Cetya CSU Ventures Press release...

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Cetya Therapeutics Announces Issuance of Third Patent on Largazole Analogs Patent extends and strengthens largazole analog patent estate with additional composition of matter claims Fort Collins, CO, December 14, 2015 – Cetya Therapeutics, Inc. announces the issuance of a third patent to Colorado State University Ventures covering its proprietary portfolio of analogs of the Class I isoform selective histone deacetylase (HDAC) inhibitor largazole. Claims in US Patent No. 9,186,402 include both field of use and composition of matter on selected analogs. Cetya has inlicensed exclusive worldwide rights to the patent estate developed in the laboratory of Dr. Robert M. Williams, University Distinguished Professor of Chemistry at CSU. Histone deacetylases are a family of enzymes that catalyze removal of acetyl groups from lysine residues on histone proteins leading to gene repression. Thus, the expression level of genes known to enhance or suppress cancer initiation and progression can be regulated depending on the acetylation state of histones. Three HDAC inhibitors have been approved by the FDA for the treatment of Tcell lymphoma and one for treatment of multiple myeloma, validating HDACs as targets for drug development. Dr. Williams and colleagues have developed synthetic processes that provide for the production of numerous largazole analogs. Certain of these analogs have been shown to effectively inhibit HDACs at low nanomolar concentrations, with the ability to include a targeting moiety without significant loss of potency, a capability unique to Cetya. “Largazole is among the most potent HDAC inhibitors known, and we are thrilled to be awarded additional coverage on this unique chemical scaffold,” stated Dr. Williams. The largazole analogs represent an opportunity to develop HDAC inhibitors that may mitigate dose limiting toxicities and serious adverse events that have plagued HDAC inhibitor drug development. Moreover, current HDAC inhibitors in development have shown limited efficacy against solid tumors. Cetya believes its proprietary platform is uniquely positioned to overcome this limitation based on the unique inhibitory activity, improved pharmacokinetic profiles, and novel prodrug structures of our compounds. As a drug class, HDAC inhibitors have been demonstrated to be effective in treating certain cancers and thought leaders in epigenetics believe that this class of compounds may have much broader application in treating hemoglobinopathies, inflammation, cardiopathies, neurological disorders and fibrotic diseases. These indications will be investigated as the preclinical dataset around Cetya’s analogs matures. Clifford L. Hendrick, CEO of Cetya, stated, “Dr. Williams’ ability to modify the structure of largazole at a variety of locations without substantial loss of potency enables Cetya to pursue a number of clinical indications which have not been explored to date with HDAC inhibitors.”

Transcript of Cetya CSU Ventures Press release...

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Cetya  Therapeutics  Announces  Issuance  of  Third  Patent    on  Largazole  Analogs  

 Patent  extends  and  strengthens  largazole  analog  patent  estate  with  additional  

