Idera Pharmaceuticals Presents ILLUMINATE-101 Data Demonstrating Tilsotolimod Activates Innate and Adaptive Immunity as Monot...
April 02 2019 - 7:00AM
Idera Pharmaceuticals, Inc. (“Idera”) (NASDAQ: IDRA), a
clinical-stage biopharmaceutical company focused on the
development, and ultimately the commercialization, of therapeutic
drugs for both oncology and rare disease indications, today is
reporting clinical and translational data from the ILLUMINATE-101
Phase 1 study which explored the role of investigational
tilsotolimod as monotherapy in patients with various refractory
solid tumors. Data will be presented at the AACR 2019 Annual
Meeting being held in Atlanta, GA.
In the poster presentation entitled, “Activation of Innate and
Adaptive Immunity Using Intratumoral Tilsotolimod (IMO-2125) as
Monotherapy in Patients with Refractory Solid Tumors: a Phase 1b
Study (ILLUMINATE-101)” (abstract number 4062), Hani Babiker, M.D.,
Assistant Professor of Medicine and Associate Director of the Phase
1 Program at the University of Arizona Cancer Center, presented
results from this study.
“Tilsotolimod’s therapeutic mission is to alter the immune
conditions within the tumor microenvironment to help provide more
favorable conditions for checkpoint inhibitors to help achieve
successful outcomes for patients,” stated Dr. Babiker. “We
typically would not expect to see substantial tumor reduction with
tilsotolimod monotherapy; however, it is highly encouraging to see
the number and duration of stable diseases, including some with
tumor reductions, from this study across a wide spectrum of
difficult-to-treat refractory solid tumor types. The finding from
this study bodes well for both the ILLUMINATE-301 Phase 3 trial and
the upcoming ILLUMINATE-206 trial of tilsotolimod in combination
with ipilimumab and nivolumab in multiple planned tumor types,
including those that have not responded favorably to immunotherapy
to date.”
The poster will be presented on Tuesday, April 2, 2019 during
the Biomarkers and Immune Monitoring poster session from 1:00 PM to
5:00 PM at the Georgia World Congress Center, Exhibit Hall B.
In the ILLUMINATE-101 study, patients with histologically or
cytologically confirmed diagnosis of metastatic refractory solid
tumors were enrolled into 4 ascending dose cohorts to receive
tilsotolimod (8mg, 16mg, 23mg and 32mg) injected into a single
lesion. Tumor biopsies of injected and distant lesions were
obtained at baseline and at 24 hours and 6 weeks after commencing
treatment.
ILLUMINATE-101 FINDINGSSafety
Data
- No dose limiting toxicities or treatment-related adverse events
were observed;
- No treatment-emergent adverse events (TEAEs) leading to
treatment or study discontinuation or death occurred; and
- The most common grade 3/4 TEAEs were anemia, hyponatremia,
pain, sepsis (n=3 each), fatigue and thrombocytopenia (n=2
each).
Efficacy Data
- Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease
assessment of stable disease (SD), with a disease control rate of
45%;
- Of the 13 patients with SD, 5 (38%) had maximum tumor shrinkage
>10% below baseline;
- Duration of SD ranged from 1.3 to 9.7+ months from start of
treatment, with 3 patients ongoing; and
- No correlations between dose and efficacy were observed.
Translational Data
- Fresh flow cytometry in 2 of 3 analyzed patients showed HLA-DR
(MHC Class II) upregulation at 24 hours compared with
pre-treatment; and
- Robust activation and upregulation of type I IFN pathway was
observed across analyzed tumor types, demonstrated by increased
IRF7, IFIT1, and IFIT2 gene expression, and early increases in type
I IFN signaling.
“The findings from ILLUMINATE-101 further strengthen the body of
clinical evidence showing that tilsotolimod alters the immune
landscape within the tumor microenvironment, setting the stage for
potentially higher response rates when combined with other
immune-oncology agents,” stated Joanna Horobin, M.B. Ch.B, Idera’s
Senior Vice President, Chief Medical Officer. “This approach
appears to induce upregulation of antigen presentation regardless
of tumor type which increases our confidence as we initiate the
ILLUMINATE-206 trial (NCT03865082) initially focused on treating
patients with squamous cell carcinoma of the head and neck (SCCHN)
and microsatellite stable colorectal cancer (MSS-CRC).”
A copy of the poster presentation is available on Idera’s
corporate website at
http://www.iderapharma.com/our-approach/key-publications/.
About Tilsotolimod (IMO-2125)Tilsotolimod is a
TLR 9 agonist that received Fast Track Designation from the US Food
and Drug Administration (FDA) in 2017 for the treatment of
anti-PD-1 refractory melanoma, in combination with ipilimumab as
well as orphan drug designation from the FDA for the treatment of
melanoma Stages IIb to IV. It signals the immune system to create
and activate cancer-fighting cells (T-cells) to target solid
tumors. Currently approved immuno-oncology treatments,
specifically check-point inhibitors, work for some but not all, as
many patients’ immune response is missing or weak and thus they do
not benefit from checkpoint therapy. Intratumoral injections with
tilsotolimod are designed to selectively enable the tumor-specific
T-cells to recognize and attack cancers that remained elusive and
unrecognized by the immune system exposed to checkpoint inhibitors
alone, while limiting toxicity or impact on healthy cells in the
body. 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.
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, future operations,
collaborations, 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,
including 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 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; whether
products based on the company’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 set forth under the
caption “Risk Factors” in the company’s Annual Report on Form 10-K
for the year ended December 31, 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.
Investor and Media ContactRobert DoodySr. Vice
President, Investor Relations and Corporate CommunicationsOffice:
484-348-1677rdoody@iderapharma.com
Idera Pharmaceuticals (NASDAQ:IDRA)
Historical Stock Chart
From May 2024 to Jun 2024
Idera Pharmaceuticals (NASDAQ:IDRA)
Historical Stock Chart
From Jun 2023 to Jun 2024