Diagnosis Kit for Leishmaniasis

10 years of collaborative research

Parasite

sandfly

“Increasingly, there is evidence that clinical cases of leishmaniasis represent the tip of an ‘infection iceberg”

www.eurosurvaillance.org, Sept. 2013

PROBLEM

1.4 M infected people every year*; 25 000 human deaths every year*

Now spreading due to global warming

* Jan 2014

PROBLEM

5

Manufacturer Product name Bound

Antigen

Application Time Leishmaniasis

type

Test Web site

Bio-Rad Laboratories DiaMed-IT LEISH rK39 Human na Visceral L. IC http://www.diamed.com.br/cmi/Pagina.aspx?306

CTK Biotech, Inc OnSite Leishmania Ab Rapid Test rK39 Human 15 min Visceral L. IC http://www.grupolabca.com.mx/laboratorios%20clinicos/pruebas%20rapidas/ct

k%20inserts/R0122C.pdf

Span Diagnostics, Lda Crystal KA (Kala azar) rKE16 Human 15 min MucoCutânea IC http://www.dpcleb.com/product/view/204

InBios International Inc Kalazar Detect™ rK39 Human 10 min Visceral L. IC http://www.inbios.com/rapid-tests/kalazar-detect

InBios International Inc Canine Visceral Leishmaniasis Dipstick* rK39 Dog na Visceral L. IC http://www.inbios.com/veterinary-reagent-controls/canine

Vtrade Anigen Rapid Leishmania Ab Test Kit na Dog 20 min Visceral L. IC http://www.vtrade.be/nl/main/gamma/rapid-tests/test-rapide-kitvia-v600920-

leishmaniose-eng.pdf

BIONOTE Anigen Rapid Leishmania Ab Test Kit na Dog 20 min Visceral L. IC http://www.bionote.co.kr/ANIMAL/ENG/Production/canine.asp?LT=2&MODE=V

&bIdx=165&bcIdx=9&P=2&BLT=L&PC=20&gAIdx=&gSearchText=

Virbac Animal Health Speed Leish K Kinesin

Capture

Complex

Dog 20 min Visceral L. IC http://en.bvt.fr/p-bvtfrpuben/display.aspx?srv=p-

bvtfr&typ=pub&lang=en&cmd=view&style=styles/specie.xsl&select=PRODUCT%5

B@ID$eq$PRODUCT_98%5D

Bio-

Manguinhos/Fiocruz

DPP® Canine Leishmaniasis rK39 Dog 15 min Visceral L. IC https://www.bio.fiocruz.br/en/index.php/products/ivd-tests/rapid-tests/dppr-

canine-leishmaniasis

Biogal, Galed Labs. ImmunoRun na Dog 5-20 Visceral L. IC file:///C:/Users/camorim/Downloads/ircli155.01.12.11%20(2).pdf

Quicking Biotech Canine Leishmania Antibody Test HRPO

Conjugate

Dog 10 min Visceral L. IC http://en.quicking.cn/Products/Pet/Canine/Enquicking12.html

EcoDiagnóstica Leishmania Ab na Dog 10 min Visceral L. IC http://www.ecodiagnostica.com.br/produto/leishmania-ab

PROBLEM

6

.....but only some of the antibodies can be detected by the existing diagnostic kits, drawbacks:

• 40% false results •Individuals without clinical signs are not detected

PROBLEM

Diagnostic kit

.....but only some of the antibodies can be detected by the existing diagnostic kits, drawbacks:

• 40% false results •Individuals without clinical signs are not detected

PROBLEM

An innovative combination of several proteins …

Quantitative Electronic Reader

Probe

LEVDS

SOLUTION

Quantitative Electronic Reader

9

“I think that what is really important, is to have a quantitative kit” ; Luis Cardoso, PhD (Opinion Leader, Veterinary School in the endemic northern region of Portugal)

…able to reduce 10x the false negatives Probe

LEVDS

SOLUTION

• Regulatory hurdles : Shorter Independent certification Easier authorization of ethical committees Simpler requirement to Infarmed • Shorter time to market • Earlier revenues help the funding of the development of the solution for humans

“Disease can be controlled if infected dogs are identified” (WHO, 2014)

Pet dogs

LEVDS

MARKET

30M South of Europe

Total pet dogs 223M India 10 M

Brazil 36 M

Europe 66 M

There are 2.5 M dogs in Europe already infected ; 2 M vaccine shots

Entry market

MARKET

15M dogs with Veterinary Care

• Anabela Cordeiro da Silva (FFUP/IBMC/i3S)

• Célia Gomes Amorim (FFUP/ IBMC/i3S) …“over 20 years of cumulative experience in research”

TEAM

Winner of the Grand Prix - 10th Edition of National Inovation Contest

AWARD

INCENTIVES FOR INNOVATIVE

AVISO SI-47-2015-33-

Incentive Scheme for Research and Technological Development (R & TD)

Projects Co-Promotion

2022 2021 2020 2019 2018 2017 2016 2002 …

ROADMAP

R&D + Proof of Concept

McS

Regulatory Approvals Business Partnerships

Market Development

Market Development

Launch Product PT, SP, FR, IT

Launch Product BR

Previous research investment

450K€ 300K€ 1 M€

Product develp

2022 2021 2020 2019 2018 2017 2016 2002 …

R&D + Proof of Concept

ROADMAP

LEISH KIT FOR HUMANS *

2022 2021 2020 2019 2018 2017 2016 2002 …

ROADMAP

McS

Regulatory Approvals Business Partnerships

Market Development

Market Development

Launch Product PT, SP, FR, IT

Launch Product BR

Product develp

R&D + Proof of Concept

EXIT STRATEGY