Cibler un antigène intracellulaire conservé pour améliorer la prévention de la grippe saisonnière - Journée Infections Nosocomiales 20 novembre 2018
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Cibler un antigène intracellulaire
conservé pour améliorer la prévention
de la grippe saisonnière
Journée Infections Nosocomiales
20 novembre 2018
Alexandre LE VERT
Co-fondateur et Président
alevert@osivax.com - +33 (0) 6 79 82 92 70
1
Disclaimer
• The material in this presentation has been prepared by Osivax and is general
background information about Osivax’s activities current as at the date of this
presentation. This information is given in summary form and does not purport
to be complete. Information in this presentation, including forecast financial
information, should not be considered as advice or a recommendation to
investors or potential investors in relation to holding, purchasing or selling
shares and does not take into account your particular investment objectives,
financial situation or needs. Before acting on any information you should
consider the appropriateness of the information having regard to these
matters, any relevant offer document and in particular, you should seek
independent financial advice. All securities and financial product or instrument
transactions involve risks.
• This presentation may contain forward looking statements including
statements regarding our intent, belief or current expectations with respect to
Osivax’s operations, and risk management practices. Readers are cautioned not
to place undue reliance on these forward looking statements. Osivax does not
undertake any obligation to publicly release the result of any revisions to these
forward looking statements to reflect events or circumstances after the date
hereof to reflect the occurrence of unanticipated events. While due care has
been used in the preparation of forecast information, actual results may vary in
a materially positive or negative manner. Forecasts and hypothetical examples
are subject to uncertainty and contingencies outside Osivax’s control.
2
Agenda
• La grippe, une maladie dévastatrice, mais dont la composante
nosocomiale est souvent sous-estimée
• Osivax, une société lyonnaise qui veut réinventer la vaccination contre la
grippe
3
The problem: Influenza is a devastating disease and a major pandemic threat
despite existing vaccines
Seasonal Influenza kills hundreds of Pandemic Influenza can cause
thousands of people annually tens of millions of deaths
1918 1957 1968 Future
290,000 to 650,000 Spanish Asian HK “Spanish”
deaths each year Flu Flu Flu Flu
Deaths:
36,000 to 65,000
50M 1-2M ~1M ~33M
deaths each year1 in 6 months3
Seasonal vaccines average efficacy of 41% Pandemic vaccines take
and only 25% for patients >65 yo2 6 to 9 months to become available
A paradigm shift is essential in influenza vaccination
1-https://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm
2-https://www.cdc.gov/flu/pdf/professionals/vaccination/vaccine-effectiveness-table-2016.pdf ;
https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2017-06.pdf
3-Source : Bill and Melinda Gates Foundation, casualties within the first 6 months of outbreak
4
Au-delà du nombre de mort, un impact très important en terme
d’hospitalisations
5
La grippe peut être une maladie nosocomiale dans les structures de soins,
transmise entre les patients et le personnel soignant …
> 20% du personnel soignant … dont plus de 50% … et donc un risque de
infecté chaque année… asymptomatiques … transmission significatif
Part des personnel soignant infectés
par la grippe sur une année (n=518)
13%
On estime que 90%
Syndrome
respiratoire des personnes
28% infectées excrètent
120 Pas de souvenir de
syndrome du virus, et que
respiratoire
Pas de syndrome
90% des personnes
59% grippal typique au contact d'un
sujet contagieux
398
vont s'infecter.
Infectées Personnel soignant infectés
(n=120)
Non infectées
Source : https://www.urofrance.org/nc/science-et-recherche/base-bibliographique/article/html/la-grippe-
nosocomiale-un-plaidoyer-pour-la-vaccination-anti-grippale-systematique-du-personnel-so.html
6
… et responsable d'une surmortalité et d'une morbidité importante (sans
parler de l’impact sur l’organisation des services hospitaliers)
• Surmortalité / morbidité importante pour les patients immunodéprimés
– En hématologie chez les patients recevant une allogreffe de moelle
• Taux de mortalité de 28% en cas de pneumonie grippale
– Chez les patients recevant une transplantation d'organe
• Taux d'incidence de la grippe de 41,8 cas pour 1000 personnes années pour les
receveurs de greffe de poumon
• Taux d'incidence de la grippe de 4,3 cas pour 1000 personnes années pour les
receveurs de greffe de rein
• Chez ces patients, la grippe est responsable de rejet aigu du greffon
• Désorganisation d’un Service de médecine interne
– 41% des patients contaminés ou infectés
– 23% du personnel soignant contaminés ou infectés
– Report de 8 admissions programmées, et arrêt de 11 jours des hospitalisations
en urgence
Source : https://www.urofrance.org/nc/science-et-recherche/base-bibliographique/article/html/la-grippe-
nosocomiale-un-plaidoyer-pour-la-vaccination-anti-grippale-systematique-du-personnel-so.html
7
La vaccination du personnel soignant, bien que recommandée, est très
largement sous implémentée
• Résultats d’une étude menée en Franche-Comté (CHU de Besançon et Dole)1
Le vaccin n'est pas fiable.
Plusieurs virus sont
responsables de la grippe.
Je laisse donc mes
anticorps faire leur boulot
J’ai a fait le choix de
ne plus me faire
vacciner car les
années où je l’ai
fait, j’ai été malade
1- La Vaccination Antigrippale des Professionnels de Santé – octobre 2007
https://drees.solidarites-sante.gouv.fr/IMG/pdf/Rapport_VAG.pdf
8La vaccination du personnel soignant, bien que recommandée, est très
largement sous implémentée
• Résultats d’une étude menée en Franche-Comté (CHU de Besançon et Dole)1
Le vaccin n'est pas fiable.
Plusieurs virus sont
responsables de la grippe.
