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Alaxia
- 1. Alaxia A company dedicatedto orphan drugs Meveol program supported by ALAXIA SAS, France
- 2. Location and PrimaryFocus • Incorporated in 2008, ALAXIA is a private biotech company based in Lyon, France. • Main Focus: Development of medicinal products targeting respiratory diseases, Products exiting our Peroxidase plate-form.
- 3. Organizational Structure Board Dr Ernest NUSSBAUMER President Philippe BORDEAU CEO Dr Jean Paul PERRAUDIN CSO SCIENTIFIC COMMITEE (G Bellon, P Diot, S Elborn,… ) Annie Claude BENICHOU, MD Medical Advisor Dr Maria CHAVARINO PharmD Head Regulatory Affairs Meveol dvpt program Pilot Dr Emmanuelle GEORGI Dr Sandrine PERROTTO Dr Naima BENABDELLAH PhD PharmD Philippe NUSSBAUMER MD External relations (NPO,…) R&D Lab Pharmaceutical Affairs Medical Affairs External advisers Dr Philippe DAVIOUD (Pharm), Dr Behrouz KASSAI (Med),, Dr Annie Claude Benichou (MD), Dr Joël Guillemain (Tox), Dr Yves Dumas (Reg), ERA ( FDA)
- 4. Intellectuel Property andCorporate Assets • Intellectual Property • 6 Patents • Patents on formulation • Patents on application (Infectious disease, CF, COPD) • Patents on active ingredients manufacturing • 2 Brands • Orphan medicinal product designations (2009) in regards to our novel compound Meveol for Cystic Fibrosis • EU/3/09/654 • US #09-2946 • Expertise • Plate-form on Peroxidase • AMP (Antimicrobial Proteins)
- 5. Executive Summary ofwhy to Partner with Alaxia • Alaxia prepare phase 1 for Meveol • Meveol is safe (Safety pharm, gentox,… NO TOX) • Meveol can be breathed for respiratory diseases or ingested for gastric • Secured U.S. & E.U orphan drug designation and fully committed to molecule, regulatory approval and launch • Alaxia seeking funding/partnership to expedite clinical program, regulatory filings, and co-marketing • Other products under development
- 6. Drug Pipeline Strategy Pipelinestrategy 1) Develop Meveol® as orphan drug for Cystic Fibrosis ▪ ~100,000 patients affected by pulmonary infections 2) Strengthen other programs currently under discovery, dvpt, … 3) License products, program ▪ URTI (Sore throat, sinusitis), LRTI ▪ COPD
- 7. Alaxia’s Pipeline Application Discovery Preclinic PhaseI PhaseII PhaseIII To Patient Cystic MEVEOL Fibrosis ALX-08 COPD ALX-10 Lung Cancer Gastric ALX-G01 Cancer Crohn‘s ALX-G02 disease ALX-06 Influenza ALX-09 Tuberculosis Oral & Nose ATC-01 Care
- 8. MEVE L Cathy, Jacky Pilou, Cezar www.alaxia-pharma.eu ALAXIA SAS 3-11 Rue Perlerie F- 69120 Vaulx en Velin Phone : +33.(0)4.72.81.09.26 Fax : +33.(0)4.78.41.17.79 Email : contact@bioalaxia.eu Program supported by www.meveol.eu
- 9. Meveol : Alaxia’sFirst Drug in Development • Attributes of Meveol for Cystic Fibrosis • 1st product exiting in our peroxidase plateform • Antimicrobial, wide spectrum, – Pseudomonas Aeruginosa , Burkholderia cepacia, MRSA, Mycobacterium abscessus… • Mechanism of action: 1) Delivers the missing antimicrobial compound,( OSCN-), directly on the lung epithelium 2) Disrupts established biofilm (Lactoferrin) • No antibiotic resistance risk • Very low toxicity • Inhalation use • Strong scientific background in respiratory – Cystic Fibrosis – URTI, LRTI,…
- 10. Recent Articles ofInterest “Recent Discovery“ done by Banfi, Conner, Childers, Rogan * on innate lung defenses • Childers M, Eckel G, Himmel A, Caldwell J. A new model of cystic fibrosis pathology: lack of transport of glutathione and its thiocyanate conjugates. Med Hypotheses. 2007;68(1):101-12. SCN- doesn’t cross CFTR • Moskwa P, Lorentzen D, Excoffon KJ, Zabner J, McCray PB, Nauseef WM, Dupuy C, Bánfi B. A novel host defense system of airways is defective in cystic fibrosis. Am J Respir Crit Care Med. 2007;175(2):174-83 OSCN- natural antimicrobial compound miss in CF • Conner GE, Wijkstrom-Frei C, Randell SH, Fernandez VE, Salathe M. The lactoperoxidase system links anion transport to host defense in cystic fibrosis. FEBS Lett. 2007;581(2):271-8 Lactoperoxidase system innate host defense can’t work in CF • Rogan MP, Taggart CC, Greene CM, Murphy PG, O’Neil SJ, McElvaney NG . Loss of microbicidal activity and increased formation of biofilm due to decreased lactoferrin activity in patients with cystic fibrosis. J. Infec. Dis. 2004; 190:1245-53 Lactoferrin activity is decreased in CF Shows high interest of OSCN- + Lactoferrin (Meveol® API) * not linked researchers team
