AiCuris: 10 years of successful R&D in anti-infective therapy BIO Europe Cologne, Germany; 08 November 2016
AiCuris: The Powerhouse for Anti-Infectives “Committed to making the difference”
AiCuris at a Glance The Powerhouse for Anti-Infectives Foundation Spin-out from Bayer’s Antiinfective research in March 2006. Built up with 21 Bayer experts – today 55 employees Approach Development of resistance-breaking antiviral & antibacterial agents with new mode-of-actions and/or from new chemical classes Projects / Products - addressing high medical need Antivirals (HCMV, HSV, HBV, Adenovirus) and Hospital Antibiotics Lead candidate Letermovir (prophylaxis and treatment of HCMV) licensed to Merck & Co (MSD), currently in clinical Phase 3 3 AiCuris - BioEurope 2016
Achievements in Research & Development AiCuris’ research activities in Virology and Bacteriology resulted in several new development candidates AiCuris’ development activities Currently 5 projects in Phase 1 2 compounds achieved proof of concept and successfully completed dose-range-finding in Phase 2 1 compound reached Phase 3 clinical testing (cooperation with MSD) 4 AiCuris - BioEurope 2016
AiCuris – R&D Pipeline Indication Program Discovery Preclinical Phase I Phase II Phase III HCMV Letermovir (AIC246) Human cytomegalovirus [Licensed to Merck&Co (MSD)] AIC476 AIC387 AIC813 [Licensed to Merck&Co (MSD)] HSV Pritelivir (AIC316), oral Herpes simplex virus Pritelivir (AIC316), topical Autoimmune diseases AIC284 HBV AIC649 Hepatitis B virus Research Adenovirus Research Hospital antibiotic AIC499 [supported by IMI] Research Research 5 AiCuris - BioEurope 2016
Gram-negative Resistance Breaker (AIC499) Superior Drug with Blockbuster Potential USPs Hospital-treated Gram-negative Indication bacteria, expected Multidrug resistant (MDR) Gram-negative infections market volume caused by a broad range of bacterial species incl. (2021) $3.8B P. aeruginosa and Enterobacteriaceae No approved drug with comparable Mode of action MDR coverage so Resistance-breaking β -lactam for broad empiric use in combination far antibiotic with β -lactamase inhibitor (BLI) Premium pricing due to high unmet medical needs in Status of development Advanced Preclinical development life-threatening situations Next events Start clinical Phase 1 expected end 2016 6 AiCuris - BioEurope 2016
AIC499 profile – Pathogen Coverage Enterobac- ESBL AmpC KPC OXA-48 NDM P. aerugi- P. aerugi- Acineto- A. bau- teriaceae strains strains strains strains strains nosa wt nosa MDR bacter wt mannii wt strains strains strains MDR strains meropenem imipenem piperacillin + tazobactam ceftazidime ceftazidime + avibactam aztreonam aztreonam + avibactam AIC499 AIC499 + tazobactam excellent coverage (>90%) good coverage (70% - 89%) partial coverage (30% - 69%) no coverage (<29%) BLI combination data was not determined AIC499 + BLI allows to treat a vast proportion of infections caused by Gram- negative wild-type and MDR pathogens 7 AiCuris - BioEurope 2016
Pritelivir (AIC316) A Perfect Protection against Herpes Simplex Virus Indication: HSV infections in immune suppressed patients (“last resort”), treatment and suppression of recurrent genital and labial herpes USPs Mode of action: Inhibition of HSV helicase-primase Novel mode of action Protection of uninfected cells Status of development: In preparation for clinical Phase 2 for “Last Resort” In preparation for clinical Phase 2 for “Labial herpes” Next events Start Phase 2 for “Last Resort” in immunocompromised patients Start Phase 2 for labial herpes 8 AiCuris - BioEurope 2016
Pritelivir A Perfect Protection Against HSV HSV Cells protected for >24 h due to long Present drugs do not cover sufficient exposure for continuous control of HSV half-life Viral enzyme (TK) needs to be present for no activation required activation of nucleosides Perfect protection No protection of uninfected cells Highly effective suppression of recurrent episodes, shedding and transmission 9 AiCuris - BioEurope 2016
Pritelivir - AIC316-01-II-01 Phase 2 Pritelivir vs. Valtrex™ Shedding rate Lesion rate 6 4.5 5.4 4 5.2 3.9 4 5 Shedding rate (%) 3.5 Lesion rate (%) 4 3 *** *** *** *** 2.5 3 2.4 1.9 2 1.7 2 1.5 1.1 1 1 0.5 0 0 Pritelivir Valacyclovir Pritelivir Valacyclovir Pritelivir Valacyclovir Pritelivir Valacyclovir ITT PP *** p<0.0001 Not shown: log HSV DNA, shedding AUC, as well as number of subjects reporting pain was significantly lower under pritelivir than under valacyclovir Pritelivir superior to valacyclovir in primary and secondary endpoints 10 AiCuris - BioEurope 2016
Letermovir (AIC246) New Treatment Approach against HCMV Indication HCMV infections in cases of immune incompetency, deficiency or immunosuppressed patients (e.g. transplant patients) USPs Mode of action Novel mechanism Antiviral drug, inhibition of HCMV viral terminase of action Good oral Status of development bioavailability and lack of toxicity Met primary endpoint in Phase 3 efficacy / safety study for prevention of HCMV infection in bone-marrow-transplant recipients (conducted by Merck & Co.) Orphan drug status in EU and the US, FDA Fast Track Designation 11 AiCuris - BioEurope 2016
Partnering Track Record Breakthrough Alliance Award 2013 by Deloitte Recap AiCuris and Merck & Co, USA Enter Exclusive Worldwide License Agreement for Investigational Portfolio Targeting Human Cytomegalovirus Asset The deal structure Highlights Letermovir, first-in-class Upfront payment €110 m Biggest licensing deal small molecule of a German biotech Milestone payments candidate against the company €332.5 m Human Cytomegalovirus Awarded „Deal of the Royalties on worldwide (HCMV) plus back-up Year“ 2013 with sales project prestigious Deloitte Option to co-promote in Recap Breakthrough selected countries Alliance Award 12 AiCuris - BioEurope 2016
Summary – 10 years of AiCuris A Company with Proven Track Record in R&D Scientists and experts in all Global network of experts, focus research fields and for all partners and service providers pre-clinical and clinical development activities Proven track record as PoC In addition to in-house R&D, company focused scouting activities towards identification of: Current pipeline comprises advanced projects originating from New interesting targets/MoAs for own in-house research antivirals and antibacterials Multiple new research and Potential joint development partners development projects since and in-licensing opportunities foundation in 2006 Opportunities to expand our pipeline and business The Powerhouse for Anti-Infectives 13 AiCuris - BioEurope 2016
AiCuris: 10 years of successful R&D in anti-infective therapy BIO Europe Cologne, Germany; 08 November 2016
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