Je laisse donc mes
anticorps faire leur boulot
J’ai a fait le choix de
ne plus me faire
vacciner car les
années où je l’ai
fait, j’ai été malade
1- La Vaccination Antigrippale des Professionnels de Santé – octobre 2007
https://drees.solidarites-sante.gouv.fr/IMG/pdf/Rapport_VAG.pdf
9Seasonal Flu vaccines’ efficacy is limited with high variations
and risk of mismatch
Seasonal Flu vaccine effectiveness in the US*
70%
60%
60%
56% 52%
52%
49% 48%
50% 47%
41%
Average 40% 40%
40%
41%
37%
30% Δ 50%
21%
20%
10% 19%
10%
0%
Source: CDC (Center for Disease Control) https://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm#table
10The solution and market expectation is a universal Influenza vaccine with
>70% efficacy against circulating and emerging Flu strains
The international Influenza community seeks for a vaccine with >70%
efficacy against all types of seasonal and pandemic Flu viruses
“To find a game changing, universal solution to all these challenges, […] the
goal is to identify novel, transformative concepts that will lead to development
of universal influenza vaccines offering […] protection of at least 70% against
moderate to severe disease caused by all strains of influenza A and B”
Source: https://gcgh.grandchallenges.org/challenge/ending-pandemic-threat-grand-challenge-universal-influenza-vaccine-development
11Agenda
• La grippe, une maladie dévastatrice, mais dont la composante
nosocomiale est sous-estimée
• Osivax, une société lyonnaise qui veut réinventer la vaccination contre
la grippe
12Osivax clinical-stage biotech company leverages its multi-patented
technology platform oligoDOM® to develop a diverse pipeline of vaccines
oligoDOM®, Osivax’s proprietary technology platform…
• Versatile technology to elicit powerful CD8 T-cell immunity
• Capitalizing on 10 years of R&D
• Protected by 3 patent families
...is developed in vaccines and cancer immunotherapies
Disease Reasearch PC Phase I Phase II Leader
Leading
Universal Flu 2019
program
Internal
Immuno-onoclogy
Confidential Big Pharma
Malaria (TBV1)
External
HPV2
1-TBV: Transmission Blocking Vaccine 2-HPV: Human Papillomavirus
13A seasoned leadership team leading a team 14 experts in vaccines
Management team Scientific Advisory Board
M. Alexandre Le Vert
CEO and Co-founder Prof Jeffrey Almond
Former VP Research and
External R&D at Sanofi-Pasteur
Dr Florence Nicolas
Chief Development Officer and Co- Dr Nathalie Garçon
founder CEO of BioAster
Former VP, Head of Global
Vaccine Centre […] at GSK
Dr Delphine Guyon-Gellin Biologicals
Chief Business Development
Officer
Prof Sir Andrew McMichael
Molecular Medicine &
Immunology
Dr Simonetta Viviani Oxford University
Medical Director (acting)
Prof Tim Mosmann
Dr Fergal Hill Director of the Human
Chief Scientific Officer (part-time) Immunology Center
University of Rochester, NY
and Co-founder
14oligoDOM® elicits powerful CD8 T-cell response against a carried antigen
oligoDOM® is fused genetically to an antigen …and stimulate the 3
to form a recombinant protein… arms of immunity
Antibody
Naked oligoDOM® The vaccine
Spontanous
antigen fused to the antigen
heptamerization Neutralizes the antigens
CD8 T-cell “cytotoxic”
Kills infected cells
• Versatile technology CD4 T-cell “helper”
• Excellent safety profile
Limited cellular • Developed in Flu, Malaria, HPV1
Highly immunogenic
immunogenicity • Protected by 2 patent families version of the antigen1
Potentiates Antibody
and CD8 T-cell responses
1-Multiple publications on oligoDOM® (OVX313) and its 1st generation-IMX313: http://www.osivax.com/publications.html
15OVX836, monovalent A-strain vaccine demonstrated safety and efficacy in
animal challenge models, and entered the phase I clinical stage in June 2018
Preclinical
Challenge
study1
•100% survival against multiple strains
•Synergy with seasonal vaccines2 ✓
efficacy
Challenge
study1
•Full protection against heterologous strain3
•Synergy with seasonal vaccines2 ✓
Preclinical
safety
GLP toxicology
study
Excellent safety and toxicology profile
✓
First in Human • Primary: Safety
Phase 1 (n=72 patients) • Secondary: NP specific immune response
Ongoing
1-Each POC in animal challenge model was repeated in different labs in Canada and France with >400 mice and >50 ferrets
2-OVX836 + seasonal vaccine > seasonal vaccine alone
3-with a different NP from the one in the vaccine
16OSIVAX developed a cost effective and scalable manufacturing process
Insertion of the Fermentation
gene of interest and expression of the
in DNA plasmid protein of interest OVX836 = the vaccine
NP OVX313
NP antigen
Single-step
purification
OligoDOM®
(OVX313)
• Stability >12 months1 at 5°C
• COGSWe have embarked into a 5 years clinical development plan that will lead to
the generation of a leading vaccine in the prevention of influenza
Today
2017 2018 2019 2020 2021 2022
Preclinical Phase Ib
Phase I 1 follow-on 2
1st generation Development
IND package
Ph IIa
A-strain 2
Immuno
Flu vaccine Ph IIa
Challenge 4a
test1
2nd generation Preclinical Development 3
A and B-strains Staged Ph. I/IIb real life 4b
Universal Flu
vaccine
OSIVAX inception (IMAXIO spinoff)
1-Human Challenge Study dependant on the funding by a governmental agency (e.g. BARDA, H2020) or foundation (e.g. BMGF)
18Remerciements à nos partenaires
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