Transcription of 에이비온주식회사 - kr.abionbio.com
1 Copyright 2014 ABION Inc. All Rights Reserved PerpetualPharmaceutical Pearl Provider2014. 2014 ABION Inc. All Rights Reserved ContentsI. II. - - - III. 3 Copyright 2014 ABION Inc. All Rights Reserved I. 2007 04 16 34 5 202 242 9 2 20 318 2013 20 ( ) 63 ( 6 , R&D 27 , CRO 13 , 5 , 10 , 2 ) 2007. 4 2009. 3 2009. 12 2010. 8 (INNO-BIZ) 2010. 9 ISO9001 2013. 1 2013. 2 IB 2013. 4 2013. 9 2013. 12LB IMM 2012. 12( ) 2011. 9 License-out 2014. 7 KONEX 2014. 6 4 Copyright 2014 ABION Inc. All Rights Reserved BusinessPartnersI. FinanceLegal & IPR&DCRO5 Copyright 2014 ABION Inc.
2 All Rights Reserved C R O 1 2 ( ) PACS RA QA TFTI. (R&D Center )(Abion CRO )(Abion Biomed )* , CRO, 6 Copyright 2014 ABION Inc. All Rights Reserved II. ABION (Carbiferon)- (2-in-1 siRNA )- (B12)7 Copyright 2014 ABION Inc. All Rights Reserved R&D Global Market Targeting Early License-out Business Model Perpetual Pharmaceutical Pearl Provider Target Specific New Bio Drug Companion Diagnostics Worldwide Open Innovation Patent FocusII. 8 Copyright 2014 ABION Inc. All Rights Reserved Pipeline Carbiferon/PEG-Carbiferon: 2016 License-out T16_426: siRNA CMC Data License-out OVC_CLD: Indication Candidate 201120122013201420152016 Type of Drug Multiple Sclerosis & Anti-virusCarbiferonCarbiferon-PegMicell eCarbiferon(Protein)OncologyT16_426siRNA OVC_CLDmAb-conjugated micelleSC_mCDmAb-ProteinSC_mT1 Bispecific Ab-conjugatedmicelle: License-outClinicalPre-ClinicalR&DClinic alPre-ClinicalR&DClinicalPre-ClinicalR&D Pre-ClinicalR&DPre-ClinicalR&DClinicalPr e-ClinicalR&DII.
3 9 Copyright 2014 ABION Inc. All Rights Reserved Interferon- (Carbiferon) For Multiple Sclerosis10 Copyright 2014 ABION Inc. All Rights Reserved Problems of Conventional IFN- drugs (Betaseron , Rebif , Avonex )Background of Technology11 Copyright 2014 ABION Inc. All Rights Reserved Conventional IFN- problems : Side Effects Side Effects of Conventional IFN- Drug Injection Site Reactions Flu-like Reactions; Depression; Headache; Fatigue Liver Test AbnormalitiesBackground of Technology12 Copyright 2014 ABION Inc. All Rights Reserved IFN- Mutein : Bio-better (Abion s Candidate Carbiferon, R27T) One/Two Additional Glycosylation from Conventional Interferon- 1a Creation of Low Immunogenicity by Minimal Amino Acid Change Creation of Prolonged Half Life Time by Increased Absorption Time Technology Highlights of Abion s Candidate13 Copyright 2014 ABION Inc.
4 All Rights Reserved Target Disease : Multiple Sclerosis (MS) Patient seconomicburdendecrementImprovedpatient` scomplianceImprovedtolerability(immunoge nicity)MarketAdvantageConclusion14 Copyright 2014 ABION Inc. All Rights Reserved PatentTitleCountryPatent DateApplication Interferon-Beta MuteinKorea , Switzerland, France, United Kingdom, Hungary, Ireland,Finland, Portugal, Italy, Spain, Portfolio15 Copyright 2014 ABION Inc. All Rights Reserved Analysis SWOTS trengthOpportunityThreatWeakness Superior Patent Portfolio Guaranteed Safety from Biobetter Improved Patient s Convenience Lower Cost Clinical Trial for Efficacy FDA Approval Follow-Up Development Limitation in Drug Modification Expanding MS Drug Market Patent Expiration of Original Drug Needs for Biobetter Price Competition Unbalance in Inter-National Approval Possibility of Superior New Drug Market Competition Barrier byOriginal BlockbusterSWOT16 Copyright 2014 ABION Inc.
5 All Rights Reserved 17 Copyright 2014 ABION Inc. All Rights Reserved ANTI-E6/E7 (2-IN-1) siRNA SENSITIZERIn HPV-related Cancers18 Copyright 2014 ABION Inc. All Rights Reserved Cervical Cancer: Medical Unmet Needs19 Copyright 2014 ABION Inc. All Rights Reserved Development of 2-in-1 siRNA CandidatesBackground of TechnologyDerivatives Production byChemical modifications:2 -O-Me modified nucleotides2 -F modified nucleotides20 Copyright 2014 ABION Inc. All Rights Reserved Development of 2-in-1 Candidates and siRNA Pool (SP)HITS creening LeadDerivativeCandidatesiRNAPool (SP)Anti E6/E7(2-in-1)siRNAHPV18 Type 10 Type siRNA Type 10 Type siRNA IPatent IIPatent III*COMPOSITION FOR TREATMENT OF CERVIX CANCER -Registered in South Korea-Under prosecution in USA*COMPOSITION FOR TREATMENT OF HPV RELATED CANCERS-Registered in South Korea-PCT*COMPOSITION FOR TREATMENT OF HPV RELATED CANCERS-Under prosecution in South Korea-PCT21 Copyright 2014 ABION Inc.
