NewLink Genetics ($NLNK) saw its shares plunge after it announced that a Phase III trial for its pancreatic cancer vaccine flopped--with patients using standard therapy actually living longer than those on NewLink’s treatment.
The Ames, IA-based biotech released its now ironically named “Impress” Phase III study of algenpantucel-L in more than 700 patients with resected pancreatic cancer.
The therapeutic cancer vaccine did not achieve its primary endpoint, with median survival being 30.4 months for the control groups and 27.3 months for study groups--meaning that those not using its experimental vax lived around three months longer than those who didn’t.
NewLink said that there was no statistical difference for long-term survival and looked to a three-year survival stat, which showed 41.4% and 42.1%, and said four-year survival was 32.6% and 32.7% for the control and study groups, respectively.
This has not passed muster with many, however, with TheStreet columnist Adam Feuerstein saying: “NewLink deserves to be investigated for this disastrous pancreatic trial result. A 3-month OS difference in wrong direction is outrageous.”
And investors will now likely assign a zero value to the company's HyperAcute platform--which includes algenpantucel-L and other experimental meds for other cancers--Cantor Fitzgerald's Mara Goldstein told Reuters.
"We are deeply disappointed for patients that the Impress Phase III study was not successful," said Nicholas Vahanian, president and CMO of NewLink Genetics.
“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. We remain committed to achieving our mission of developing immunotherapies to bring patients with cancer better treatment options.”
The company will now likely need to lean more heavily on its batch of IDO inhibitor immunotherapies should it have to ditch its HyperAcute platform. This follows on from a slew of late-stage cancer vax failures over the past 5 years as many pharmas and biotechs have struggled to bring an effective, safe therapeutic oncology vaccine to market.
Pancreatic cancer is one of the most difficult cancers to treat with a very high mortality rate. Around 53,000 Americans will be diagnosed with pancreatic cancer in 2016--of which some 41,780 will succumb to the disease, according to the American Cancer Society.
The biotech was down 34% in after-hours trading.
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