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): April 17, 2017
LION BIOTECHNOLOGIES, INC.
(Exact Name of Registrant as Specified in Charter)
| Nevada | ||
| (State of Incorporation) | ||
| 000-53127 | 75-3254381 | |
| Commission File Number | (I.R.S. Employer Identification No.) | |
| 999 Skyway Road, Suite 150 | ||
| San Carlos, California | 94070 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| (650) 260-7120 | ||
| (Registrant’s Telephone Number, Including Area Code) | ||
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:
| ¨ | 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)). |
| Item 1.01 | Entry Into A Material Definitive Agreement |
On April 17, 2017, Lion Biotechnologies (“we” or “us”) entered into a Strategic Alliance Agreement (the “SAA”) with M.D. Anderson Cancer Center (“M.D. Anderson”) under which we and M.D. Anderson agreed to conduct clinical and preclinical research studies. Initially, we plan to conduct multi-arm clinical trials to evaluate tumor-infiltrating lymphocyte, or TIL, technology in several different cancers using two different TIL manufacturing processes. We and M.D. Anderson will both manufacture TIL for the trials. We and M.D. Anderson also will collaborate in related preclinical research focusing on the expansion of TIL from additional types of tumors in order to identify possible new indications for clinical research.
We have agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA. In return, we will acquire all rights to inventions resulting from the studies and have been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of M.D. Anderson reasonably necessary to exploit, including the commercialization of, any invention. We have also been granted certain rights in clinical data generated by M.D. Anderson outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by us of all deliverables due from M.D. Anderson thereunder.
The foregoing summary of the material terms of the SAA does not purport to be a complete description of the terms and provisions of the SAA. The full text of SAA will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending June 30, 2017, portions of which will be subject to a FOIA confidential treatment request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
| Item 8.01 | Other Events |
On April 19, 2017, we issued a press release announcing the SAA, a copy of which is furnished as Exhibit 99.1 to this Current Report and is incorporated by reference herein.
The information in the accompanying Exhibit 99.1 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
| Item 9.01 | Financial Statements And Exhibits |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of Lion Biotechnologies, Inc., dated April 19, 2017. |
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.
| Date: April 19, 2017 | LION BIOTECHNOLOGIES, INC. | |
| By: | /s/ MARIA FARDIS | |
| Maria Fardis, President and Chief Executive Officer | ||
Exhibit 99.1
Lion Biotechnologies Announces Strategic Alliance with MD Anderson Cancer Center
to Conduct Clinical Trials of TILs in Multiple Solid Tumors
SAN CARLOS, Calif. and HOUSTON – April 19, 2017 -- Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology and The University of Texas MD Anderson Cancer Center, today announced a multi-year strategic alliance agreement involving multi-arm clinical trials to evaluate the safety and efficacy of TIL therapy in ovarian cancer, various sarcomas, and pancreatic cancer. In addition, preclinical research will explore the expansion of TIL in other rare tumor types.
In the clinical trials, TIL therapy will be evaluated in multiple solid tumor cancers using two different TIL manufacturing processes. The trials will be designed by the Lion and MD Anderson joint steering committee and conducted at MD Anderson. A related preclinical research collaboration will focus on the expansion of TIL from additional tumor types to identify new indications for future clinical research. Lion and MD Anderson will both have manufacturing responsibilities for production of TILs used in the planned cellular therapy trials.
“We are excited to form this strategic alliance with MD Anderson. Together, we expect to generate data that will support the pursuit of additional pipeline indications to complement our ongoing Lion-sponsored TIL clinical programs in metastatic melanoma, head and neck and cervical cancers,” said Maria Fardis, PhD, MBA, Lion Biotechnologies’ President and Chief Executive Officer. “This collaboration leverages Lion's strong expertise in TIL therapy and our expanding TIL manufacturing capacity, with MD Anderson's deep experience in developing novel methods for generating TIL and innovative clinical care in treating oncology patients with unmet needs.”
This TIL-based technology is yet another tool in MD Anderson’s ongoing efforts to provide new therapies for our patients,” said Amir Jazaeri, M.D., associate professor of Gyn/Onc and Reproductive Medicine at MD Anderson. “It is our hope that this area of study will further treatment options for multiple types of cancer.”
About Lion Biotechnologies, Inc.
Lion Biotechnologies, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The Company's lead product candidate is an adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) for the treatment of patients with refractory metastatic melanoma. TIL therapy is also being evaluated in clinical trials at the National Cancer Institute, MD Anderson and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer
patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their
families around the world. MD Anderson is one of only 47 comprehensive cancer centers designated by the National Cancer Institute
(NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey.
It has ranked as one of the nation’s top two hospitals since the survey began in 1990, and has ranked first for nine of the
past 10 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
Forward-Looking Statements
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties that are identified by terms such as “will,” “expect” or other words that convey uncertainty of future events or outcomes. Forward-looking statements include those regarding the ability of the Company and/or MD Anderson Cancer Center to complete the clinical trials, expectations regarding the data generated from the strategic alliance, the support the data will provide for other indications in the Company’s ongoing TIL program, the results from the clinical trials, and the other risks described in the Company's filings with the Securities and Exchange Commission, including without limitation in its most recently filed annual report on Form 10-K. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Investor Relations Contact:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah@sternir.com
Media Relations Contact:
Alex Ferrara
inVentivHealth Public Relations
212-849-9487
Alexandra.Ferrara@inventivhealth.com
MD Anderson Media Contact
Ron Gilmore
Rlgilmore1@mdanderson.org
Work: 713-745-1898
Cell: 575-915-5790