Oxitec Mosquito Vector Control Technology. A New Paradigm to combat Dengue, chikungunya and the emerging threat of Zika

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Transcription:

Oxitec Mosquito Vector Control Technology A New Paradigm to combat Dengue, chikungunya and the emerging threat of Zika

2 Mosquitoes The World s Deadliest Animal

The Impact of Zika on the Health System the Environment, National Economy, and International Travel Is Growing Pics 1-4: Lianne Milton/Panos Pictures for The Washington Post Ernesto Benavides/Agence France-Presse Getty Images 3

March 2016 research article regarding Zika virus pandemic 4 http://currents.plos.org/outbreaks/article/on-the-seasonal-occurrence-and-abundance-of-the-zika-virus-vector-mosquito-aedes-aegypti-in-the-contiguous-united-states/

USA Travel related Local transmission Pregnant Guillain-Barré US mainland 388 33 1 Of which Florida: 84 5 Territories 3 500 48 4 CDC 20 th April 2016 Governor Scott directed the State Surgeon General to issue a Declaration of Public Health Emergency for the counties of residents with travel-associated cases of Zika. The Declaration currently includes the 15 affected counties: Alachua Brevard Broward Clay Collier Hillsborough Lee Miami-Dade Orange Osceola Palm Beach Polk Santa Rosa Seminole St. Johns 5

The Current Insecticide Model for Mosquito Vector Control Challenges + Inadequate control + Insecticide resistance + Public concerns about health effects and impacts on the environment and other species Example of Mosquito Eradication in a School Room

Oxitec Development History Pink bollworm OX513A Brazil factory 2002/4 2005/7 2008/9 2010/12 2013 2014 2015 Company formed as spin out from Oxford University Technology platform developed and exemplified in both agricultural and mosquito species Global first release of a GE insect Pink Bollworm (marker only) in USA Mosquito development spurred by Gates funding First outdoor release of OX513A mosquito in the Caymans Environmental Impact Statement in the USA environmentally preferred solution First outdoor release of OX513A in Brazil First agricultural collaborations Oxitec Brazil established Outdoor trials of OX513A in Panama and Brazil First larger scale urban project starts in Jacobina, Brazil First agricultural strains into development Medfly, DBM & Olive fly Oxitec Brazil National Biosafety approval in Brazil Panama outdoor trial USDA approval for agriculture trial in USA Brazil approval for agricultural trial First direct projects OX513A Brazil WHO VCAG recommendation for large scale Oxitec acquired by Intrexon to accelerate development 7

How Oxitec s Technology Works Inject genes into insect egg Oxitec male mosquitoes are produced for release and mate with pest females Self Limiting Gene + Inherited and offspring do not survive to adulthood + Repressed with an antidote during male insect production, allowing low cost multiplication + After releases stop, genes do not persist in the environment Fluorescent Marker Gene + Fluorescent protein detected by special light + Monitoring of pest population suppression + Releases adjusted in nearly real time + Track and trace capability Offspring die before they can reproduce and transmit disease 8

Key Benefits Efficiency Safety + Targeted delivery: males are attracted to wild females whose offspring die at the larvae and pupal stage (consuming resources along the way) + Insects and offspring contain a marker gene that is easy to monitor - track and trace + Local deployment by local people + Male-only releases (only female mosquitoes bite) + Genetic change is not toxic or allergenic Environment + Species-specific pest control, no off-target effects + Reduction of Aedes does not impact insects or other animals that may feed on Aedes + Neither insects nor progeny persist over time in the environment

Promising Suppression Results Ongoing in Piracicaba, Brazil Reduction in wild mosquito larvae by 82% + Oxitec and Piracicaba City Hall are expanding the Friendly Aedes aegypti Project in Piracicaba, Brazil + Oxitec is planning a new mosquito production facility in Piracicaba 10

Oxitec Mosquito Trial Results Summary 96% Cayman Islands 93% 92% Pedra Branca Up to 90+% suppression of Aedes aegypti in selected field trials and projects Panama 93% 99% Cayman: Mosquito Research Control Unit Brazil: University of São Paulo and Moscamed Panama: The Gorgas Institute Itaberaba Mandacaru 11

Attacking Global Epidemics at the Source: Brazil Case Study Early 1970s + No Aedes aegypti + No dengue Recent years + 1.5 million cases of dengue in 2015, up 176% y-o-y with 811 dengue-related deaths + First local transmission of chikungunya in 2014 and Zika virus entered in 2015 + Over $1 billion spent on the dengue vector control program annually Oxitec in Brazil 2011 to Present + Trials 2011 13 + National Biosafety Approval granted 2014 + Oxitec do Brasil established + In April 2015, Piracicaba became world s first municipality to release Oxitec mosquitoes operationally project now being expanded 96% of local Piracicaba residents support the Oxitec program Brazil press describe Oxitec solution as Aedes aegypti do bem: the good mosquito

Oxitec in Florida A New York woman caught dengue while vacationing in Key West. The first case of dengue in the area since 1933. Dengue was transmitted to an additional eighty-seven people in the area between 09 and 10. Oxitec applies to the Food & Drug Administration for permits to hold a field study in Key West, Fla. The Food & Drug Administration issues a finding of No Significant Environmental Impact from a proposed field study. 2009 2010 2011 2012 2013 2014 2015 2016 The Key West Mosquito Control District contacts Oxitec to explore new solutions to control the Aedes Aegypti mosquito. Key West proposes using Oxitec genetically modified mosquito to stop the Aedes Aegypti mosquito 13

Rigorous evaluation by independent experts + Detailed regulatory dossiers submitted and approved in multiple countries + National Biosafety Commission in Brazil approved Brazil-wide use in April 2014 + FDA-CVM publication of preliminary EA with FONSI March 2016 + WHO recommendation for OX513A March 2016

Strong Consumer Support Piracicaba, Brazil Florida, USA Support Neutral Oppose Support Neutral Oppose + Pre-zika outbreak surveys above show strong support + Post-zika Purdue study 78% support in USA * 15 * https://www.purdue.edu/newsroom/releases/2016/q1/survey-public-supports-use-of-gmo-mosquitoes-to-fight-zika-

16 Production and Release More than 130 million Oxitec mosquitoes released worldwide

Global Supply Vision Global facilities produce eggshighly durable and can ship globally Regional and local facilities prepare pupae and distribute. 17

Summary + Oxitec now wholly-owned by Intrexon, a U.S. company with the expertise, scale, and determination to execute on significant global issues + Oxitec has had field success supressing the pest populations of Aedes aegypti of up to 90+% + Current results have proven entomological end points + CTNBio in Brazil have approved the Oxitec mosquito (OX513A) from an efficacy and environmental safety perspective for commercial application + FDA-CVM have issued a preliminary Finding of No Significant Impact + WHO have made a recommendation for pilot deployment + Oxitec has solutions that apply to Aedes albopictus as well + The technology is compatible with current interventions and would be synergistic with future vaccine and therapeutic drug interventions 18

19 StopTheMosquito.com

20 QUESTIONS?