Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a pharmaceutical company
focused on the development and commercialization of its proprietary
immune modulator, tilsotolimod, for the treatment of cancer, is
providing an update on the company’s corporate strategy and outlook
following the recent termination of its proposed merger with
BioCryst Pharmaceuticals.
Vincent Milano, Idera’s Chief Executive Officer stated, “Today,
we advance the next chapter of our company’s future with a clear
picture of our mission, which is to ultimately deliver tilsotolimod
to as many patients suffering from cancer as we possibly can. We
have generated a significant body of evidence
for tilsotolimod, including pre-clinical
studies, translational research and meaningful clinical
data in our ongoing ILLUMINATE-204 trial in anti-PD-1
refractory melanoma, as well as Fast Track Designation from the
Food and Drug Administration. This gives us a great deal of
confidence in tilsotolimod’s ability to prime the immune system to
play a more powerful role in the fight against cancer, representing
an exciting value proposition for both shareholders and
patients.”
Milano continued, “We are executing on the pivotal Phase 3
trial, ILLUMINATE-301, in anti-PD-1 refractory melanoma and are
partnering with three separate planned investigators/institutions
in support of their respective investigator sponsored
trials (ISTs), each of which is exploring tilsotolimod in
different patient populations. Through the body of data we’ve
generated to date, as well as from our discussions with our key
opinion leader advisors, it has become abundantly clear to us that
tilsotolimod has the opportunity to play a more expanded role in
the immuno-oncology landscape, particularly in tumor types with
limited immunogenicity that have not previously responded well to
check-point inhibition approaches.”
Financial Outlook and Other Corporate
Updates
Idera ended the 1st Quarter of 2018, with cash and cash
equivalents totaling $107.5 million, which as of the reporting of
the first quarter of 2018 is anticipated to fund current operations
into the third quarter of 2019. Subsequently, Idera announced
an agreement with Bristol-Myers Squibb related to the funding of
ipilimumab for the ILLUMINATE-301 trial, the cost of which we had
previously budgeted for in our cash forecast, and as a result of
the terminated merger with BioCryst Pharmaceuticals we also
received $6 million in related fees. These two items have not
yet been reflected in the Company’s financial runway and will be
updated as the results of the 2nd quarter of 2018 are reported.
In addition, as previously disclosed on June 20, 2018,
shareholders voted to approve giving the Board of Directors
discretion to implement a reverse stock split of not less than
1-for-4 and not more than 1-for-8.
Idera has Significant Near-term Milestones Representing
Substantial Value Creation Opportunities:
• Continued updates on ILLUMINATE-204 Phase 2 trial of
tilsotolimod in combination with ipilimumab in patients with PD-1
refractory melanoma at upcoming medical conferences;
- Recently increased trial sites open to enrollment to 7, (3
additional planned);
- Expected completion of enrollment (N=60 patients) by year end
2018;
• Data update following completion of ILLUMINATE-204
Pembrolizumab combination Phase 1 component of the trial;
• Data from ILLUMINATE-101 tilsotolimod monotherapy trial;
• Complete enrollment in ILLUMINATE-204 with topline data in
mid-2019;
• Initiation of Investigator Sponsored Trials (IST):
- A Phase 1/2 open label study of intratumoral tilsotolimod in
combination with intratumoral ipilimumab and IV nivolumab in a
protocol open to multiple tumor types including non-small cell lung
cancer (NSCLC), melanoma, squamous cell carcinoma of the head and
neck and urothelial carcinoma. The principal investigator
initiating this trial is Aurélien Marabelle, MD, PhD, Clinical
Director of the Cancer Immunotherapy Program at Institut Gustave
Roussy, Villejuif, France.
- A Phase 2 study of intratumoral tilsotolimod in combination
with IV pembrolizumab in patients with NSCLC. The principal
investigator initiating this trial is Arafat Tfayli, MD, Professor
of Clinical Medicine, Director of Hematology/Oncology Fellowship
Program at the American University of Beirut Medical Center
(AUBMC), Lebanon.
- A Phase 2 placebo controlled study of intradermal
administration of tilsotolimod in patients with T3/T4 primary
melanoma scheduled to undergo a combined re-excision and sentinel
node biopsy (SNB) procedure. The principal investigators initiating
this are Bas Koster, MD and Tanja de Gruijl, PhD at The VU
University Medical Center, Amsterdam, the Netherlands, and
• Potential collaborations and or partnerships with
immuno-oncology companies to further demonstrate the utility of
tilsotolimod in treating solid tumors.
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 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.
Out of the 30 patients treated and evaluated across all four
dosing cohorts from the beginning of the Phase 1 portion of the
study through our presentation at ASCO 2018, in the ILLUMINATE-204
Phase 1/2 Ipilimumab combination arm, 9 patients have RECIST v1.1
responses (PR or CR) representing a 30% Overall Response Rate
(ORR). Based on the combination of clinical responses and
supportive translational evidence, the 8mg dose of tilsotolimod was
selected for clinical development advancement in the anti-PD-1
refractory melanoma indication.
Key findings from the most recent data presented at ASCO
in June 2018 related to the ILLUMINATE-204 Phase 2 trial assessing
the combination of the 8mg dose of tilsotolimod in combination with
ipilimumab in anti-PD-1 refractory metastatic melanoma
included:
- 21 patients treated with the 8mg dose of tilsotolimod in
combination with ipilimumab have had disease evaluations (as of May
9, 2018 data cut);
- RECIST v1.1 responses (including 2 Complete Response [CR]) were
observed in 8 of these 21 patients (38.1%);
- Six of 8 responses are ongoing (1 CR ongoing for nearly 2
years); median duration of response has not yet been reached;
- Overall 15 out of these 21 patients (71.4%) experienced disease
control (CR, PR, or SD);
- The combination regimen is generally well tolerated. 6 of 26
patients (23%) had immune-related toxicities indicating that
tilsotolimod + ipilimumab does not appear to add toxicity versus
treatment with ipilimumab alone.
- Injection-related toxicities were grade 1-2 transient fever and
flu-like symptoms lasting <48 hours; and,
- 15 of 26 patients (57.7%) with lesions accessible only by
image-guided injection (5 deep visceral lesions and 10 lymph nodes)
were included.
About Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and Idera’s
experience in developing proprietary immunology technologies,
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 is committed to working with investigators and partners who
share the common goal of addressing the unmet needs of patients
suffering from difficult to treat, unmet cancers. 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 March 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 DoodyVice
President, Investor Relations and Corporate CommunicationsOffice:
617-679-5515Mobile: 484‐639‐7235rdoody@iderapharma.com
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