the first 10 patients in the safety
cohort of ILLUMINATE-206, a Phase 2, open-label, multi-center
study to evaluate tilsotolimod in combination with Opdivo®
(nivolumab) and Yervoy®* (ipilimumab) in immunotherapy-naive
micro-satellite stable colorectal cancer (MSS-CRC) patients. Based
on data to date, the Company plans to expand the study to further
evaluate this triplet combination in MSS-CRC.
To investigate the safety profile of this triplet combination,
ILLUMINATE-206 was designed with a stepwise approach to Yervoy®
dosage. Patients in this initial safety cohort of the study, many
of whom were heavily pre-treated and rapidly progressing, received
8 mg of intratumoral tilsotolimod and 3 mg/kg of intravenous (IV)
Opdivo® every 2 weeks, along with 1 mg/kg of IV Yervoy® every 8
weeks. This regimen was generally well tolerated; no patients
discontinued treatment due to adverse events (AEs) and none
experienced Grade 4 or 5 AEs. One patient experienced stable
disease per RECIST v1.1 criteria, and 9 patients progressed as
defined by RECIST v1.1. Investigators reported that 6 of the
progressing patients had stability or reduction in size of injected
lesions and 6 had stability or reduction in overall size of
uninjected lesions.
Based on these results, the Company plans to enroll additional
patients in this MSS-CRC cohort of ILLUMINATE-206. Planned changes
in the study design intended to improve potential outcomes in this
patient population include increasing the frequency of Yervoy®
dosing and limiting the number of allowed prior lines of treatment
to two or fewer. Enrollment of the next 10 patients is targeted to
begin in the fourth quarter of 2020, with data anticipated in the
second quarter of 2021. Pending data from those patients, the trial
may be expanded further.
“We are encouraged by the initial safety profile of this
first-time triplet combination,” stated Elizabeth A. Tarka, M.D.,
Idera’s Chief Medical Officer. “We look forward to continuing to
explore the potential clinical benefit of tilsotolimod in
combination with ipilimumab and nivolumab in MSS-CRC, possibly
yielding a treatment alternative for these patients with few
current options.”
For more information about ILLUMINATE-206, visit
www.ClinicalTrials.gov.
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. 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 received Fast Track Designation from the U.S. Food
and Drug Administration (FDA) for the treatment of anti-PD-1
refractory melanoma, in combination with ipilimumab, as well as
Orphan Drug Designation for the treatment of stage IIb-IV melanoma.
It 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 MSS-CRC Colorectal 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.” According to the American Cancer Society
and other references, annually in the United States, approximately
140,000 people are diagnosed with CRC, of which 85% are MSS, and
approximately 50,000 deaths are attributed to CRC. MSS-CRC has been
shown to be highly immunosuppressive; there are no approved
immunotherapy options, and a prior trial of Yervoy® plus Opdivo®
(Bristol Myer Squibb’s CheckMate 142) yielded overall response
rates of 0-10%. Given tilsotolimod’s mechanism of action of
activating dendritic cells, it may serve a complementary function
to Yervoy® and Opdivo® 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 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, financial
position and clinical trial plans, including enrollment and 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, 2019, 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.
*Opdivo (nivolumab) and Yervoy (ipilimumab) are registered
trademarks of Bristol Myers Squibb.
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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