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Buffalo Biolabs (BBL) CRO capabilities, March 2014
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Buffalo Biolabs (BBL) CRO capabilities, March 2014

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Buffalo Biolabs (BBL) is a science-intensive Biotech company conducting preclinical contract research in a boutique fashion while solving intricate scientific problems, primarily in the field of …

Buffalo Biolabs (BBL) is a science-intensive Biotech company conducting preclinical contract research in a boutique fashion while solving intricate scientific problems, primarily in the field of cancer treatment, diagnostics and prevention; additional focus – infectious diseases.

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  • 1.   Contract  Research  Capabilities     Bridging  the  gap  in  biotech           73  High  St.    Buffalo,  NY  14203   pgrifAin@buffalobiolabs.com   (716)849-­‐6810  
  • 2. 2 Buffalo  Biolabs  (BBL)  Mission   ü Address  the  demand  for  early  stage  discovery  that  bridges  the  gap   between  Academia  and  Big  Pharma   ü Provide  clients  with  preclinical  data  to  drive  product  development   and  support  fundraising  efforts  from  proof  of  concept  to  IND     PROFILE  Science-­‐intensive  Biotech  company  conduc4ng  contract  research  in  a   bou4que  fashion  while  solving  intricate  scien4fic  problems,  primarily  in  the  field  of   cancer  treatment,  diagnos4cs  and  preven4on;  addi$onal  focus  –  infec$ous  disease.   EXPERTISE  Highly  educated,  cohesive  research  team  of  31  employees  including  14   Ph.D’s  with  exper4se  in  target/drug  discovery  and  preclinical  valida4on.    Over  1,000   years  of  combined  experience  in  academia  &  biotech.     INCEPTION  Integra4on  of  veteran  research  teams  from  Cleveland  BioLabs,  Inc.  (CBLI)   and  Roswell  Park  Cancer  Ins4tute  (RPCI).  Jointly,  these  teams  have  brought  several   drug  candidates  from  hypothesis  to  clinical  trials.     CUSTOMERS  RPCI,  CBLI,  other  local  Western  New  York  and  East  Coast  biotech   companies  (Incuron,  Tar4s,  Everon,  Panacela  Labs,  Felicitex,  etc.)  
  • 3. 3 BBL  Contract  Types   ü Fully  outsourced  research  needs   Broad  set  of  goals,  ini$ally  non-­‐determinis$c,  shi8ing  scope     ü Problem  solving   Applying  collec$ve  exper$se  towards  a  single  issue     ü Proof  of  Concept   Narrow  goals,  clearly  desired  outcomes     ü Streamlined,  long  term  capability  extension   Ideal  for  clients  that  do  not  operate  full-­‐fledged  research  facili$es  or  need   augmenta$on  of  their  efforts  with  proven  exper$se.     ü Project/Vendor  Management   Help  clients  manage  disparate  research  segments,  combined  from  BBL  and   external  vendors  including  Shared  Resources  of  Roswell  Park.  
  • 4. 4 Unique  Advantages   ü Freeing  seemingly  “stuck”  projects     Sophisticated  animal  models  at  industrial  scale  –  statistical  signi6icance  of   border-­‐line  effects     Integrated  approach  –  combine  modern  molecular,  cellular,  tissue  and   organism-­‐level  methodologies       ü Access  to  array  of  exceptional  facilities  of  Roswell  Park  Cancer   Institute,  close  collaborator  of  BBL  Research   Genomics,  microarrays,  HTS,  FACS,  TMA,  collection  of  primary  tumors,  access   to  clinical  samples  http://www.roswellpark.edu/shared-resources     ü Positioning  project  for  investment/funding  decision   Equipped  to  handle  complex  PoC  efforts   Established  track-­‐record  of  bringing  new  drug  candidates  from  early  discovery   to  IND     ü State-­‐of-­‐the-­‐art  core  facilities   Sophisticated  equipment  and  methodology   Combining  academic  depth  with  industrial  power  and  experience  
  • 5.          BBL  Labs              Corporate  Customers          BBL  Cores    Academic  partners   Histology Core Animal Core Chemistry and Bioanalytics Immunology Lab Preclinical Lab Validation Lab Cell Biology Lab Microbiology Lab RPCI SBMRI Services  &  Support   Applied  Research   CBLI Incuron Felicitex Everon Research/Service  Contracts   5   BBL  Contract  Research   Research  Collaborators   …
  • 6. 6   Examples  of  Research  and   Service  Activities   Customer:  CBLI   R&D  tasks:     Establish  an4cancer  efficacy  of  EntolimodTM  (protein-­‐based  drug  candidate)  in   preclinical  models   Service  tasks:     Bioanaly4cal  support  of  EntolimodTM  clinical  trials     Customer:  Incuron,  LLC   R&D  tasks:     Assess  in  vitro  and  in  vivo  effects  of  combining  CBL0137  (small  molecule  drug)  with   other  an4cancer  drugs   Service  tasks:     PK/PD  analysis  in  support  of  CBL0137  clinical  trials   CBLI Histology Core Animal Core Preclinical Lab RPCI Incuron Histology Core Animal Core Validation Lab RPCI Chemistry and Bioanalytics Chemistry and Bioanalytics