- 11. CFTR, also SCN-channel (an halogen channel) Childers et al, 2007 SCN- alone is not able to reach airway peroxidase. H2O2 generator, Duox, are inhibited by pyocyanin, Thus OSCN- cannot be produced locally Note : Level of SCN- in CF patients saliva is statistically impaired compared to healthy non smokers or healthy smokers, Minarowski, 2008
- 12. Cystic Fibrosis Overview Airways,Peroxidases and OSCN- Rada et al, 2008 Fischer, 2009 Childers et al, 2007
- 13. MEVEOL® Meveol® (OSCN-/Lactoferrin) works by following mechanisms - Disrupts microbial biofilm (Lactoferrin) OSCN- Lactoferrin - Kills bacteria (OSCN-/Lactoferrin) - Targets to compensate and to restart airway peroxidase system (OSCN-) using endogenous H2O2 Biofilm OSCN- Airway peroxidase Pseudomonas CFTR H2O2 O2 Respiratory tract SCN- DUOX Airway epithelium
- 14. Meveol® Some targets(Non exhaustive list) Bacteria • Acinetobacter species • Shigella sonnei • Aeromonas hydrophila • Staphylococcus aureus, Staph. Aerogenes (+Gram) • Bacillus brevis, Bacillus cereus (+Gram) • Streptococcus agalactiae, Strept. Faecalis (+Gram) • Bacillus megaterium, Bacillus subtilis (+Gram) • Streptococcus mutans (+Gram) • Burkholderia cepacia • Wolinella recta • Campylobacter jejuni • Xanthomonas campestris • Clostridium perfringens (+Gram) • Yersinia enterocolitica • Capnocytophaga ochracea • Corynebacterium xerosis (+Gram) • Enterobacter cloacae • Escherichia coli • Haemophilus influenzae • Helicobacter Pylori Virus • Klebsiella oxytoca , Klebsiella pneumoniae • Herpes simplex virus • Legionella • Immunodeficient virus • Listeria monocytogenes (+Gram) • Respiratory syncytial virus • Mycobacterium abscessus, smegmatis, tuberculosis • Influenza virus • Neisseria species • Pseudomonas aeruginosa • Salmonella species Tested by Alaxia or Alaxia’s partners
- 15. Antibacterial activity vs.Pseudomonas aeruginosa Active compounds at T0
- 16. Antibacterial activity vs.Burkholderia cepacia Active compounds at T0
- 17. Antibacterial activity vs.MRSA Active compounds at T0
- 18. Recent Trials: Mycobacteriumabscessus Meveol vs Mycobacterium abscessus Meveol at T0 only 12 10 8 log CFU/ml Control 6 Meveol 4 2 0 0 5 10 15 20 25 30 35 40 45 Contact Time (Hours) Active compounds at T0 In growth media solution
- 19. Recent Trials: MEVEOL® •In Vivo Preliminary results • Species : Mice • Breed C57Bl6 • Infection by mucoid Pseudomonas aeruginosa (isolated from Cystic Fibrosis patients) • Meveol treatment started 24 hours after infection • Second treatment 48 hours after infection • Sacrifice 72 hours after infection Protocol agreed by CER Ethic committee on animal welfare
- 20. In Vivo efficacy 5,0 4,5 Mice lung 72h after infection by 106 CFU mucoid pseudomonas aeruginosa 4,0 3,5 Lung bacteria (log CFU/g) 3,0 2,5 ≠1,6 log 2,0 1,5 1,0 N=9 Average : 3,1 N=12 0,5 Average : 1,5 SD : 0.4 SD : 0.5 0,0 Infected control Treated 2 trials, same efficacy acheived
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- 22. Unique Characteristics ofCompany • Compounds missing in Cystic Fibrosis patients (Meveol) • Intellectual Protection – Own Patents & Brands (Alaxia®, Meveol®) – Internal R&D peroxidase plateform • Orphan drug designation www.alaxia-pharma.eu – EU/3/09/654 & US 09-2946 • Strong scientific background – Recent US discovery (Banfi, Childers, Conner, Rogan, Rada) – Proof of concept validation (Vitro, Vivo) – Biofilm destruction, Eradication of bacteria targeted (Dartmouth Medical College) • Unique know how – Hypothiocyanite (OSCN-), Lactoferrin, Peroxidase approach • A new compound with No Tox (Safety pharm, Gentox,…) • Strong Scientific Committee (KOL) • Interesting Pipeline • License/formulations/program available