From a Laboratory to a Factory - IPBO |...

© 2017 Oxitec Limited

IIBN Forum, 10th May 2017

Biotechnology: From Innovation to Industrial Production

Amandine, R&D Team Leader

From a Laboratory to a Factory


What does Oxitec do?

We combat insect-borne diseases and improve crop yields

through the reduction of the insect populations

with a genetic approach that is safe, sustainable, economic and applicable to many insect species worldwide


Oxitec’s portfolio

Target Crop

MedflyCitrus/pome/

stone fruit

Olivefly Olive

Diamondback Moth

Brassica

Pink Bollworm

Cotton

Target Attacks

Drosophilasuzukii

Soft fruit

Stable flyHuman &livestock

Agriculture

In development

Target Vector of

Aedes aegypti

Yellow fever, Dengue, Zika

& Chikungunya

Aedesalbopictus

Dengue, Zika, &

Chikungunya

Public Health


Oxitec Ae. aegypti development

2002OX513A created

2009 -Grand Cayman

trial: 96% suppression

2010 -Brazil

Three trials: All >90%

suppression

2014Panama trial +

No Ae. albopictus niche replacement.

No persistence in the environment

2014-2016Brazil: CTNBio Approval, ANVISA

announced they will issue a temporary registration

US: FDA Publish FONSI & EA

Global: WHO PAHO/CARPHA recommend pilot deployment under operational conditions

Piracicaba project (65,000 people)

Cayman project


Oxitec OX513A Friendly™ mosquitoes

Offspring die before they can reproduce and transmit disease

Oxitec male mosquitoes are produced for release and mate

with wild females

Self-limiting Gene Fluorescent Marker Gene


Oxitec’s technology

Self-limiting Male-selecting

• Population suppression through ‘genetic sterility’

• Male-only releases• Population suppression via

death of female progeny

Transgenic male insects are released to mate with wild females. Death of progeny leads to population suppression.


tTAV tTAV works in a positive feedback loop to make more tTAV

Transcriptionalmachinery

tTAV stops the mosquito from expressing essential genes

Pest mosquito offspring die before they can reproduce

In a production environment Tetracycline is added through the diet to block tTAV action and this allows large scale production

Self limiting technology


Oxitec’s insects reviewed by independent regulators

Regulatory precedents across all Oxitec GM insects

Oxitec Aedes aegyptireceived approval for outdoor releases in Brazil April 2014

Import and contained trials approved

• Australia• Austria• France• Greece• Guatemala• Mexico

• Israel• Singapore• Thailand• Vietnam• UK

Current applications for outdoor release

• India• Caribbean• USA

Outdoor release approved

• Brazil• Cayman• Malaysia• USA• Panama

FDA Publishes Findings of

No Significant Impact on Oxitec’s Self-limiting

Mosquito


The growing global threat from Ae. aegypti

• Aedes aegypti vectors dengue, chikungunya and emerging Zikaviruses

• Dengue, chikungunya and Zikahave overlapping symptoms

• Dengue haemorrhagic fever can result in mortality

• Zika virus has been linked to microcephaly and Guillain-Barrésyndrome

• Yellow fever increase with 200,000 cases and 30,000 deaths worldwide annually*

US$39 bn global economic impact

231 cases of Dengue in La reunion in 2016

* Sources: http://www.who.int/ith/updates/20170404/en/


Invasive mosquitoes in Europe

Ae. aegypti

Ae. albopictusin Europe


Current 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’s OX513A self-limiting strain


Oxitec’s OX513A self-limiting strain

Site Date

Number of

OX513A males

released (millions)

Grand Cayman 2010 3.3

Itaberaba (Brazil) 2010-2011 17.64

Mandacaru (Brazil) 2011-2012 10.33

Jacobina (Brazil) 2013-2015 70.68

Nuevo Chorrillo

(Panama)2014 4.25

Piracicaba (Brazil) 2015 – ongoing 123.1

Total 229.3


Beyond a trial: Scaling up production

• Industrialized production

– Efficient, clean processes

– Quality controlledoutputs

• Capacity:

– Space >5,000m2

– 60 million malemosquitoes/week

Scaling up production - Brazil


Inside our Brazil factoryOpened large-scale facility in Brazil

Capacity of new factory in Piracicaba, Brazil is 60 million Oxitec mosquitoes per week


Release is planned and adaptive to needsRelease is planned and adaptive


Oxitec Mosquito Trial Results Summary

Cayman: Mosquito Research Control UnitBrazil: University of São Paulo and MoscamedPanama: The Gorgas Institute

96%

92%

99%

93%

93%

>90%1 suppression of Aedes aegypti in field

trials and projects across Cayman Islands,

Brazil, and Panama

1 Relative to control sites


Oxitec added strengths

Targeted, cost-effective approach• Males actively seek females• No radiation: No irradiators, lower costs• Demonstrated field effectiveness

Safety• Approved by regulators• Male focused releases • Fluorescent marker: track & trace• Non toxic, non allergenic

Environmentally-friendly strategy • No chemical residues• No adverse impact on non-target species • Not persistent in the environment• Built-in biosecurity

http://beecontrolnw.com/bumble-bees/3307689


Mosquito Vectors

Ae. aegypti:

Dengue

Chikungunya

Zika

Anopheles species:Malaria

Ae. albopictus:

Dengue

Chikungunya

Zika?

Culex species:

West Nile

Avian malaria


GM approaches

GM crops Oxitec insects GM -Gene Drive

• Genetic change to food

and feed product

• Genetic change to pest

only

• Genetic change to pest

only

• Unlikely to spread

• Self-limiting • Not self-limiting

• Genes do not pass to

other species• Designed to spread

within a species

• Commercial scale

monitoring and

widespread regulatory

approval

• Simplified monitoring

(fluorescent marker)

• Regulatory approvals

• Need to monitor

carefully

• Uncertain regulatory

path


Photo credit: Alexandre Carvalho/Oxitec Photo credit: Alexandre Carvalho/Oxitec

Cayman Islands

Support Neutral Oppose

Piracicaba, Brazil

Support Neutral Oppose

United States

Support Oppose

Surveys Show Strong Consumer Support

Monroe County referendum 2016 : 31 of 33 precincts voted in favour of trialling Oxitec’s solution


Any Questions?

Thank you!

From a Laboratory to a Factory - IPBO |...

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