UPDATED: NewLink wins $26.1M in government funding to advance Ebola vaccine
In the third and fourth government grants toward Ebola vaccines in two weeks, NewLink Genetics ($NLNK) won a total of $26.1 million in funding from the DOD's Defense Threat Reduction Agency and HHS' BARDA in the span of just over a week.
The DOD's base contract has future options totaling $5.2 million to further the development of NewLink's rVSV-ZEBOV candidate, the company reported in a statement late last week. BARDA's funding builds on an initial $30 million contract awarded to the company in late 2014.
NewLink has licensed the research, development and manufacturing of the vaccine--which posted 100% efficacy in interim results from a novel ring study this summer--to Merck ($MRK).
"This additional funding by BARDA will help NewLink and Merck accelerate large-scale production of this Ebola vaccine candidate and demonstrates government commitment to this important project," Dr. Charles Link, NewLink CEO and CSO, said in a statement. "In collaboration with Merck, we will continue to work diligently to bring this vaccine candidate to patients in need as quickly as possible."
As the Ebola outbreak in West Africa waned, Merck and NewLink struggled to recruit for late-stage clinical trials. Merck and competitor GlaxoSmithKline ($GSK) had to stop enrolling for Phase III trials in Liberia at 1,500 patients, far short of the 27,000 that they had envisioned.
The lack of volunteers that would be exposed to enough Ebola disease for a traditional trial led researchers to conduct a ring study instead. The team identified more than 7,000 people in Guinea at risk of Ebola infection. Half received the vaccine immediately after exposure to Ebola and the other half received it after a delay.
The study is ongoing. While the interim data reported in August is encouraging, the study is not a traditional randomized, placebo-controlled trial, the scientific gold standard. The FDA's Vaccines and Related Biological Products Advisory Committee met in May to discuss alternative pathways to approval for an Ebola vaccine, including accelerated approval and postlicensure placebo-controlled studies.
GlaxoSmithKline is working on its candidate as a single jab as well as with a booster from Emergent BioSolutions ($EBS). Johnson & Johnson ($JNJ) struck a $28.5 million partnership with BARDA this month to further develop the prime-boost regimen on which it is collaborating with Bavarian Nordic. And just last week, a team led by Inovio Pharma ($INO) scored $24 million from DARPA to develop Ebola treatments and vaccines.
- read the DOD grant release
- here's the BARDA award statement
Inovio-led team picks up $24M from DARPA to develop Ebola vaccine, treatments
J&J's Janssen strikes four-year, $28.5M government partnership to advance Ebola vaccine
Merck Ebola vaccine posts 100% efficacy in PhIII
Ebola vaccines left hanging as GSK, Merck, J&J scramble for trial volunteers