VSV-ZEBOV Launches U.S. Trials; J&J, Bavarian Nordic eye 1M doses; ChAd3-EBOV among EC grant winners; Army funds Profectus
The global cost of preventing and containing Ebola will soar to $5.9 billion by 2016, Frost & Sullivan projects in a new video. A key reason why, the consultancy contends, is U.S. regulatory red tape delaying commercialization of new rapid diagnostics.
Aishwarya Vivekanandan, a Frost & Sullivan analyst, said CDC should relax its requirement for central-lab processing of results, while FDA should speed up decisions on Ebola diagnostics—as the agency approved on an emergency basis experimental treatments such as Tekmira Pharmaceuticals’ TKM-Ebola vaccine and Chimerix’s drug brincidofovir.
Vivekanandan cited BioFire Defense, a bioMérieux subsidiary whose PCR-based FilmArray system can detect Ebola in under an hour. On Saturday the FDA told healthcare providers it gave Emergency Use Authorization (EUA) for the use of FilmArray NGDS BT-E Assay with the FilmArray instrument to test for Ebola Zaire virus.
While Emory Healthcare used FilmArray to diagnose the first two U.S. Ebola patients this past summer, Texas Health Presbyterian Hospital-Dallas could not do likewise in treating Thomas Eric Duncan,because its system was research-use only—and would have required a 10-20 day wait before clinical use, BioFire told defense news website DefenseOne.
Vivekanandan also cited Roche. Ronald Diggelman, COO of Roche’s diagnostics division, told analysts October 16 the company is assessing whether to request FDA emergency approval for its Ebola test. The test can run on Roche’s LightCycler 480 and cobas z 480 real-time PCR systems.
“With an epidemic on our hands, our strict guidance must change to increase our efficiency in diagnosing Ebola,” Vivekanandan said.
$129M COMMITTED: Prime Minister David Cameron said October 23 the U.K. will commit £80 million ($128.8 million) to fight Ebola. Most of the money—some £50 million ($80.5 million)—will be spent to create 200 Ebola care units in Sierra Leone, allowing individuals who suspect they have the virus to be examined and, if needed, isolated.
Of the remainder, £20 million ($32.2 million) will be set aside for the UN Ebola Multi-Partner Trust Fund, established to fight the disease by UN Secretary General Ban Ki-Moon, and £10 million ($16.1 million) toward burials of Ebola victims.
Cameron said the U.K. has spent £125 million ($201 million) to date fighting Ebola, and has urged European leaders to set aside a combined £800 million (about $1.3 billion).
$100M MORE: Paul G. Allen, the Microsoft co-founder-turned-philanthropist, said October 23 he has raised his investment in the fight against Ebola to $100 million, toward several efforts:
- Developing and manufacturing two medevac containment units, for U.S. State Department use in evacuating medical professionals.
- Joining with the World Health Organization (WHO) to enhance its capacity to coordinate logistics involved in transporting aid workers.
- Establishing the $2.5 million Ebola Medevac Fund to address the gap between insurance coverage and transport costs. Grants will be matched by the Paul G. Allen Family Foundation.
- Helping provide training, medical workers and lab equipment for relief efforts in Liberia, through a donation to University of Massachusetts Medical School.
- Launching the online donation platform TackleEbola.com, designed to coordinate and optimize individual global giving toward solutions to treat, contain and prevent the spread of Ebola.
VSV-ZEBOV: The Ebola vaccine candidate developed by Canadian and U.S. researchers has begun trials stateside and has been distributed to the WHO for trials in Switzerland starting November 1.
At NIH’s Clinical Center, researchers from the National Institute of Allergy and Infectious Diseases (NIAID) on October 22 began conducting a Phase I trial of VSV-ZEBOV for safety and immunogenicity in healthy adults through a prime-boost strategy. The Walter Reed Army Institute of Research is simultaneously testing the vaccine candidate as a single dose at its Clinical Trials Center.
VSV-EBOV was developed by the Public Health Agency of Canada (PHAC), and has been licensed by PHAC to BioProtection Systems, a subsidiary of NewLink Genetics.
On October 20, the first of 800 vials of VSV-EBOV were shipped to the WHO, which will begin its own clinical trials in Lausanne, Switzerland. Results are expected in December. Should the vaccine succeed, it would be shipped in January to African countries stricken with Ebola.
J&J/BAVARIAN NORDIC: Johnson & Johnson (J&J) has committed $200 million to speed up and expand its production of an Ebola vaccine regimen in development at J&J’s Janssen Pharmaceutical Cos.
The prime-boost regimen—discovered through collaborative research with the NIH—combines J&J vaccine components including AdVac® technology from Crucell Holland, part of J&J’s Janssen Pharmaceutical Cos., and Bavarian Nordic’s MVA-BN® Filovirus vaccine candidate.
According to J&J, the combination has shown promising results in preclinical studies, and is to be tested for safety and immunogenicity in healthy volunteers in Europe, the U.S., and Africa starting in early January.
Bavarian Nordic on October 22 committed to making available more than 1 million doses of MVA-BN over the coming year, with J&J also targeting production of 1 million doses of its regimen components—including 250,000 doses by May 2015 for trials.
$31M FROM EC: The European Commission said October 23 it will spend €24.4 million ($30.9 million) from the Horizon 2020 funding framework toward five Ebola research projects:
- EbolaVac (GlaxoSmithKline Biologicals)—€15,153,216 ($19.2 million) for clinical trials in Europe and Africa on ChAd3-EBOV, for which a clinical study was launched earlier this month in Mali.
- Ebola_Tx (Prins Leopold Instituut voor Tropische Geneeskunde)—€2,892,171 ($3.7 million) to study use of whole blood or plasma from survivors as an Ebola treatment.
- REACTION (INSERM)—€2,575,810 ($3.3 million) to study safety and efficacy of Favipiravir, in an animal model and in patients with Ebola.
- IF-EBOla (Institut de Recherche pour le Developpement)—€1,992,770 ($2.5 million) to study safety and efficacy of using antibodies produced in horses against Ebola.
- EVIDENT (Bernhard-Nocht-Institut fuer Tropenmedizin)—€1,759,326 ($2.2 million) to study disease-host interactions.
VESICULOVAX™: Profectus BioSciences and the Galveston National Laboratory (GNL) at the University of Texas Medical Branch at Galveston (UTMB) received a three-year $8.5 million grant from the U.S. Department of the Army, for support studies toward development of the vaccine candidate.
VesiculoVax is designed to provide pre- and post-exposure protection against all major Ebola and Marburg virus strains. The experimental vaccine uses recombinant vesicular stomatitis virus (rVSV)-based vectors engineered to express the surface glycoproteins used by Ebola and Marburg to recognize a host cell, bind to it, and infect.
Profectus, which announced the grant on October 22, cited NIH studies in nonhuman primates that showed VesiculoVax to provide rapid protection against hemorrhagic fever viruses. The experimental vaccine is the only one to demonstrate single-dose protection of monkeys from low-passage Ebola and Marburg, the company said.
TKM-EBOLA: Tekmira Pharmaceuticals has begun limited GMP manufacture of a new RNAi therapeutic targeting the Ebola-Guinea variant linked to the outbreak in West Africa. TKM-Ebola will be available in early December, Tekmira said October 21.
Tekmira also said it expected “this quarter” to resolve the partial clinical hold placed by the FDA on its IND for TKM-Ebola, specifically the multiple ascending dose portion of a Phase I clinical study. The hold was modified in August from a full hold, allowing for use of TKM-Ebola in patients with confirmed or suspected virus infection.
TKM-Ebola is being developed by Tekmira and the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems.