Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that the
U.S. Patent and Trademark Office has issued U.S. Patent No.
10,772,907 (the ‘907 Patent) and allowed U.S. Patent Application
No. 16/557,597 (the ‘597 Application), both entitled “Immune
Modulation with TLR9 Agonists for Cancer Treatment” and each of
which includes the Company’s investigational therapy tilsotolimod.
The new patent and allowed application each include 26 claims
directed to methods of treating colorectal cancer (CRC) (the ‘907
Patent) and head and neck squamous cell carcinoma (HNSCC) (the ‘597
Application) with intratumoral administration of tilsotolimod in
combination with certain immune checkpoint inhibitor therapies,
including CTLA-4, PD-1 or PD-L1 proteins. This new coverage expands
protection of the first tilsotolimod method-of-use patent, which
was directed to methods of treating metastatic melanoma and was
issued in November 2019. The patents and the allowed application
provide exclusivity for certain uses of tilsotolimod through
September 2037.
“The CRC patent and the soon-to-issue HNSCC patent fortify our
‘beyond melanoma’ strategy for tilsotolimod, which currently
includes ongoing development in MSS-CRC via our ILLUMINATE-206
trial and in HNSCC via our collaboration with AbbVie,” said Vincent
Milano, Idera’s Chief Executive Officer. “These additional new
intellectual property protections also demonstrate our commitment
to tilsotolimod and to furthering its development potentially to
address unmet need for patients living with cancer.”
About MSS-CRC and ILLUMINATE-206 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. 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.
ILLUMINATE-206 is a Phase 2, open-label, multi-center study to
evaluate tilsotolimod in combination with Opdivo® and Yervoy®* in
immunotherapy-naive micro-satellite stable colorectal cancer
(MSS-CRC) patients. For more information on this trial, please
visit ClinicalTrials.gov.
About HNSCC and the AbbVie CollaborationHead
and neck squamous cell carcinoma (HNSCC) develop in the flat,
scale-like cells that form the lining of the mouth, nose, and
throat. If HNSCC metastasizes to other parts of the body, such as
the lymph nodes or lungs, the cancer has a worse prognosis and can
be fatal. HNSCC is the seventh most common cancer worldwide. Each
year, approximately 50,000 new cases are diagnosed and
approximately 11,000 deaths are attributed to HNSCC in the United
States.
In patients with relapsed or metastatic HNSCC, an overall
survival benefit has been demonstrated for anti-PD-1 immune
therapies versus standard of care chemotherapy. The challenge
remains to increase the percentage of patients responding to these
treatments, which currently ranges from 13% to 23%, depending on
the line of therapy. Given tilsotolimod’s mechanism of action of
activating dendritic cells, it may serve a complementary function
to immune therapies within the tumor microenvironment of HNSCC
patients.
For more information regarding Idera’s collaboration with AbbVie
in HNSCC, see Idera’s September 2019 press release or visit
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 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 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 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,"
"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 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 several 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, 2017 and the Company’s
Quarterly Report filed on Form 10-Q for the period ended September
30, 2018. 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) and Opdivo (nivolumab) 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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