UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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): August 23, 2018
bluebird bio, Inc.
(Exact name of Registrant as Specified in Its Charter)
|
DELAWARE |
001-35966 |
13-3680878 |
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
|
60 Binney Street, Cambridge, MA |
|
02142 |
|
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (339) 499-9300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 Instructions A.2. below):
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
☐ |
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 ☐
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. ☐
|
Item 8.01 |
Other Events. |
On August 23, 2018, bluebird bio, Inc. (“bluebird”) issued a press release announcing that bluebird has entered into a research collaboration and license agreement with Gritstone Oncology, Inc. focusing on the development and commercialization of products for the treatment of cancer using cell therapy.
The full text of the press release regarding the announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
|
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
|
|
|
|
|
Exhibit No. |
|
Description |
|
99.1 |
|
Press release issued by bluebird bio, Inc. on August 23, 2018. |
|
|
|
|
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.
|
|
|
|
|
|
|
Date: August 23, 2018 |
bluebird bio, Inc.
|
|
||
|
|
By: |
/s/ Jason F. Cole |
|
|
|
|
|
Jason F. Cole |
|
|
|
|
|
Chief Legal Officer |
|
|
Exhibit 99.1
bluebird bio and Gritstone Oncology Announce Strategic Collaboration to Develop Novel Cancer Cell Therapies
CAMBRIDGE, MASS. and EMERYVILLE, CALIF. – Aug. 23, 2018 – bluebird bio, Inc. (Nasdaq: BLUE) and Gritstone Oncology, Inc. today announced a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy. Gritstone Oncology will leverage its proprietary EDGE™ artificial intelligence platform to analyze specific tumor types to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in bluebird bio’s established cell therapy platforms. bluebird bio will conduct all development, manufacturing and commercial activities. Gritstone Oncology will utilize its proprietary technology platform to enable patient selection for clinical development of such therapies.
“By combining our expertise in gene and cell therapy with Gritstone Oncology’s unique target identification and TCR technology, we hope to bring the power of cell therapy to a broader set of newly-validated targets, enabling us to treat previously unaddressable patient populations,” said Philip Gregory, D.Phil., chief scientific officer of bluebird bio. “As we expand our immuno-oncology focus and portfolio, this collaboration with Gritstone Oncology is highly complementary to our goal of rapidly advancing novel cellular therapies with the potential to transform the lives of people with cancer, particularly in solid tumor indications.”
“As the field of immuno-oncology has evolved, it has become clear that targeting T-cell therapeutics to solid tumors in a highly specific manner is vital to enable potent tumor cell killing with sparing of normal tissues,” said Andrew Allen, M.D., Ph.D., president and chief executive officer of Gritstone Oncology. “We believe that our artificial intelligence-based approach to identifying tumor-specific targets and corresponding, naturally occurring TCRs, combined with bluebird bio’s expertise in gene and cell therapy, will allow us to develop cellular immunotherapies against differentiated oncology targets. We look forward to collaborating with the bluebird bio team in order to develop innovative treatments for patients in need.”
Under the terms of the agreement, Gritstone Oncology will provide 10 tumor-specific targets across several tumor types and, in certain cases, TCRs directed to those targets to bluebird bio. Gritstone Oncology will receive $20 million in an upfront payment and an additional $10 million in the form of a Series C preferred equity investment. In addition, Gritstone Oncology is eligible for significant development, regulatory and commercial milestones on any therapies, and tiered royalties on certain approved therapies.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built a pipeline with broad potential application in severe genetic diseases and cancer.
bluebird bio's gene therapy clinical programs include investigational treatments for cerebral adrenoleukodystrophy, transfusion-dependent β-thalassemia, also known as β-thalassemia major, and severe sickle cell disease.
bluebird bio's oncology pipeline is built upon the company's lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. The company’s lead oncology programs are anti-BCMA CAR T programs partnered with Celgene.
bluebird bio’s discovery research programs include utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company's pipeline.
bluebird bio has operations in Cambridge, Massachusetts; Seattle, Washington; Durham, North Carolina and Zug, Switzerland.
About Gritstone Oncology, Inc.
Gritstone Oncology is developing tumor-specific cancer immunotherapies to fight multiple cancer types. The company has built its approach on two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which provides the powerful ability to predict from a routine tumor biopsy the tumor-specific neoantigens, or TSNA, that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to drive the patient’s immune system to attack and destroy tumors. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing from Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, Redmile Group, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments and Bay City Capital. More information can be found at www.gritstone.com or @gritstoneonc.
bluebird bio Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the research, development and advancement of bluebird bio’s product candidates and immuno-oncology research program, including its TCR research program and those shared with Gritstone Oncology, the amounts of milestone and royalties potentially payable to Gritstone Oncology, and the benefits of each company’s strategic plans and focus. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the research programs for these targets will be unsuccessful and not
identify any viable product candidates, the risk that our collaboration with Gritstone Oncology will not continue or will not be successful, the risk of cessation or delay of any planned clinical studies and/or our development of our product candidates, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.
Gritstone Oncology Contacts
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
or
Alexandra Santos
Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com
bluebird bio Contacts
Investor Relations
Elizabeth Pingpank, 617-914-8736
epingpank@bluebirdbio.com
or
Media Relations
Stephanie Fagan, 201-572-9581
sfagan@bluebirdbio.com