UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported):  March 11, 2019

 

Idera Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

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

 

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.

 

Effective March 11, 2019, Idera Pharmaceuticals, Inc. (the “Company”) entered into a clinical trial collaboration and supply agreement (the “Collaboration and Supply Agreement”) with Bristol-Myers Squibb Company (“BMS”) to clinically evaluate the combination of the Company’s TLR-9 agonist, tilsotolimod (IMO-2125), with BMS’s therapy YERVOY® (ipilimumab) and OPDIVO® (nivolumab).

 

Under the Collaboration and Supply Agreement, the Company will sponsor, fund and conduct the Company’s Phase 2, open-label, global, multi-center, multi-cohort study of intratumoral tilsotolimod in combination with YERVOY® and OPDIVO® entitled “Study of Tilsotolimod in Combination with Nivolumab and Ipilimumab For the Treatment of Solid Tumors” in accordance with an agreed-upon protocol (the “Trial”).  The Company refers to the Trial as ILLUMINATE-206.  Under the Collaboration and Supply Agreement, BMS has granted to the Company a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use YERVOY® and OPDIVO® in the Trial and has agreed to manufacture and supply YERVOY® and OPDIVO®, at its cost and for no charge to the Company, for use in the Trial.

 

Unless earlier terminated, the Collaboration and Supply Agreement will remain in effect until (a) the completion of the Trial, (b) all related Trial data has been delivered to both parties and (c) the completion of any statistical analyses and bioanalyses contemplated by the Trial protocol or any analysis otherwise agreed upon by the parties.  The Collaboration and Supply Agreement may be terminated 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 or (iii) for safety reasons.  Upon termination, the licenses granted to the Company to use YERVOY® and OPDIVO® in the Trial will terminate.

 

The foregoing description of the Collaboration and Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration and Supply 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 March 31, 2019.

 

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SIGNATURES

 

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.

 

	IDERA PHARMACEUTICALS, INC.
	By:	/s/ Bryant D. Lim
		Bryant D. Lim
		Senior V.P., General Counsel

 

Dated: March 13, 2019

 

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