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NewLink Genetics Stock Slides, Company Lays Off 87 After Failed Trial

Written by: | | Dated: Monday, June 27th, 2016

NewLink Genetics Stock Slides and Company Lays Off 87 After Failed Trial
June 27, 2016
By Mark Terry, Breaking News Staff

After announcing that its Phase III clinical trial for algenpantucel-KL for resected pancreatic cancer failed in May, Ames, Iowa-based NewLink Genetics (NLNK) confirmed that it has laid off 87 employees.

On May 9, NewLink indicated that its IMPRESS Phase III study did not achieve its primary endpoint. Overall survival from time of randomization was 29.3 months for both groups, with no statistical difference between the groups. Median survival was 30.4 months and 27.3 months for the control and study groups, respectively, with no statistical different in long-term survival.

“We are deeply disappointed for patients that the IMPRESS Phase III study was not successful, said Nicholas Vahanian, the company’s president and chief medical officer, in a statement at the time. “We want to extend our sincere appreciation to all the patients, caregivers, investigators, research nurses, employees and others who contributed to the study. Given these results, we are evaluating the future of the HyperAcute platform.”

Since that statement, the company ended a contract with the company that would have manufactured algenpantucel-L. It had 2010 employees with offices in Ames, Iowa, Texas and Massachusetts. It also leased space in Ankeny, Iowa for the drug’s production, but no decisions have been made yet regarding that location.

In 2014, NewLink signed a deal with San Francisco’s Genentech (RHHBY) on a different cancer drug, NLG919, an IDO pathway inhibitor, which it plans to continue developing. Under that deal, NewLink received $150 million up front and is eligible to receive more than $1 billion in milestone payments. IDO pathway inhibitors are a class of immune checkpoint inhibitors, similar to others that target CTLA-4, PD-1 and PD-L1.

The company presented data at the 2016 American Society of Hematology Annual Meeting in Chicago in early June on that drug. One presentation poster was on a Phase Ib/II trial of the drug and checkpoint inhibitors in the treatment of unresectable stage 3 or 4 melanoma. The other was the results of a Phase II trial of IDO pathway inhibitor indoximod plus gemcitabine/nab-paclitaxel to treat metastatic pancreas cancer. Both results, which were preliminary, are promising.

NewLink is also working on Ebola virus and Zika virus diseases. At the American Society for Microbiology (ASM) and American Society for Virology (ASV) conference held in early June in Washington, D.C., NewLink’s chief science officer and chief operating officer for the Infectious Disease Division, presented a talk titled “Cognate Pathogenesis of Neurotropic Flaviviruses Relevance to Vaccine Development.”

“NewLink Genetics is committed to developing a vaccine solution to the unfolding human tragedy caused by Zika virus,” Montha said in a statement. “Our R&D group has decades of experience in developing successful vaccines against closely-related flaviviruses, which we are leveraging to accelerate our Zika vaccine program.”

NewLink Genetics stock has been on a downward slide for some time. Shares traded on Sept. 23, 2015 for $52.26, dropped to $32.91 on Oct. 14, 2015, then popped back to $44.93 on Nov. 4. Then shares began a long downward trend to $16.50 on May 9, 2016. They dropped sharply to $9.71 on May 12, and are currently trading for $9.78.

Source: BioSpace

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