Public-private partnerships in advancing Ebola treatment pipeline

The spread of the Ebola virus (EVD) continues to capture world headlines. It has also become of great concern in the United States where 4 cases have now been confirmed.

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Currently, there are no FDA-approved vaccines or drugs for EVD.¹ The need for effective therapeutic approaches is increasingly vital, yet the research dollars have not been forthcoming.

A recent report from GlobalData underscores the relative lack of response by pharmaceuticals, attributed to EVD’s low incidence to date and its main outbreaks occurring in impoverished countries that cannot pay for expensive drugs.² Neither circumstance makes drug development for EVD financially attractive. Clinical studies are also difficult to design and carry out due to the rapid onset of severe symptoms in patients with EVD and a mortality rate of about 50%.^2,3

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The GlobalData report proposes that the way around this disconnect is to have companies incentivized by governments and healthcare policymakers that can help alleviate “the risks and up-front costs associated with drug development.”²

“So far, clinical-stage experimental treatments for Ebola have all been advanced, at least in part, with the financial support of public entities,” said Daian Cheng, PhD, the company’s analyst covering infectious diseases. Cheng added that “the contribution to R&D has only increased as fears of the virus have spread.”⁴

Indeed, cooperative efforts between the public and private sectors are ongoing. Among drugs now in the EVD pipeline is the therapeutic vaccine cAd3-ZEBOV (GlaxoSmithKline) developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a Swiss-Italian biotech company acquired by GlaxoSmithKline in 2013.^1,2,5 It is currently being evaluated in a phase 1 study including healthy volunteers begun in early September, and it is hoped that results on safety and dosing will be available by year’s end.^1,2 The study and initial manufacturing costs are being funded by an international consortium of governmental bodies and research institutes.²

Another potential EVD vaccine is rVSV-ZEBOV, developed by the Public Health Agency of Canada, with US-based biotech NewLink Genetics holding its license.^1,2 Phase 1 studies will soon begin to evaluate safety and dosing.² A two-vaccine combination against EVD is also being developed by Johnson & Johnson in collaboration with NIAID and privately held Bavarian Nordic. A phase 1 study is planned to begin by early next year.^2,6 Finally, Atlanta-based GeoVax Labs is working with the CDC to develop two experimental EVD vaccines: GOVX-E301 and GOVX-E302.¹

Experimental therapeutics in process for EVD include ZMapp (Mapp Biopharmaceutical), which was developed with public funds and has been given support in production by various organizations and government agencies.^1,2 Another is the RNA interference antiviral agent TKM-Ebola (Tekmira Pharmaceuticals). Its phase 1 study, however, supported by US Department of Defense BioDefense Therapeutics, was later suspended by FDA.^1,2 Broad-spectrum antiviral agents that could combat EVD include brincidofovir (Chimerix) and favipiravir (Fujifilm Holdings); both drugs have shown promise in treating EVD.²

According to the World Health Organization (WHO), 4493 people have died from Ebola through October 12^th of this year in Guinea, Liberia, Nigeria, Senegal, Sierra Leone, Spain, and the US. EVD cases in healthcare workers amounted to 427 during this time, including 236 deaths.³ WHO estimates there may be 10,000 new cases of EVD per week in Sierra Leone, Liberia, and Guinea by the end of 2014.

References

1. National Vaccine Information Center. Sterling, VA. October 16, 2014. http://www.nvic.org/vaccines-and-diseases/Ebola.aspx.  Accessed October 16, 2014.

2. GlobalData. Advancing the Ebola pipeline requires continued collaboration between public and private stakeholders. October 2014. Accessed October 15, 2014.

3. World Health Organization. WHO: Ebola response roadmap situation report. October 15, 2014. Accessed October 15, 2014.

4. GlobalData. (press release) Public-private partnerships vital to advance Ebola treatment pipeline, says GlobalData analyst. October 15, 2014.

5. National Institute of Allergy and Infectious Diseases. Vaccine Research Center (VRC). Ebola vaccine development. http://www.niaid.nih.gov/about/organization/vrc/research/Pages/Ebola.aspx. Accessed October 16, 2014.

6. Johnson & Johnson. (press release). Johnson & Johnson responds to Ebola crisis with commitment to accelerate vaccine program in collaboration with the US National Institutes of Health (NIH) and provide humanitarian relief aid. September 4, 2014.

 http://www.jnj.com/news/all/Johnson-Johnson-Responds-to-Ebola-Crisis-with-Commitment-to-Accelerate-Vaccine-Program-in-Collaboration-with-the-US-National-Institutes-of-Health-NIH-and-Provide-Humanitarian-Relief-Aid. Accessed October 16, 2014.