Idera Pharmaceuticals, Inc. (“Idera”) (Nasdaq: IDRA) today
announced that final data from the ILLUMINATE-204 trial
investigating intratumoral tilsotolimod, Idera’s investigational
Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini
Oral presentation at the European Society for Medical Oncology
(ESMO) Virtual Congress 2020, to be held September 19-21, 2020. In
addition, final results from ILLUMINATE-101 will be shared in a
poster presentation.
ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in
patients with anti-PD-1 refractory advanced melanoma. The phase 1
portion of the trial tested the safety and efficacy of increasing
doses of tilsotolimod in combination with either Yervoy®*
(ipilimumab) or Keytruda®† (pembrolizumab). The phase 2 expansion
of the trial enrolled additional patients at the recommended phase
2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy®,
which is the treatment regimen being evaluated for the same
indication in the Company’s registrational trial, ILLUMINATE-301.
Adi Diab, M.D., of The University of Texas MD Anderson Cancer
Center, will be delivering the Mini-Oral presentation as part of
the Mini Oral Session on Melanoma and Other Skin Tumors.
ILLUMINATE-101 is a phase 1b trial evaluating intratumoral
tilsotolimod monotherapy in patients with refractory solid tumors,
which was completed in December 2019. Final results for
ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the
University of Arizona Cancer Center.
In addition to presentations on these Idera-sponsored trials,
AbbVie will be presenting a trial-in-progress poster on their phase
1b study to determine the safety, tolerability, pharmacokinetics,
and preliminary efficacy of combinations of ABBV-368 plus
tilsotolimod in subjects with recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC). This trial is being conducted as
part of an immuno-oncology clinical research collaboration between
Idera and AbbVie.
The presentation titles are as follows:
- 1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of
Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1
Inhibitor Refractory Advanced Melanoma
- 1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen
Presentation and Type I IFN Signaling in Solid Tumors
- 975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in
Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in
Patients With Recurrent/Metastatic Head and Neck Squamous Cell
Carcinoma
The on-demand poster and oral presentations will be available
beginning on Thursday, September 17 and Friday, September 18,
respectively.
“We are very pleased that Dr. Diab will present final data from
our phase 2 trial exploring tilsotolimod plus ipilimumab in
advanced melanoma patients,” stated Elizabeth Tarka, M.D., Idera’s
Chief Medical Officer. “We are looking forward to completing our
registrational trial for this indication, ILLUMINATE-301, where a
comparator arm is included, and moving this potential therapy one
step closer to those patients in need.”
Idera also announced that the company will present at the H.C.
Wainwright 22nd Annual Global Investment Conference on Tuesday,
September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera’s
presentation will be accessible in the Investor Relations section
of Idera’s website at www.iderapharma.com.
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 and adaptive 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 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 and
costimulation therapies. For more information on tilsotolimod
trials, please visit ClinicalTrials.gov.
About Idera Pharmaceuticals
Harnessing 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
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, plans, and objectives of management, are forward-looking
statements. The words "believes," "expects," "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 Annual Report filed on
Form 10-K for the period ended December 31, 2019. 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.
*Yervoy (ipilimumab) is a registered trademark of Bristol Myers
Squibb Company.
†Keytruda (pembrolizumab) is a registered trademark of Merck
Sharp & Dohme Corp.
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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