composition  of  matter  claims    

Fort  Collins,  CO,  December  14,  2015  –  Cetya  Therapeutics,  Inc.  announces  the  issuance  of  a  third  patent  to  Colorado  State  University  Ventures   covering   its  proprietary  portfolio  of  analogs  of   the  Class   I   isoform-­‐selective  histone  deacetylase  (HDAC)  inhibitor  largazole.    Claims  in  US  Patent  No.  9,186,402  include  both  field  of  use  and  composition  of  matter  on  selected  analogs.    Cetya  has   in-­‐licensed  exclusive  worldwide  rights  to  the  patent  estate  developed  in  the  laboratory  of  Dr.  Robert  M.  Williams,  University  Distinguished  Professor  of  Chemistry  at  CSU.    Histone  deacetylases  are  a  family  of  enzymes  that  catalyze  removal  of  acetyl  groups  from  lysine  residues  on  histone  proteins  leading  to  gene  repression.    Thus,  the  expression  level  of  genes  known  to  enhance  or  suppress   cancer   initiation   and   progression   can   be   regulated   depending   on   the   acetylation   state   of  histones.    Three  HDAC  inhibitors  have  been  approved  by  the  FDA  for  the  treatment  of  T-­‐cell  lymphoma  and  one  for  treatment  of  multiple  myeloma,  validating  HDACs  as  targets  for  drug  development.      Dr.   Williams   and   colleagues   have   developed   synthetic   processes   that   provide   for   the   production   of  numerous   largazole  analogs.    Certain  of   these  analogs  have  been  shown  to  effectively   inhibit  HDACs  at  low  nanomolar  concentrations,  with  the  ability   to   include  a  targeting  moiety  without  significant   loss  of  potency,  a  capability  unique  to  Cetya.    “Largazole  is  among  the  most  potent  HDAC  inhibitors  known,  and  we  are  thrilled  to  be  awarded  additional  coverage  on  this  unique  chemical  scaffold,”  stated  Dr.  Williams.  The   largazole   analogs   represent   an   opportunity   to   develop   HDAC   inhibitors   that   may   mitigate   dose-­‐limiting   toxicities   and   serious   adverse   events   that   have   plagued   HDAC   inhibitor   drug   development.    Moreover,   current   HDAC   inhibitors   in   development   have   shown   limited   efficacy   against   solid   tumors.    Cetya  believes   its  proprietary  platform  is  uniquely  positioned  to  overcome  this   limitation  based  on  the  unique   inhibitory   activity,   improved   pharmacokinetic   profiles,   and   novel   prodrug   structures   of   our  compounds.      As  a  drug  class,  HDAC  inhibitors  have  been  demonstrated  to  be  effective  in  treating  certain  cancers  and  thought  leaders  in  epigenetics  believe  that  this  class  of  compounds  may  have  much  broader  application  in   treating   hemoglobinopathies,   inflammation,   cardiopathies,   neurological   disorders   and   fibrotic  diseases.     These   indications   will   be   investigated   as   the   preclinical   dataset   around   Cetya’s   analogs  matures.     Clifford   L.   Hendrick,   CEO   of   Cetya,   stated,   “Dr.   Williams’   ability   to   modify   the   structure   of  largazole  at  a  variety  of  locations  without  substantial  loss  of  potency  enables  Cetya  to  pursue  a  number  of  clinical  indications  which  have  not  been  explored  to  date  with  HDAC  inhibitors.”            

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                                                                                                       About  Cetya  Therapeutics    Cetya   Therapeutics,   Inc.   is   a   Delaware   C-­‐Corporation   formed   in   2012   to   develop   histone   deacetylase  inhibitors  based  on  largazole.  Some  of  these  analogs  have  bifunctional  modifications  with  the  potential  to  target   specific   cell   types   or   tumors.     This   is   unique   in   the   HDAC   inhibitor   space   and,   together   with  potency  and  selectivity,  differentiates  Cetya’s  compounds.    Cetya  holds  exclusive  worldwide  rights  to  the  largazole   analog   intellectual   property   created   by   Dr.   Robert  M.  Williams   at   Colorado   State   University.    More   than   40   largazole   analogs   have   been   synthesized,   some   with   best-­‐in-­‐class   profiles   as   HDAC  inhibitors.    Biochemical  and  cell-­‐based  potency,  upregulation  of  fetal  hemoglobin  expression  and  in-­‐vivo  anti-­‐cancer   activity   have   been   demonstrated.     Cetya   is   seeking   corporate   partners   to   assist   in   the  advancement  of  its  analog  portfolio  into  clinical  studies  in  a  number  of  different  therapeutic  indications.        For  more  information  on  Cetya,  please  visit  our  website  at  cetya-­‐therapeutics.com.    About  CSU  Ventures    CSU  Ventures   Inc.   is   a   501(c)(3)  nonprofit   corporation   that   is   dedicated   to   the  business   of   technology  transfer   and   commercialization   at   Colorado   State   University,   bringing   innovations   and   technologies  discovered  at  CSU  into  the  marketplace  for  the  benefit  of  society.  With  expertise  in  intellectual  property,  licensing,  partnership-­‐building,  and  entrepreneurship,  CSU  Ventures  protects,  manages  and  transfers  CSU  innovations  by  connecting  individuals  and  companies  with  University  researchers.  CSU  Ventures  serves  as  a  resource  not  only  to  CSU  faculty  and  researchers,  but  also  to  industry,  entrepreneurs,  and  investors  seeking   to   further   research   or   commercialize   a   technology.   The  work   of   CSU   Ventures   results   in   new  products,   businesses,   and   jobs   that   positively   impact   economic   growth   for   Colorado   and   society   as   a  whole.    Originally  established  in  1963  as  Colorado  State  University  Research  Foundation  (CSURF),  we  are  now  known  as  CSU  Ventures,  a  non-­‐profit  corporation  and  a  wholly  owned  subsidiary  of  CSURF.    For  more  information  on  CSU  Ventures,  please  visit  our  website  at  www.csuventures.org.