NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain OfficersItem 5.02.Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On April 11, 2018, Paul Edick notified NewLink Genetics Corporation ("NewLink") that he will resign his position as a member of the board of directors of NewLink effective April 30, 2018. Mr. Edick's professional obligations have increased, and he has determined that it will not be feasible for him to continue as a member of the NewLink board. Mr. Edick served as a director of NewLink since July 2011. His resignation is not due to any disagreement with NewLink regarding any of its operations, policies or practices.
NewLink has identified a candidate for director to fill the vacancy created by Mr. Edick’s resignation.
Section8 – Other Events
Item 8.01.Other Events.
On April 15, 2018, NewLink issued a press release titled "NewLink Genetics Announces Initial Phase 1 Data with Indoximod Plus Radiation and Chemotherapy for Pediatric Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Presented During AACR Plenary."
The Company has determined that it will not initiate the randomization portion of Indigo301, its study of indoximod in combination with pembrolizumab or nivolumab for patients with advanced melanoma. NewLink’s clinical team will evaluate the design, trial size and feasibility of an alternative randomized evaluation of indoximod in melanoma in the context of the failure of a competitor’s trial of its enzymatic IDO inhibitor in a similar clinical setting. Our evaluation will include analysis of the full data set from the Company’s single-arm Phase 2 melanoma study, the differentiated mechanism of action of indoximod, and the opinions of experts in the field. The company plans to present final results from its Phase 2 melanoma trial and its single-arm Phase 2 pancreatic cancer trial at an upcoming medical meeting in the first half of this year.
Indoximod had demonstrated encouraging clinical data in other cancer indications in combination with chemotherapy, vaccines, radiotherapy, and checkpoint blockade. The company is currently evaluating the most promising indications within the indoximod program to move further into Phase 2 development.
A copy of the press release and the accompanying presentation slides are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.
Section9 – Financial Statements and Exhibits
Item 9.01.FinancialStatements and Exhibits.
(d) Exhibits.
NEWLINK GENETICS CORP ExhibitEX-99.1 2 nlnk-20180416x8kxex991.htm PRESS RELEASE Exhibit Exhibit 99.1NewLink Genetics Announces Initial Phase 1 Data with Indoximod Plus Radiation and Chemotherapy for Pediatric Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Presented During AACR PlenaryEarly data indicate indoximod has clinical activity when used in combination therapies beyond PD-1 inhibitionAMES,…To view the full exhibit click here
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.
