NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Other Events
Item 8.01. Other Events.
corporation, or the Company, issued a press release titled
“NewLink Genetics to Regain Rights to GDC-0919.”
are attached hereto as Exhibit 99.1 and 99.2, respectively, and
are incorporated herein by reference.
October 14, 2014 with Genentech, a member of the Roche Group, or
the Genentech Agreement, the termination of Genentechs rights to
GDC-0919 will become effective 180 days after the Company
receives formal notice from Genentech. Upon such termination,
Genentech will grant to the Company an exclusive, worldwide,
royalty-bearing, sublicensable license, under certain Genentech
intellectual property, to research, develop, manufacture and
commercialize GDC-0919, and the Company will be required to pay a
low single-digit royalty to Genentech on any sales of GDC-0919,
should the Company proceed to develop and commercialize that
compound. Genentech is obligated to transfer the Investigational
New Drug Application for GDC-0919 to the Company and to assign to
the Company all data arising from the studies that Genentech
conducted on GDC-0919. The Company has the right to purchase
Genentechs existing inventory of GDC-0919 at cost. At the
Companys request, Genentech is obligated to supply the Company
with GDC-0919 for one year after termination and to facilitate
the Companys efforts to obtain an alternative source of supply
for GDC-0919. Genentech will be responsible for all costs of
winding down the clinical trials for GDC-0919 that Genentech was
conducting at the time of termination.
Exhibit Number
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Description
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99.1
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Press Release, dated June 8, 2017, entitled NewLink
Genetics to Regain Rights to GDC-0919 |
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99.2
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GDC-0919 Update Slide Deck
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About NewLink Genetics Corporation (NASDAQ:NLNK)
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing immunotherapeutic products for cancer treatment. The Company’s portfolio includes biologic and small-molecule immunotherapy product candidates for a range of oncology indications. Its biologic product candidates are based on its HyperAcute immunotherapy technology platform, which is designed to stimulate the human immune system. Algenpantucel-L is its clinically advanced product candidate for patients with pancreatic cancer. Its additional HyperAcute cellular HyperAcute Cellular Immunotherapy product candidates in clinical development include tergenpumatucel-L and dorgenmeltucel-L for patients with advanced lung cancer and melanoma. It has two small-molecule product candidates in clinical development: GDC-0919 and indoximod. These product candidates are indoleamine-2, 3-dioxygenase (IDO) pathway inhibitors and focus on breaking the immune system’s tolerance to cancer.