6 All Rights Reserved Power of 2-in-1 siRNA Combination with cisplatin and HPV18/16 type lead siRNA Combination with irradiation and HPV18/16 type lead siRNA Proof-of-concept and Mode of actionin combination therapy with 2-in-1 siRNA Synergism analysis in combination therapy with lead (2012 Apr 15;130(8):1925-36) -Submission Human papillomavirus E6/E7-specific siRNA potentiates the effect of radiotherapy for cervical cancer in vitroand in vivo (2012 Apr 15;130(8):1925-36) Combinationwith Cisplatin The synergistic therapeutic effect of cisplatin with Human Papillomavirus E6/E7 short interfering RNA on cervical cancer cell lines in vitro and in vivo 22 Copyright 2014 ABION Inc. All Rights Reserved Comparison with Conventional ( )Vaccine SmithKline Beecham Biologicals (Belgium)2JP2004-315433 ( )Pharmaceutical composition for preventing or treating papilloma virus-induced disease Containing antigenic protein of papillomavirus and cpg-oligodeoxynucleotide3US7956177 ( )dsRNA compositions and methods for treating HPV Pharmaceuticals, Inc.
7 (USA)4KR10-2009-0005011 ( )HPV16-based Papillomavirus vaccineTransgene (France)5EP2112157( )Long peptides of 22-45 amino acid residues that induce and/or enhance antigen specific immune responsesacademisch ziekenhuis leiden (Netherland)6KR10-2013-0040675 ( )BIFIDO BACTERIUM ADOLESENTIS SPM 1005-A HAVING ANTIVIRAL ACTIVITY FOR HUMAN PAPILLOMAVIRUS, AND COMPOSITION FOR PREVENTING OR CURING OF HUMAN PAPILLOMAVIRUS INFECTION COMPRISING BIFIDO BACTERIUM ADOLESENTIS SPM 1005-A OR CULTURED MATERIAL OF THE SAME SAHMYOOK UNIVERSITY (Korea)7US8258111 ( )Compositions and methods related to miRNA modulationof neovascularization or angiogenesisThe Johns Hopkins University ( ) There has been no report about siRNA therapeutics development in HPV-related cancers as combinational agent approach23 Copyright 2014 ABION Inc. All Rights Reserved Possessed Technology Status siRNAs are regulated as drugs : -Under FDA s Center for Drug Evaluation and Research [CDER] siRNAs are synthetic molecules (cGMP) Polymer basednanoparticle(non-viral vector): (Easy to commercialize)Easy Development `2 in 1 siRNA system`: simultaneously inhibit E6 and E7 oncogene Synergistic therapeutic effects with chemo-/radio-therapy Play a role as Sensitizer Application inHPV-related cancer research(Anal cancer, Head and Neck cancer, Oral cancer, Penile cancer, Lung cancer, etc.)
8 2-in-1 siRNA Chemical modification of nucleotides by 2'-OMe: a increase in serum stability Formulation optimization -Polymer based delivery systemMaximizing Stability Chemical modification of nucleotides by 2'-OMe: a decrease in off-target effect siRNAPOOL technology Polymer based nanoparticle for enhanced drug deliveryReduced ToxicityIncreased EfficacyAnti-E6/E7 (2-in-1) siRNAT herapeuticsOriginality of 2-in-1 siRNA therapeutics24 Copyright 2014 ABION Inc. All Rights Reserved Patent PositionPatentTitleCountryDate of ApplicationApplication PatentPatent (Applied/Approval)1stPatentCOMPOSITION FOR TREATMENT OF CERVIX CANCER Republic of Korea 2006. 11. 05. 0112/5133372ndPatentCOMPOSITION FOR TREATMENT OF HPV RELATED CANCERS Republic of Korea 2010. 01. FOR TREATMENT OF HPV RELATED CANCERS Republic of Korea 2014 ABION Inc.
9 All Rights Reserved 26 Copyright 2014 ABION Inc. All Rights Reserved B12 Antibody DrugFor Ovarian Cancer27 Copyright 2014 ABION Inc. All Rights Reserved (B12) B12 (CD3, CD4) : : 2012 160 , 2013 187 (CARG ) : ( , ) 28 Copyright 2014 ABION Inc. All Rights Reserved Anti-Claudin ADC Therapeutic Anti-CLDN3/4 mAbAntigen DesignAntibody ScreeningIn vitro AssayIn vivo AssayPolymer with Sensor Binding LinkerBortezomib,Docetaxel,Oxaloplatin, Conjugated PolymerDrug Conjugated MicelleActive Targeting MicelleAnti-CLDN3/4 Antibody or Antibody FragmentAntibody Drug Conjugated Micelle(Co-development with JPN Company)300~500 Drug moleculesBortezomib29 Copyright 2014 ABION Inc.
10 All Rights Reserved Group TRL TargetIndicationScreening / Kohleisen Group (NIH, US) Hit 1 CLDN3 Pan-Carcinoma Affinity CLDN4 CLDN 1PJ Morin Group (NIH, US) 1 CLDN3, 4 Pan-CarcinamaAffinity Smith MD Group (Brescia Univ. Italy)Hit 1 CLDN3 Ovarian Cancer10-8 Uterine CancerAndo Group(Kyowa Hakko Kirin)Candidate 2 CLDN4 Pancreatic CarcinomaCytotoxicity Ovarian CancerStepheen BH Group (Univ. of California)Hit 1 CLDN3 Ovarian CancerCPE immunogenicityJanet A. Sawicki GroupHit 1 CLDN3 OvarianCancerCLDN3siRNA /Proofof ConceptKenji Group(ForerunnerPharma research Co., Japan)Hit 1 CLDN3 Pan-CarcinamaAffinity ABION 2 CLDN3 Ovarian CancerPan-CarcinomaCompanionDiagnostics / CLDN430 Copyright 2014 ABION Inc. All Rights Reserved III.