Date of report (Date of earliest event reported):  August 27, 2019


Idera Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)



(State or Other

Jurisdiction of




(Commission File




(I.R.S. Employer

Identification No.)


505 Eagleview Blvd., Suite 212



Exton, Pennsylvania



(Address of Principal Executive Offices)


(Zip Code)


Registrant’s telephone number, including area code: (484) 348-1600


Securities registered pursuant to Section 12(b) of the Act:


Title of each class




Name of each
exchange on which registered

Common Stock, par value $0.001 per share




Nasdaq Capital Market


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


o                  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

o                  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

o                  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240-14d-2(b)).

o                  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c)).


Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).


Emerging growth company o


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  o





Item 1.01                                           Entry into a Material Definitive Agreement.


On August 27, 2019, Idera Pharmaceuticals, Inc. (the “Company”) entered into a clinical trial collaboration and supply agreement (the “Collaboration Agreement”) with AbbVie Inc., a global, research-based biopharmaceutical company (“AbbVie”) to conduct a clinical study to evaluate the efficacy and safety of combinations of an OX40 agonist (ABBV-368), the Company’s TLR-9 agonist, tilsotolimod (IMO-2125), nab-paclitaxel and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181).


Under the terms of the Collaboration Agreement, Idera will provide a clinical trial supply of tilsotolimod to AbbVie and AbbVie will sponsor, fund and conduct the study entitled “A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy Combinations in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma” (the “Study”).  Under the Collaboration Agreement, the Company has agreed to manufacture and supply tilsotolimod at its cost and for no charge to AbbVie for use in the Study.


Unless earlier terminated, the Collaboration Agreement will remain in effect until (a) the completion of the Study and all related obligations with respect to the Study, or (b) the discontinuation of the Study.  The Collaboration Agreement may be terminated, within certain timeframes, by either party (i) in the event of an uncured material breach by the other party, (ii) in the event the other party is insolvent or in bankruptcy proceedings, (iii) in the event any regulatory authority takes any action preventing a Party from supplying its product, or (iv) for safety reasons.  AbbVie may terminate the Collaboration Agreement upon sixty days prior written notice to Idera.


The foregoing description of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration Agreement, which the Company intends to file with the Securities and Exchange Commission as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending September 30, 2019.


Item 7.01                                           Regulation FD Disclosure.


On September 4, 2019, the Company issued a press release regarding the Study.  A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.


The Company is furnishing the information in this Item 7.01 and the related Exhibit 99.1 filed herewith to comply with Regulation FD. Such information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing. This Item 7.01 will not be deemed an admission as to the materiality of any information herein (including Exhibit 99.1) that is required to be disclosed solely by Regulation FD.


Item 9.01.                                        Financial Statements and Exhibits.




Exhibit No.


Exhibit Name



Press Release dated September 4, 2019.






Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.










/s/ Bryant D. Lim



Bryant D. Lim



Senior V.P., General Counsel





Dated: September 4, 2019




Exhibit 99.1



Idera Pharmaceuticals Announces Immuno-Oncology Clinical Research Collaboration with AbbVie


Exton, PA.  September 4, 2019 —Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) announced today that they have entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company.  The purpose of the collaboration is to conduct a clinical study evaluating whether combinations of an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod), chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181) stimulate the immune system resulting in anti-tumor responses.


This Phase 1b, multi-center, open-label study is designed to determine the safety, tolerability, pharmacokinetics and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).


The study will test three separate treatment arms:


·                  ABBV-368 plus tilsotolimod;

·                  ABBV-368 plus tilsotolimod and nab-paclitaxel; and

·                  ABBV-368 plus tilsotolimod, nab-paclitaxel and ABBV-181.


Under the terms of the agreement, Idera will provide clinical trial supply of tilsotolimod to AbbVie and AbbVie will be responsible for conduct of the study.


“We are excited to be entering into this additional clinical collaboration, which continues to advance our strategy of exploring the possibilities to further improve patient outcomes harnessing the immune system against difficult to treat cancers, which historically have not generated significant objective response rates through checkpoint inhibition alone,” stated Elizabeth A. Tarka, M.D., F.A.C.C., Idera’s Chief Medical Officer.  “We look forward to working together with AbbVie to advance our understanding of the combination effect of ABBV-368 and tilsotolimod for these patients.”


About Idera Pharmaceuticals


Harnessing 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.



Idera 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, 2018. While 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.



Robert A. Doody, Jr.

SVP, Investor Relations & Communications

Phone (484) 348-1677