- 32.4% of patients evaluable for
efficacy achieved partial response or better; 76.5% of patients
achieved disease control - - Tumor
shrinkage observed in both injected and uninjected lesions,
indicating an abscopal effect -
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today is presenting data
from 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®*).
ILLUMINATE-204 Key Findings:
- 37 patients dosed with 8 mg of tilsotolimod in combination with
ipilimumab were evaluated for this update:
- 34 patients were evaluable for efficacy
- All patients were evaluable for safety
- Accrual is ongoing, with an additional 4 patients dosed
- Responses, including 2 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
- 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
- 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
- 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
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.
“The results from this combination are among the most promising
we have seen in this challenging population of metastatic melanoma
patients who have not benefited from front-line immunotherapy,”
stated Douglas B. Johnson, M.D., Assistant Professor of Medicine,
Clinical Director, Melanoma Research Program, Vanderbilt University
Medical Center. “In addition to the response rate, observing
over 76% of patients achieving disease control is impressive for
such a difficult-to-treat patient population.”
The ILLUMINATE-204 trial is comprised of two distinct patient
populations, patients who are ipilimumab naïve (N=up to 40; Primary
Efficacy Endpoint Population) and patients who have ipilimumab
experience (N=up to 20; Secondary Efficacy Endpoint Population). Of
the initial 34 patients evaluable for efficacy, evaluations 9 of 29
patients from the Primary Efficacy Endpoint Population and 2 of 5
patients from the Secondary Efficacy Endpoint Population achieved
responses.
Indications of the specific mechanism of action for tilsotolimod
were suggested in the clinical responses observed in patients whose
tumor HLA-ABC RNA (MHC class I) expression was low at baseline. As
recently articulated by Rodig, et al.1 robust MHC class I
expression is required for anti-CTLA-4 activity. These findings
suggest that combining tilsotolimod with ipilimumab may overcome
this resistance mechanism and, therefore, enhance the overall
response rate compared to that expected with ipilimumab alone.
“The continued positive results from this trial, a response rate
substantially higher than expected with ipilimumab alone, and
anti-tumor activity in both injected and uninjected lesions are
exciting. These reinforce our conviction that tilsotolimod may
overcome an immunosuppressive tumor microenvironment and, in
combination with ipilimumab, could provide a treatment option when
anti PD-1 therapy fails these patients,” stated Dr. Joanna Horobin,
Idera’s Chief Medical Officer. “These data, along with the
translational data, bolster our confidence in both the Phase 3
trial and taking tilsotolimod beyond melanoma.”
Investor Event and WebcastIdera will host a
conference call and live webcast today, Friday, December 14, at
10:00 A.M. EST to review the data being presented along with
questions and answers. To participate in the conference call,
please dial (844) 882-7837 (domestic) and (574) 990-9824
(international). The webcast can be accessed live or in
archived form in the “Investors” section of the company’s website
at www.iderapharma.com. The company has posted a slide
presentation to the Idera corporate website in the “Investors”
section which will be referenced during the conference call this
morning.
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-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 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 (nivolimumab) are registered
trademarks of Bristol-Myers Squibb.
**Keytruda (pembrolizimab) is a registered trademark of Merck
& Co., Inc.
1 Rodig, S., et al., MHC proteins confer differential
sensitivity to CTLA-4 and PD-1 blockade in untreated metastatic
melanoma. Sci. Transl. Med. 10, eaar3342 (2018).
Idera Pharmaceuticals contact:Robert A. Doody, Jr.VP, Investor
Relations & CommunicationsPhone (484)
484-1677rdoody@iderapharma.com
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