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อังคาร, 04 พฤศจิกายน 2014

GEN News Highlights : Nov 3, 2014

  • Alex Philippidis

Drug developers specializing in Ebola treatments won’t likely need a blockbuster treatment to succeed at capitalizing on the West Africa outbreak. Ebola is likely to join anthrax and smallpox as the next infectious disease to compel the awarding of billion-dollar-plus government contracts by the U.S. alone, according to a Credit Suisse presentation.

“It is unlikely that Ebola will emerge as a viable standard commercial model for drug sales,” Credit Suisse concluded in “The Ebola Crisis,” presented Monday by research analyst Jason Kantor, Ph.D., and research associate Jeremiah Shepard, Ph.D. “The real economic ‘win’ for biotech and pharmaceutical companies will come in the form of government procurement contracts to stockpile and deploy countermeasures.”

Government agencies involved in countermeasure development and procurement “are well established and have the regulatory and financial tools to address the crisis,” the presentation found.

It cited CDC—despite public criticism of its handling of U.S. Ebola cases—as well as FDA, NIH and its National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority, the U.S. Department of Defense (DoD), the U.S. Department of Health and Human Services, and the U.S. Army Medical Research Institute of Infectious Diseases.

“We believe multiple U.S. Government procurement contracts for both vaccines and antivirals are likely to emerge as a result of the current Ebola outbreak, regardless of whether the outbreak is brought under control,” Drs. Kantor and Shepard added.

They expect Ebola to continue spreading: “Infection rate is in exponential phase in West Africa, suggesting the outbreak is likely to worsen.”

CROWDFUNDED FPLC: The Scripps Research Institute (TSRI) has raised more than $100,000 through online crowdfunding toward Ebola diagnostics for a consortium headed by a TSRI professor, Erica Ollmann Saphire, Ph.D. As of October 31, Scripps raised $101,574 through gifts ranging from $10 to $25,000.

Funds are being used to order two AKTA pure fast protein liquid chromatography (FPLC) systems from GE Healthcare Life Sciences. “These systems would supplement a FPLC system currently in use in Erica's lab,” TSRI spokeswoman Madeline McCurry-Schmidt told GEN.

Dr. Ollmann Saphire is among researchers from the consortium’s 15 institutions studying Ebola under a five-year, $28 million grant awarded in March under NIAID’s Centers for Excellence in Translational Research program (No. U19AI109762).

The consortium developed the experimental ZMapp serum used to successfully treat the first two American Ebola patients, Kent Brantly, M.D., and Nancy Writebol.

$100M MORE: The World Bank on October 30 committed another $100 million toward speeding up deployment of foreign health workers to Guinea, Liberia, and Sierra Leone, the three nations most affected by the West Africa outbreak. The new funds raise the World Bank’s funding toward fighting Ebola to more than $500 million.

According to the World Bank, the $100 million will benefit an operational hub to recruit, train, and deploy qualified foreign health workers. The hub will be designed and operated with the Senior United Nations System Coordinator for Ebola and the United Nations Mission for Ebola Emergency Response, with technical support from the World Health Organization (WHO) and other agencies.

$9.5M FOR VESICULOVAX™: Profectus BioSciences said Friday that it was awarded a $9.5 million contract by the DoD through its Medical Countermeasure Systems-Joint Vaccine Acquisition Program (MCS-JVAP) toward GMP manufacture and IND-enabling preclinical testing of a trivalent Ebola/Marburg vaccine, capable of fighting three major filovirus threats—Ebola Zaire and Ebola Sudan, as well as the Marburg viruses.

Profectus said funds would support manufacture of separate VesiculoVax-vectored vaccines for the three viruses, which would be blended into the trivalent formulation, then be assessed through a rapid Phase I clinical trial.

Battelle Memorial Institute has contracted with Profectus for manufacturing and clinical evaluation and with Charles River Laboratories and Biologics Consulting Group for preclinical testing and IND preparation, respectively.

The contract is the fourth awarded by the U.S. government this year to Profectus and partners toward Ebola research, totaling at least $49.8 million (and possibly $51.8 million if one of the contracts is extended).

$5M FOR rVSV-EBOV:  The Welcome Trust has awarded a £3.1 million ($5 million) grant to an international consortium to fund trials of the experimental Ebola vaccine developed by Canadian and U.S. researchers. The funds will be used to rapidly assess vaccine response, and determine an optimal dose for preventive intervention, the Trust said October 29.

