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NewLink Genetics: Ready to test Ebola vaccine

By WTOP Staff

TOM MURPHY
AP Business Writer

An Iowa drug developer is preparing to test a possible Ebola vaccine in humans, as scientists race to develop ways to prevent or fight a virus that has killed more than 1,000 people in a West African outbreak.

NewLink Genetics is planning an initial phase of testing involving up to 100 healthy volunteers and is talking with regulators about the study, said Brian Wiley, the company’s vice president for business development. He declined to say whether the drug developer has submitted an application for the research to the Food and Drug Administration.

Chief Financial Officer Gordon Link said Thursday the timing of the testing, which would involve up to 100 healthy volunteers, is uncertain.

“We’re getting a lot of assistance from a number of sources to accelerate this, so exactly how long it’s going to take is a little uncertain because people are greasing the paths as much as they can,” he said.

There is no proven treatment or vaccine for Ebola, and the current outbreak, which also has sickened nearly 2,000 people, is the largest in history. The outbreak was first detected in March in Guinea and spread to Liberia, Sierra Leone and Nigeria.

Other possible Ebola vaccines under development include one developed at the National Institutes of Health that is set to begin early-stage testing in humans this fall.

On Wednesday, Canadian drugmaker Tekmira Pharmaceuticals Corp. said it wasn’t ready to make its experimental Ebola drug available in Africa.

NewLink Genetics Corp. is planning to test a vaccine that was discovered by scientists working for the Canadian government. The U.S. drugmaker has an exclusive license to take it through clinical trials and then sell it if regulators grant approval.

NewLink said the vaccine has been 100 percent effective in preventing deadly Ebola infections in non-human primates, and it acts quickly enough to show effectiveness in animals that received a typically lethal dose of the virus.

The vaccine contains an antigen from the Ebola virus, and it essentially teaches a person’s immune system how to fight the virus.

“This is a very traditional vaccination process,” said Dr. Nicholas Vahanian, NewLink’s chief medical officer.

Researchers will be focused mainly on the vaccine’s safety in the initial round of testing, but they also will measure the antibodies the subject’s body produces to fight the virus.

“By measuring their immune response to the vaccine, you can predict the effectiveness,” Vahanian said.

The company also is working to line up manufacturing partners to make additional doses of the vaccine.

“It is not a particularly challenging vaccine to manufacture,” Vahanian said. “We are expending all our efforts to be able to secure additional manufacturing partners so we can meet high demand.”

A total of 1,500 doses have already been produced by a contract manufacturer in Germany, and the Canadian government purchased all of them. The government is setting aside some for NewLink to use in clinical research, and it also plans to donate between 800 and 1,000 doses to the World Health Organization, which is coordinating the international response to the latest outbreak.

Earlier this month, NewLink, which has no products on the market, announced a $1 million contract with the U.S. Defense Threat Reduction Agency to help fund research leading up to the human testing.

Shares of the Ames, Iowa, company soared almost 12 percent, or $2.73, to $26.17 in trading Thursday, while broader indexes rose less than 1 percent.

___

AP Medical Writer Lauran Neergaard contributed to this report from Washington.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Don’t Settle for Student Loans to Pay for Online Education

By WTOP Staff
Online college programs are becoming a more popular choice for prospective students, with one study finding that more than 6 million students enrolled in at least one online course in fall 2015. The popularity of these courses can be attributed in part to their flexibility with working adults' schedules, students' ability to progress more quickly through online programs and, oftentimes, cheaper tuition. [See 10 low-cost online bachelor's programs for out-of-state students.]Online degrees can be beneficial to many college students, but some studies have shown online learners complete their programs at lower rates than students at traditional brick-and-mortar campuses. Individuals with student loans but no degree comprise two-thirds of defaulted borrowers. Though these numbers are not encouraging, just like for traditional programs, there are ways to reduce how much you'll need to borrow for an online program to ensure you won't become one of these statistics. Don't just settle on borrowing student loans to cover the whole cost of your program and living expenses. Instead, start thinking about how to cut costs and cover your balance in different ways, such as the following. -- Grants and scholarships: Even though you are taking an online course, you can still apply and receive grants and scholarships. But your first step should be to complete the Free Application for Federal Student Aid, commonly referred to as the FAFSA, which will allow you to receive a Pell Grant if your expected family contribution is low enough. The EFC criteria and award amounts are adjusted annually, but the 2017-2018 academic year awards range from $606 to $5,920, which could significantly lower the amount you borrow annually. Your next step is to apply for scholarships. You can start by checking online scholarship search engines, such as the Salt Scholarship Search, College Board's BigFuture and Peterson's. But don't forget to take advantage of local organizations and your school's financial aid office. Both may offer scholarships that you can't find with a national scholarship search. [Review these 10 sites to kick off your scholarship search.]For instance, organizations like the Elks Club, Knights of Columbus or the Rotary Club typically offer scholarships annually to local students. Just because you're going to school online doesn't mean you're ineligible. Visit your local library for scholarship listings, and ask around town. You might be surprised how many local organizations offer scholarships. While these scholarships typically aren't large, every little bit counts. Each dollar you receive in a scholarship is a dollar you don't have to borrow and pay interest on. -- Work-study: Another option for online students may be work-study awards. Not all students enrolled in online programs are eligible, but students at some schools -- including, for example, SUNY Empire State College and Liberty University -- are. Work-study awards are not given upfront like scholarships and grants. In most cases, they are an offer to earn up to the awarded amount if you secure an eligible work-study job. While there is a misconception that all work-study jobs must be on campus, students can work for off-campus, nonprofit or public employers as long as the work is in the public's interest. You may be able to work for a for-profit employer if the job is relevant to your course of study. No matter who the outside employer is, it will need to have an established agreement with your college for you to receive work-study funds. Remember, to be eligible for federal financial aid, you must be enrolled and pursuing a degree or certificate. If you're not working toward a credential, Pell Grants and work-study won't be option, but you may still be able to take advantage of private scholarships -- just be sure to read the eligibility criteria carefully. [Explore what to know about financial aid in online programs.]-- Pay as you go: One of the great benefits to enrolling online is the flexible schedule, which can allow you to complete your college coursework around your responsibilities. But prospective students often overlook using their part- or full-time job earnings as an option for paying for college. Almost 80 percent of college students in 2015 worked at least part time while attending classes, according to the National Center for Education Statistics. By budgeting and thinking strategically about your college costs, you can likely reduce your dependence on student loans by paying a portion out of pocket. Many -- but not all -- online programs are less expensive than traditional programs and often have shorter payment periods. Six, eight or 10 weeks are common course durations. Because of the frequency of payments in an online setting, you may be well-placed to pay as you go and possibly avoid borrowing altogether. Attending college online and avoiding student loans may be challenging, but if you are willing to put in the effort, you can limit the amount you need to borrow. More from U.S. News Q&A: Understanding Student Loan Discharge Eligibility Student Loan Refinancing Isn't Right for All Borrowers
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