  • 7. 7   Research  Capabilities •  extensive  experience  in  mechanis4c  and  efficacy  studies  in  a  variety  of   in  vitro  and  in  vivo  models   •  iden4fica4on  &  valida4on  of  molecular/cellular  PD  biomarkers   •  establish  therapeu4c    window,  assess  impact  of  regimen,  and   evaluate  routes  of  administra4on   •  access  to  a  variety  of  mouse  models  (incl.  gene  KO,  chimera,  etc.)   Preclinical Lab Validation Lab Cell Biology Lab •  iden4fica4on,  targe4ng,    and  valida4on  of  novel  pharmacological   targets  and  drugs   •  development  of  cell-­‐based  assays  for  targeted  drug  screening   •  bio-­‐potency  and  target  specificity  of  drug  candidates  in  mul4ple    cell   lines   •  efficacy  vs.  dose-­‐limi4ng  toxicity,  drug  combina4ons  in  animal  models   •  assessment  of  cellular  drug  response   •  cul4va4on,  frac4ona4on  and  iden4fica4on  of    drug-­‐sensi4ve  and   resistant  cell  types   •  analysis  of  cellular  pathways,  prognos4c,  diagnos4c,  and  efficacy   markers   •  ex  vivo  phenotype  and  drug  response  analysis  of  target  4ssues    
  • 8. 8   Research  Capabilities  (contd) •  extensive  experience  in  molecular  and  applied  immunology  developing   and  tes4ng  new  reagents  for  immunotherapy  and  immunodiagnos4cs   •  development  of  sensi4ve  and  robust  immuno-­‐assays,  other     bioaffinity  assays,  screens   •  custom  diagnos4c  and  therapeu4c  an4bodies     •  protein-­‐based,  virus-­‐based    and  other  immunomodulatory     drug  research     Immunology Lab Microbiology Lab A  typical  research  project  involves    contribuTon  of  experts    from    2-­‐3  Lab  teams  as  well   as  Core  faciliTes.  AddiTonal  experTse  and  resources  (e.g.  TMAs,  HTS,  genomics)  are   engaged  via  subcontracTng  of  academic  partners  (such  as  Roswell  Park  Cancer  InsTtute)   •  in  vitro  and  in  vivo  (mouse  models)  support  of  an4-­‐infec4ve  drug   development   •  experienced  with  bacterial  and  fungal  pathogens   •  in  vitro  tes4ng  of  an4microbial  potency  and  toxicity  on  human  cells,   support  of  SAR   •  an4-­‐infec4ve  efficacy  by  survival  and/or  pathogen  burden  readouts    
  • 9. 9   Core  Service  Capabilities •  access  to  state-­‐of-­‐the-­‐art  animal  facility   •  unique  colonies  of  mice  including  syngeneic  and  xenogra_  models     •  variety  of  animal  models  including  cancer,  infec4on,  irradia4on,   chemical  tox   •  expertly  designed  and  conducted  animal  studies  of  desired  scope  (tox,   survival  efficacy,  etc.),  scale  (from  single  to  thousands  of    mice),  types   of  treatment  (surgical,  various  admin  routes)                                                                                                                       Animal Core Histology Core Chemistry Bioanalytics •  pathology,  histomorphology  and  immunohistochemistry   •  prepara4on  and  histological  analysis  of  samples  from  all  4ssues  types   •  rou4ne  &  customized  methodology,  experienced  interpreta4on  of  results   •  high-­‐end  histology  microscopes,  microtomes,  cryostats     •  professional  analy4cal  support  of  pharmacological  studies     •  formula4on  and  analysis  of  drug  substances  for  in  vitro  and  in  vivo  studies   •  solubility,  stability,  toxicity,  PK  and  PD  studies  of  chemical  and  biological   drug  candidates   •  specialized  equipment  including  HPLC  and  LC-­‐MS   Providing  robust  methodology  support  of  integrated  research     projects  and  direct  services  to  customers.  
  • 10. 10   Example  Featured  Research  Area              Antimicrobial  Drug  Development Chemistry Core Animal Core Microbiology Lab RPCIIn  Vitro  Evalua9on   Potency  of  drug  candidates   ⇒  MIC  against  major  fungal  pathogens  Candida  and  Aspergillus  spp.   ⇒ MIC  and  MBC  against  aerobic  bacterial  pathogens  (Staphylococcus,  Enterococcus,  etc.)   Toxicity   ⇒  on  a    panel  of  representa4ve  mammalian  cell  lines   Acquired  drug  resistance   ⇒Drug  candidate  tes4ng  vs.  standard-­‐of-­‐care     In  Vivo  Evalua9on   Toxicity,  PK   ⇒ formula4on,  maximum  tolerated  dose  (sMTD  and  rMTD)   ⇒ pharmacokine4cs,  4ssue  distribu4on   Potency   ⇒ mouse  models,  including  immunosuppressed  mice  models  of  candidiasis  and  aspergillosis     ⇒ compare  administra4on  routes  (i.v.,  i.p.,  oral,  oropharyngeal),  treatment  regimens   ⇒ endpoints:    survival,  pathogen  burden,  4ssue  damage   ⇒ biomarkers  of  efficacy,  mechanis4c  studies