Idera Pharmaceuticals Announces Initiation of the ILLUMINATE-206 Trial Evaluating Tilsotolimod in Combination with Nivolumab ...
September 30 2019 - 7:30AM
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) announced today the
initiation of a phase 2 trial, ILLUMINATE-206 which will evaluate
tilsotolimod, a toll-like receptor 9 (TLR9) agonist, in combination
with nivolumab, a programmed death receptor-1 (PD-1) blocking
antibody, and ipilimumab, a human cytotoxic T-lymphocyte antigen 4
(CTLA-4) blocking antibody for the treatment of solid tumors.
The primary objective of this phase 2, open-label, global, study
is to demonstrate efficacy (measured by overall response rate [ORR]
based on RECIST v.1.1). Secondary and exploratory objectives
include safety, tolerability, immunogenicity and translational data
evaluations.
The initial cohort of the trial will be patients with
immunotherapy-naive Microsatellite Stable Colorectal Cancer
(MSS-CRC). The second planned cohort of ILLUMINATE-206 will
focus on treating patients with anti-PD(L)-1 refractory Squamous
Cell Carcinoma of the Head and Neck (RM-SCCHN), which will initiate
in the fourth quarter of this year.
“Initiation of this Phase 2 study is an important step toward
understanding the broader applications of tilsotolimod,” stated
Elizabeth A. Tarka, M.D., F.A.C.C., Idera’s Chief Medical
Officer. “Demonstrating the potential benefit of tilsotolimod
in patients with specific solid tumors where the disease setting
under investigation have no approved immunotherapies, would be a
significant contribution to the treatment paradigm.”
The basis for this trial is supported by data generated from the
ILLUMINATE-101 trial, which studied intratumoral tilsotolimod
monotherapy in 45 evaluable patients with a variety of solid tumor
types in which 33% (n=15) achieved stable disease.
Translational research in ILLUMINATE-101, demonstrated that
tilsotolimod increased dendritic cell activation and upregulated
MHC class II and IFN-α signaling which suggests improved antigen
presentation. These findings are consistent with those
observed in the ILLUMINATE-204 trial in anti-PD-1 refractory
metastatic melanoma patients. Therefore, the mechanism of action
for tilsotolimod may be tumor-type agnostic and potentially
beneficial in combination with checkpoint modulation in a variety
of tumor types.
A poster presentation from ILLUMINATE-101 is being presented at
the European Society for Medical Oncology (ESMO) 2019 Congress in
Barcelona, Spain today and can be found in the Key Publications
section of Idera’s Corporate website, www.iderapharma.com.
On March 11, 2019, Idera and Bristol-Myers Squibb (BMS) entered
into a clinical trial collaboration and supply agreement in which
BMS has agreed to supply YERVOY* (ipilimumab) and OPDIVO
(nivolumab) for no charge for use in ILLUMINATE-206.
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.
Idera 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 including statements regarding
our expectations for the ILLUMINATE-206 Trial. 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, 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 the further development of the Company’s
programs for the period anticipated; whether interim results from a
clinical trial, such as the preliminary 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 filings with the
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.
*Yervoy (ipilimumab) and Opdivo (nivolimumab) are registered
trademarks of Bristol-Myers Squibb.
Idera Pharmaceuticals Contact: Robert A. Doody,
Jr. SVP, Investor Relations & Communications Phone (484)
348-1677 rdoody@iderapharma.com
Idera Pharmaceuticals (NASDAQ:IDRA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Idera Pharmaceuticals (NASDAQ:IDRA)
Historical Stock Chart
From Apr 2023 to Apr 2024