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NewLink updates clinical, financial guidance

May 4, 2017

NewLink Genetics Corporation (NLNK), today reported consolidated financial results for the first quarter 2017, as well as progress in its clinical development programs.

Recent Highlights:

  • Presented promising interim Phase 2 data of the IDO pathway inhibitor, indoximod, in combination with KEYTRUDA® (pembrolizumab) for patients with advanced melanoma at the American Association of Cancer Research (AACR) plenary session on April 4, 2017
  • Presented a poster on NLG802, “A novel prodrug of indoximod with enhanced pharmacokinetic properties,” at AACR on April 4, 2017
  • Abstract accepted for presentation at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) for a randomized double-blind, placebo-controlled Phase 2 study of indoximod in combination with the vaccine, PROVENGE® (sipuleucel-T), for patients with metastatic castration resistant prostate cancer
  • Abstract accepted for presentation at the 2017 ASCO Annual Meeting submitted by our partner on a Phase 1b dose-escalation study of navoximod (GDC-0919) in combination with TECENTRIQ®  (atezolizumab) in multiple solid tumors

“We believe that the emerging clinical data from NewLink Genetics and other companies are validating the fundamental hypothesis that the IDO pathway is central to immuno-suppression in cancer,” said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. “We have two distinct IDO pathway inhibitors advancing in the clinic, indoximod – which is wholly-owned by NewLink Genetics – and navoximod (GDC-0919), which is partnered to Genentech/Roche. In addition, we have a next-generation compound, a novel prodrug of indoximod, NLG802, which we expect to enter the clinic by the end of Q3 this year.”

Guidance for remainder of 2017:

  • Metastatic castration resistant prostate cancer: Randomized, placebo-controlled Phase 2 clinical trial data to be presented at ASCO on Monday, June 5, 2017
  • Metastatic pancreatic cancer: Indoximod in combination with gemcitabine + ABRAXANE®(nab-paclitaxel) Phase 2 trial to be presented at an upcoming medical meeting in the second half of 2017
  • Acute Myeloid Leukemia (AML): Interim data from a Phase 1b dose-escalation study of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed AML to be presented second half of 2017

The Company announced that it intends to initiate a pivotal trial of indoximod plus anti-PD-1 inhibitors for patients with advanced melanoma by the end of 2017.  The trial is expected to use an adaptive design that incorporates a brief dose confirmation stage followed by a definitive randomized stage.

“The clinical data for indoximod in advanced melanoma establishes the basis for this pivotal trial,” said Nicholas N. Vahanian, MD, President and Chief Medical Officer.

Financial Results:

Cash Position: NewLink Genetics ended the first quarter with cash and cash equivalents totaling $118.2 million compared to $131.5 million for the year ending December 31, 2016.

We expect to end 2017 with approximately $75 million in cash and equivalents, which excludes any cash that may be received from financings or milestones.

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