J&J, GSK, Tekmira, And Others Take Next Steps To Fight Ebola

Xconomy Boston — 

There’s been distressing Ebola-related news in recent days. The deadly virus continues to spread in West Africa, with more than 4,500 fatalities now reported, and efforts to halt its spread in the U.S. have been mired in controversy and confusion, forcing President Obama to appoint an Ebola “czar” to coordinate national response.

But there’s good news, too. The World Health Organization declared Nigeria Ebola-free after 19 reported cases. In the pharmaceutical world, there has also been progress from several companies, ranging in size from giant to startup. We’ll start at the top of the scale.

—GlaxoSmithKline (NYSE: GSK) CEO Andrew Witty said Wednesday that an “initial supply” of its Ebola vaccine, which it is developing and testing with help from the National Institutes of Health and other agencies, should be available before the end of 2014. The vaccine has begun Phase 1 safety trials in humans in the U.S., United Kingdom, and Mali. If all goes well, the company would like to start vaccinating healthcare workers in Sierra Leone, Liberia, and Guinea early next year.

—There’s more pharma news, this time with deal activity, which doesn’t happen often in this corner of the drug world. Johnson & Johnson (NYSE: JNJ) wants to start human clinical trials and offer an Ebola vaccine for emergency use in 2015. It has worked with Denmark’s Bavarian Nordic to develop a trivalent vaccine, aimed to prevent infection from the Zaire and Sudan Ebola strains and the Marburg virus, which like Ebola is in the filovirus family and causes a hemorrhagic fever.

Now J&J has put significant cash behind the collaboration. It has licensed the vaccine from Bavarian, paying $25 million up front, with milestones and royalties on sales outside Africa—a sign that companies now see a business case for Ebola products in Western markets.

In addition, Bavarian says it will deliver 1 million doses to J&J for $70.8 million up front and $28.5 million next year. There’s one more financial component to the deal: Johnson & Johnson Development Corp., the company’s venture group, will buy approximately $43 million worth of Bavarian Nordic shares. The companies have been working to combine the trivalent vaccine with technology from J&J’s Crucell group. Animal testing of the combination has shown complete protection against Ebola, the companies said Wednesday.

—More vaccine news came Wednesday from Baltimore, MD-based Profectus Biosciences, which has received two U.S. government grants totaling $17.1 million to push its program forward. (For more on U.S. government incentives to spur Ebola treatment, read my column from last month.) The cash comes from the departments of Defense and Health and Human Services, and will help the privately held Profectus test its vaccine against the Zaire strain in monkeys at one of the nation’s top infectious disease research labs in Galveston, TX. The test starts this week.

Like Bavarian Nordic, Profectus aims to produce a trivalent vaccine against the Zaire and Sudan strains of Ebola and Marburg, but first it must get through the Zaire trial in monkeys and move that vaccine into a small human trial, which could start as early as July, Profectus chief scientific officer John Eldridge said.

Profectus’s development of a trivalent vaccine stems from government concern that Ebola and other deadly viruses can be turned into weapons against soldiers and civilians. The Defense Department was “explicit about its requirement,” Eldridge said. “Up until less than a year ago, the majority of funding and attention in the field really came from the potential of these viruses to be used as bioterror weapons.”

“The end game is the trivalent vaccine,” Eldridge said. “The Ebola Zaire and Sudan strains are at opposite ends of a ‘spectrum,’ and most other [strains] are between them.”

The hope is that providing a vaccine against both, plus Marburg, would “provide protection against all challenge strains to date,” Eldridge said.

—Late Tuesday, Tekmira Pharmaceuticals (NASDAQ: TKMR) of Vancouver, BC, announced that it has begun a limited manufacturing run of its TKM-Ebola treatment—meant for people already infected or suspected to have infection. The treatment is specifically tailored to fight the strain of the virus responsible for the current outbreak. The company statement said supply of the drug should be available in December. In late September the drug, which is not currently allowed to be tested in clinical trials, got a green light from regulators for emergency use, and Tekmira said “a number of patients” had been treated with it. They include Richard Sacra, a doctor who was infected in Liberia and successfully treated back in the U.S. Xconomy reported on Tekmira CEO Mark Murray’s public appearance earlier this month.

Other companies working on Ebola drugs or vaccines include NewLink Genetics of Ames, IA, Chimerix of Durham, NC, and Mapp Biopharmaceutical of San Diego.