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Corporate presentation, February 2013

Anti microbial peptides for the fight against multi drug resistant bacteria. Corporate presentation, February 2013. Summary – Adenium Biotech. New biotech company - Spin out of Novozymes AMP program - Strong scientific advisory board and VC syndicate

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Corporate presentation, February 2013

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  1. Anti microbial peptides for the fight against multi drug resistant bacteria Corporate presentation, February 2013

  2. Summary – Adenium Biotech New biotech company - Spin out of Novozymes AMP program - Strong scientific advisory board and VC syndicate Target XDR Gram negative bacteria - Gram-negative platform with novel mode of action - No novel bactericidal Gram-neg antibiotics in clinical development Adenium Biotech pre-clinical studies - In vivo efficacy against XDR Klebsiella, Pseudomonas, Acinetobacter and E. coli in several animal models - Wide therapeutic window in mice and pigs - Lead optimization for selection of lead product candidate in 2013 Strong intellectual property position 2

  3. Adenium Biotech ApS • Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet, ARTS Biologics - Søren Neve, PhD, project dir, ex Lundbeck, Novozymes • Investors: - Novo Seeds - Sunstone Capital • Board of Directors: - Khalid Islam, PhD, ex Arpida, chairman - Anker Lundmose, MD, ex Novo Nordisk, OSI Pharmaceuticals - Andreas Segerros, MSc, MBA, Sunstone Capital - Stephan Christgau, PhD, Novo Seeds - Casper Tind Hansen, MSc, Novo Ventures - Ejner Bech Jensen, MSc, VP R&D Novozymes A/S • Scientific advisory board: - Prof Brad Spellberg, US- Prof avid Livermore, UK- Dr Bruce Montgomery, US- Dr Frank Fildes, UK - Prof Niels Høiby, Denmark 3

  4. Arenicin selection process > 500 organisms screened for antimicrobial activity 1500 hits but only 10 variants selected Several G+ but only one G- identified ! NZ17074 Lead First Hit Second variant library (~90.000 variants) Variant library generation (~250.000 variants) ~40 AMP’s identified 4

  5. Unique MoA and broad spectrum Gram-negative activity • Arenicin has dual mode of action and is bactericidal • Bacterial membrane penetration • Protein synthesis inhibition • No haemolytic or cytotoxic activity in mammalian cells • Broad spectrum activities against a wide range of XDR Gram negative pathogens • Wide therapeutic window. 50 – 200 fold difference between effective dose and MTD in vivo • Very low spontaneous mutational frequency and resistance • 21 AA peptide synthesized by standard solid phase synthesis 5

  6. Arenicin-3 and the cell membrane -MoA Extracellular ATP after 10 min Fold change A. E. coli exposed for 30 min to wt and stained with TRITC. Treatment with wt results in influx of TRITC into the E. coli • B.E. coli exposed for 30 min with TRITC labelled wt. Clusters ofwt were localized in the bacterial membrane At OD600 =0.4 E.coli cells were exposed to 32ug/ml Arenicin, 64ug/ml Fosfomycin and 16ug/ml Polymycin B. Even at very high concentration of Arenicin-3, no dramatic morphological changes of the cells were observed. x MIC Arenicin-3 (Ar), colistin (col), and piperacillin (pip) inducedrelease of ATP from E. coli. Exponential cells were incubated with drug for 10 minutes and ATP measured. y-axis is fold change relative to untreated (0xmic) and x-axis is fold MIC applied. 6

  7. Low hemolytic and low cytotoxic activity wt 7

  8. Efficacy compared to current treatment options. MIC90 determinations 8

  9. Spontaneous mutational frequency 9

  10. Klebsiella/Pseudomonas/Acinetobacter bioload reduction Mouse lunginfection Mouse strain : CD-1 Hours 0 2 4 6 8 24 Treatment Evaluation of CFU in lung Inoculum Bacteria ~108

  11. Dose response in the UTI mouse model ED50 ~1.5 mg/kg in urine and ~ 1.8 mg/kg in the bladder Mouse urinary tract infection Mouse strain : OF-1 Days -4 0 1 3 5% glucose in drinking water Inoculum Treatment BID Evaluation of CFU in Urine, Bladder And Kidney E.coli ~108 11

  12. Toxicological overview after 7 days of daily dosing in mice 12

  13. Comparison of kinetics in pigsand mice 13

  14. Development program • Selection of lead product candidate in Q3 2013 • CMC and preclinical tox initiated in Q4 2013 • First human dose in Q4 2014 • Phase IIa initiated in 2015 • Initial registration in cUTI • Main indication HAP/VAP 14

  15. External activities and cost for development of Arenicin in cUTI 5 3 9 3 12 6 3 3 12 18 6 15

  16. Milestone plan In vivo efficacy demonstrated against Pseudomonas, Acinetobacter and Klebsiella in pneumonia Completed Three leads identified for lead optimization Completed Bronchioalveolar lavage study April 2013 Mode of action May 2013 ED 50 in pneumonia Sept 2013 PK/PD in UTI Oct 2013 Lead candidate selection Oct 2013 Pre-clinical tox/safety completed Dec 2014 IND filing Q1 2015 Phase I SAD/MAD study completed Q1 2016 Phase IIa completed Q1 2017 16

  17. Intellectual property Broad IP portfolio with composition of matter and method of use patents. Future patents on specific variants and formulations possible. 17

  18. Key Value Drivers for Investment Broad spectrum XDR Gram-negative first in class drug with unique MoA Significantly increased interest in anti-infectives area with GAIN Act/LPAD introduction No new MoA programs in clinical development Good safety and tox properties and solid in vivoPoC package Phase IIa data package to be established for USD 15 mio Experienced team to execute development plan 18

  19. Contact details Dr Peter Nordkild Mobile: + 45 25 47 16 46 Email: pno@adeniumbiotech.com Website: www. Adeniumbiotech.com 19

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