- Results from the Phase 2 Expansion of
ILLUMINATE-204 anticipated to be reported in the 4th Quarter of
2019 –
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced
completion of enrollment into the ongoing phase 2 expansion of the
ILLUMINATE-204 trial investigating tilsotolimod, Idera’s
intratumorally-delivered toll-like receptor 9 (TLR9) agonist, in
combination with ipilimumab (Yervoy®*) in patients with
unresectable or metastatic melanoma following failure of PD-1
inhibitor treatment.
52 patients have been dosed in the trial which included two
separate patient groups. The company completed the targeted
enrollment of 40 patients in the primary enrollment population,
constituting patients who are naïve to prior ipilimumab treatment
in the metastatic setting. This patient population mirrors
the enrollment for the ILLUMINATE-301 phase 3 pivotal trial.
The secondary exploratory enrollment population targeted up to 20
patients who had prior ipilimumab treatment in the metastatic
setting.
The ILLUMINATE-204 trial is a multi-center trial being conducted
at 10 sites throughout the United States.
The company is currently enrolling ILLUMINATE-301, a global,
multi-center, randomized Phase 3 trial that compares effectiveness
and safety between two treatment groups: tilsotolimod combined with
ipilimumab versus ipilimumab given alone. This trial is being
conducted at up to 100 centers with a target enrollment of 308
patients. Enrollment remains on track and is expected to be
completed in the 4th quarter of 2019.
The company also recently received notice from the U.S. Food and
Drug Administration that the company can proceed to implement the
ILLUMINATE-206 clinical trial under a new Investigational New Drug
(IND) Application. The ILLUMINATE-206 trial will test the
safety and effectiveness of tilsotolimod in combination with
ipilimumab and nivolumab in treating patients with Squamous Cell
Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable
Colorectal Cancer (MSS-CRC). The ILLUMINATE-206 trial is
expected to initiate in the second quarter of 2019.
“We made tremendous progress with the clinical development of
tilsotolimod in the second half of 2018, and enrollment in the
phase 3 study in patients with melanoma progressing on PD-1 therapy
is tracking to complete by the end of 2019.” stated Joanna Horobin,
M.B. Ch.B, Idera’s Chief Medical Officer. “Oncologists are
enthusiastic to extend the use of tilsotolimod to potentially
improve the outcome of immuno-therapy for other patient
populations, such as head and neck cancer, and in microsatellite
stable CRC where so far immunotherapy outcomes have not been
optimal.”
As a reminder, the company provided an interim data update from
the ILLUMINATE-204 trial in December 2018.
Summary of ILLUMINATE-204 Key Findings from the December
2018 Update:
- 37 patients dosed with 8 mg of tilsotolimod in combination with
ipilimumab were evaluated for the December 2018 update;
- All 37 patients were evaluable for safety;
- The combination regimen continues to be generally well
tolerated. 9/37 subjects (24.3%) had immune-related toxicities
indicating that tilsotolimod + ipilimumab does not appear to add
immune-related toxicity versus ipilimumab alone;
- Injection-related toxicities were grade 1-2 transient fever and
flu-like symptoms lasting <48 hours;
- 34 patients were evaluable for efficacy;
- Responses, including 3 Complete Responses (CR), were observed
in 11 of the 34 evaluable patients (32.4%);
- Duration of response ranges from > 1 month to > 30
months, with 36% of responses ongoing at the time of the
report;
- Per RECIST v1.1, the Overall Response Rate (ORR) is 29.4%; one
patient with an unconfirmed Partial Response (uPR) at the end of
treatment assessment progressed due to a new lesion at the 3-month
follow-up disease assessment;
- Overall, 26 patients out of 34 evaluable for efficacy (76.5%)
experienced disease control (CR, PR, or Stable Disease [SD]);
- Analysis of spider plots show tumor shrinkage in both injected
and uninjected lesions, indicating an abscopal effect;
- Responding subjects include one patient with mucosal melanoma
and one patient with acral melanoma, two forms of melanoma that are
particularly difficult to treat; and
- Importantly, 2 of 5 patients with prior ipilimumab experience
achieved responses, further demonstrating a signal that
tilsotolimod has the potential to help overcome prior ipilimumab
resistance.
Additionally:
- A RECIST v1.1 PR of > 2.5 years is ongoing in 1 patient
treated with tilsotolimod 4 mg in combination with ipilimumab;
and
- A RECIST v1.1 CR of > 1 year is ongoing in 1 patient treated
with tilsotolimod 16 mg in combination with pembrolizumab.
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 the 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 ILLUMINATE-301The ILLUMINATE-301 study
(2125-MEL-301) is for patients who have metastatic melanoma for
whom treatment with an anti-PD-1 drug like Keytruda®
(pembrolizumab) or Opdivo® (nivolumab) has failed.
ILLUMINATE-301 is a global, multi-center, randomized Phase 3 study
that compares the effectiveness and safety between two treatment
groups: IMO-2125 combined with ipilimumab (Yervoy®) versus
ipilimumab given alone.
For additional details about ILLUMINATE-301, please go to
clinicaltrials.gov and search for study identifier NCT03445533.
About ILLUMINATE-204The ILLUMINATE-204 study
(2125-204) is for patients who have metastatic melanoma for whom
treatment with an anti-PD-1 drug like Keytruda®** (pembrolizumab)
or Opdivo®* (nivolumab) has failed. ILLUMINATE-204 is a
multi-center, two-arm Phase 1/2 study that tests the safety and
effectiveness of tilsotolimod in combination with either ipilimumab
(Yervoy®) or pembrolizumab (Keytruda®) for the treatment of
patients with anti-PD-1 refractory metastatic melanoma.
For additional details about ILLUMINATE-204, please go to
clinicaltrials.gov and search for study identifier NCT02644967.
About ILLUMINATE-206The ILLUMINATE-206 study
(2125-206) is a Phase 2 multi-center, multi-cohort study of
intratumoral tilsotolimod in combination with nivolumab and
ipilimumab in patients with Squamous Cell Carcinoma of the Head and
Neck (SCCHN) who are either immunotherapy naïve and immunotherapy
refractory and immunotherapy naïve patients with Microsatellite
Stable Colorectal Cancer (MSS-CRC). The trial is expected to
open for enrollment in the second quarter of 2019.
About Metastatic MelanomaAlthough melanoma is a
rare form of skin cancer, it comprises over 75% of skin cancer
deaths. The American Cancer Society estimates that there were
approximately 76,000 new invasive melanoma cases and 10,000 deaths
from the disease in the USA in 2016. Additionally, according
to the World Health Organization, about 132,000 new cases of
melanoma are diagnosed around the world every year.
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 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 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, 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.
**Keytruda (pembrolizimab) is a registered trademark of Merck
& Co., Inc.
Idera Pharmaceuticals contact:Robert A. Doody, Jr.VP, Investor
Relations & CommunicationsPhone (484)
484-1677rdoody@iderapharma.com
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