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Immunotherapy for TB


RUTI2017 TBVI SymposiumLes Diablerets Switzerland Pere Joan CardonaRATIONALE DYNAMIC HYPHOTESISCardona PJ Front Microbiol 2016 Sep287 1536 ReviewMECHANISM OF ACTION Cardona PJ Front Microbiol 2016 Se

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Document on Subject : "Immunotherapy for TB"— Transcript:

1 RUTI  Immunotherapy for TB 2017 TBVI
RUTI  Immunotherapy for TB 2017 TBVI Symposium Les Diablerets , Switzerland Pere Joan Cardona RATIONALE: DYNAMIC HYPHOTESIS Cardona PJ. Front Microbiol , 2016 Sep 28;7: 1536. Review MECHANISM OF ACTION Cardona PJ. Front Microbiol , 2016 Sep 28;7: 1536. Review RUTI  • RUTI  is a non - live vaccine which has be

2 en designed to be administered therapeu
en designed to be administered therapeutically in combination with chemotherapy. • RUTI  is based on an induction of a polyantigenic cellular response against non - replicating bacilli. • RUTI  is a DS liposome suspension with a charge excipient. It is presented as a dry powder for reconstitution. • The RUTI  ’

3 s DS is based on cell wall fragments of
s DS is based on cell wall fragments of Mycobacterium tuberculosis which has been grown under stress conditions. • RUTI  vaccine is administrated subcutaneously in a single dose . • RUTI  vaccine is stable at 5C for more than 7 years . RUTI  DESCRIPTION RUTI  is entirely manufactured in Archivel Farma S.L.

4 facilities. The aim of RUTI treatme
facilities. The aim of RUTI treatment as an immunotherapy is to reduce the exposure to the antibiotic treatment and to increase the current treatment efficacy. THE AIM 7 Privileged & Confidential Archivel Farma Archivel Farma Archivel Farma Archivel Farma Archivel Farma Archivel Far Active TB Latent TB Infection Summa

5 ry of preclinical data • Therapeutics
ry of preclinical data • Therapeutics: in combination with short term chemotherapy:  In mice: RUTI avoids reactivation of infection after chemotherapy further reducing bacterial counts by TWO orders of magnitude  In guinea pig: RUTI reduces bacterial load after short term chemotherapy by ONE order of magnitude  In

6 goats: RUTI reduces pulmonary lymph nod
goats: RUTI reduces pulmonary lymph node pathology as compared with short term chemotherapy treatment or control  In minipigs: RUTI reduces the ratio of new vs old lesions when compared with short term chemotherapy alone • Prophylaxis: in guinea pigs and mice immunization prior to low dose challenge results in survival r

7 ates comparable to those of BCG • The
ates comparable to those of BCG • Therapeutics: as stand alone , in mice with low dose challenge RUTI prevents progression to active TB when given shortly after the challenge MDR - TB Drug susceptibleTB LTBI RUTI  THERAPEUTIC INDICATIONS Cardona PJ. Front Microbiol , 2016 Sep 28;7: 1536. Review Phase I LTBI phase II Targ

8 et population Healthy Latent TB infecti
et population Healthy Latent TB infection Period 2006 - 2008 2010 - 2012 Location site Badalona ( Spain ) South Africa Evaluated subjects 24 (4 patients / group ) 48HIV+ ; 48HIV - (12 patients / group ) Route Subcutaneous Subcutaneous Vaccinations number 2 shots 2 shots Doses 5, 25, 100 and 200 ug /dose RUTI / placebo 5, 2

9 5, 50 ug / dose RUTI / placebo Evalua
5, 50 ug / dose RUTI / placebo Evaluated items Safety and Immunological response Safety, tolerability and Immunological response Conclusions The safety of the vaccine has been demonstrated in healthy volunteers, and RUTI has also shown to trigger a specific response against Mtb antigens . Reasonable tolerability profile of RUT

10 I and a good polyantigenic response in
I and a good polyantigenic response in HIV - and HIV + subjects . A single vaccination would be sufficient to significantly reduce the incidence of TB after short term chemotherapy . RUTI  CLINICAL DATA RUTI  for MDR - TB Objectives : 1. To evaluate i ) the safety and ii ) the immunogenicity of the novel anti - TB vaccine RU

11 TI ( 25 g FCMtb ) in patients with MD
TI ( 25 g FCMtb ) in patients with MDR - TB favourably responding to second - line, standard MDR - TB treatment . 2. To explore the efficacy as the reduction of bacillary load in the sputum of the novel anti - TB vaccine RUTI ( 25 g) in patients with MDR - TB favourably responding to second - line, standard TB treatment . Curr

12 ently the MDR - TB CT is under submis
ently the MDR - TB CT is under submission in the Netherlands and close to be submitted in Romania. PHASE IIa MDR - TB CT Double - Blind, Randomized, Placebo - Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI Therapeutic Vaccination in Patients with MDR - TB after successful intensive

13 - phase treatment . PHASE IIa MDR - TB
- phase treatment . PHASE IIa MDR - TB DESIGN RUTI  COLLABORATIONS /TEAM With thanks to : Prof. Pere - Joan Cardona and Dr. Cristina Vilaplana. Unitat de Tuberculosis Experimental (UTE). Prof. Helen Fletcher & Satria Prabowo Prof . T . Van der Werf & M . Groeschel Dr. Simon Clark Archivel Farma’s TEAM Clinical and Deve