A total 335 healthy volunteers are to be vaccinated—20 in Germany, followed by 100 each in Gabon and Kenya, then 115 in Switzerland. The consortium will use 800 vials donated by the Canadian government to the WHO. Trials of rVSV-EBOV have already begun in the U.S., focused on dosage safety and immunogenicity comparison of single-injection and prime-boost regimens.

rVSV-EBOV uses an attenuated version of live vesicular stomatitis virus (VSV). The vaccine candidate was developed by the Public Health Agency of Canada (PHAC), and licensed by PHAC to BioProtection Systems, a subsidiary of NewLink Genetics.

EBOV GP VACCINE: Novavax expects to initiate a Phase I clinical trial in December 2014 for its Ebola GP recombinant nanoparticle vaccine candidate (EBOV GP Vaccine), based on the 2014 Guinea Ebola strain believed responsible for the outbreak in West Africa. The vaccine—for which Novavax has already launched a nonhuman primate study—will be assessed in ascending doses, with and without the company’s Matrix-M™ adjuvant, in approximately 150 subjects.

In preclinical models, EBOV GP Vaccine with adjuvant Matrix-M enhanced anti-Ebola GP responses by 10- to 100-fold, and also induced anti-GP ELISA and neutralizing antibody levels well within ranges reported to protect against Ebola viruses in rodent and nonhuman primate models. Novavax disclosed its progress on EBOV GP Vaccine at the Eighth Vaccine and ISV Conference in Philadelphia on October 26.

CHEMBIO-IBT PARTNERSHIP: Chembio said it will combine its Dual Path Platform® (DPP) technology with Ebola reagents from Integrated BioTherapeutics (IBT) to develop a point-of-care (POC) diagnostic test for Ebola. Chembio also intends to include an Ebola test as part of its existing multiplex DPP Febrile Illness Assay, now in clinical trials in West Africa and several countries.

Chembio will have exclusive rights to any POC product developed through the agreement.  Financial terms of the agreement were not disclosed.

According to Chembio, DPP offers several advantages over lateral flow technology, including significantly increased analytical and clinical sensitivity, decreased overall assay interaction time, and an enhanced multiplex capability with independent and simultaneous delivery of samples.

IN THE GENES: Genetic factors appear to explain widely varying responses to Ebola infection, according to study findings based on a disease model in mice.

Michael G.  Katze, Ph.D., and Angela Rasmussen, Ph.D., both of the University of Washington, co-led researchers in studying “Collaborative Cross” mice with genetic diversity similar to humans. When infected with mouse-adapted Ebola, 19% showed complete resistance; 11% displayed partial resistance, with less than half of them dying; and 70% had severe symptoms, with more than half dying.

Within the severely ill, 34% had blood that took too long to clot, a hallmark of fatal Ebola in humans. Other severely ill mice showed internal bleeding, swollen spleens, and changes in liver color and texture. Results were published Thursday in Science.

AGE, VIRAL LOAD: Patients under age 21 were less likely to die from Ebola than those over age 45 (57% vs. 94%) among the first 106 patients diagnosed with the virus at Kenema Government Hospital in Sierra Leone between May 25 and June 18, 2014, according to a study published Wednesday in the New England Journal of Medicine.

The study also showed a link between mortality and virus load: Patients presenting with fewer than 100,000 EBOV copies per milliliter had a lower case fatality rate than those with 10 million EBOV copies per milliliter or more (33% vs. 94%).

$313K FROM MERCK KGaA: Merck KGaA said Friday it will donate €250,000 (about $313,000) to support the German Red Cross. In addition to supporting Red Cross organizations in Guinea, Liberia, and Sierra Leone, the company said the German Red Cross will use the funds to expand and enhance a treatment center for Ebola patients operated by the International Red Cross in Sierra Leone.

In Liberia, the German Red Cross will also begin operating a treatment center for Ebola patients, with support from the German military, starting in mid-November, Merck KGaA said.

IMI CONTRACTS COMING: The Innovative Medicines Institute (IMI) said Friday that it was preparing “an ambitious program to accelerate the development of vaccines and treatments against Ebola and other filoviral hemorrhagic fevers.” IMI said a fast-track call for proposals “is likely to be launched in the near future.”

Last Updated ( อังคาร, 04 พฤศจิกายน 2014 )
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