REG-Arix Bioscience PLC Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination with PARP Inhibitor Talazoparib in BRCA Deficient Breast Cancer

Arix BioscienceAnnouncement

10/08/2022 18:15

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   Arix Bioscience PLC (ARIX)
   Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination
   with PARP Inhibitor Talazoparib in BRCA Deficient Breast Cancer

   10-Aug-2022 / 18:05 GMT/BST
   Dissemination of a Regulatory Announcement, transmitted by EQS Group.
   The issuer is solely responsible for the content of this announcement.

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                              Arix Bioscience plc

                                        

    Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination
        with PARP Inhibitor Talazoparib in BRCA Deficient Breast Cancer

    

   LONDON, UK,  10 August 2022: Arix Bioscience plc (“Arix” or the “Company”)
   (LSE: ARIX),  a global  venture capital  company focused  on investing  in
   breakthrough biotechnology companies,  notes that  its portfolio  company,
   Artios Pharma,  today announced  it has  initiated a  Phase 2  study  with
   ART4215,  a  small  molecule  inhibitor  of  polymerase  theta  (Polθ)  in
   combination  with  talazoparib  (TALZENNA®),  an  oral  poly  (ADP-ribose)
   polymerase (PARP) inhibitor  in an  expansion study for  the treatment  of
   BRCA deficient breast cancer.

    

   ART4215 is the first selective, oral, small molecule inhibitor of the Polθ
   polymerase domain  to enter  the  clinic. Polθ,  a  DNA polymerase,  is  a
   tumor-specific DDR target involved  in microhomology mediated end  joining
   (MMEJ) that is  overexpressed in many  tumors and found  in low levels  in
   healthy tissue.  Extensive  preclinical  studies  have  demonstrated  that
   ART4215 has  broad potential  clinical utility,  as described  in  Artios’
   recent Nature Communications publication, Zatreanu et al., 2021. The  Polθ
   project was originally  in-licensed from Cancer  Research Technology  (now
   Cancer Research Horizons)  in 2016  as part  of the  initial formation  of
   Artios.

    

   The   announcement   can    be   accessed   on    Artios’   website    at:
    1 https://www.artios.com/ and  the full  text  of the  announcement  from
   Artios is contained below.

    

    

                                      ENDS 

   For more information on Arix, please contact:

    

   Arix Bioscience plc

   +44 (0)20 7290 1050

    2 ir@arixbioscience.com  

    

   Powerscourt Group

   Sarah MacLeod, Ibrahim Khalil

   +44 (0)20 7250 1446

    3 arix@powerscourt-group.com

    

   About Arix Bioscience plc

   Arix Bioscience  plc  is  a  global venture  capital  company  focused  on
   investing in  breakthrough  biotechnology  companies  around  cutting-edge
   advances in life sciences.

   We collaborate  with exceptional  entrepreneurs and  provide the  capital,
   expertise, and  global  networks  to  help  accelerate  their  ideas  into
   important new treatments for patients. As a listed company, we are able to
   bring this exciting  growth phase of  our industry to  a broader range  of
   investors.  4 www.arixbioscience.com

    

    

                              Artios Press Release

                                        

    Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination
        with PARP Inhibitor Talazoparib in BRCA Deficient Breast Cancer

    

     • ART4215 is a potentially first-in-class, highly selective, oral small
       molecule inhibitor targeting the Polθ polymerase domain
     • Interim Phase 1 tolerability and pharmacokinetic data supports a
       well-tolerated safety profile
     • Phase 1 safety and tolerability data for ART4215 in advanced solid
       tumors is expected in 1H 2023; Phase 2 data in BRCA deficient breast
       cancer is expected in 2024

   CAMBRIDGE, UK and  NEW YORK, USA,  10 August 2022:  Artios Pharma  Limited
   (Artios), a clinical stage biotech  company pioneering the development  of
   novel small  molecule therapeutics  that target  the DNA  damage  response
   (“DDR”) process in order to treat patients with a broad range of  cancers,
   announces it has initiated a Phase 2 study with ART4215, a small  molecule
   inhibitor of  polymerase  theta  (Polθ) in  combination  with  talazoparib
   (TALZENNA®), an oral poly (ADP-ribose)  polymerase (PARP) inhibitor in  an
   expansion study for the treatment of BRCA deficient breast cancer.

   ART4215 is the first selective, oral, small molecule inhibitor of the Polθ
   polymerase domain  to enter  the  clinic. Polθ,  a  DNA polymerase,  is  a
   tumor-specific DDR target involved  in microhomology mediated end  joining
   (MMEJ) that is  overexpressed in many  tumors and found  in low levels  in
   healthy tissue.  Extensive  preclinical  studies  have  demonstrated  that
   ART4215 has  broad potential  clinical utility,  as described  in  Artios’
   recent Nature Communications publication, Zatreanu et al., 2021. The  Polθ
   project was originally  in-licensed from Cancer  Research Technology  (now
   Cancer Research Horizons)  in 2016  as part  of the  initial formation  of
   Artios.

   Dr. Niall Martin, Chief Executive Officer at Artios, said: “Polθ is highly
   expressed in cancer cells,  but has limited  expression in healthy  cells,
   making it an  attractive cancer target.  Initial Phase 1  data supports  a
   favorable tolerability profile and the potential for broad treatment  use,
   particularly  in  combination  with  agents  like  PARP  inhibitors  where
   combinations with other DNA damage  response inhibitors have been  limited
   by toxicity.  We  are highly  encouraged  that  ART4215 may  offer  a  new
   treatment option that can synergize to overcome both de novo and  acquired
   PARP  resistance.  We  look  forward  to  reporting  Phase  1  safety  and
   tolerability data in the first half of 2023.”

   Principal Investigator for the trial,  Dr. Erika P. Hamilton, Director  of
   the Breast Cancer  and Gynecologic Cancer  Research Program, Sarah  Cannon
   Research Institute at  Tennessee Oncology, said:  “Patients with  advanced
   solid tumors have achieved improved outcomes with the development of  PARP
   inhibitors.  However,  there  is  still  a  need  to  address   resistance
   mechanisms diminishing  initial tumor  responses  and leading  to  disease
   progression. ART4215 has the potential to help overcome these limitations,
   and we are excited that the initiation of this Phase 2 trial represents an
   important step in the clinical evaluation of Polθ as a novel target.”

   ART4215 is  currently  being  evaluated  in  an  ongoing,  first-in-human,
   global, open-label Phase  1/2 study  to assess  the safety,  tolerability,
   pharmacokinetics, and clinical activity of ART4215 as a monotherapy or  in
   combination with talazoparib in patients with advanced or metastatic solid
   tumors. Initial  safety data  from the  first Phase  1 dose  cohorts  have
   demonstrated ART4215 to be well tolerated. A recommended Phase 2 dose  has
   been established  for  ART4215  in combination  with  talazoparib,  and  a
   randomized expansion cohort has been initiated to evaluate the combination
   in patients with BRCA deficient breast cancer.

   The study will enroll up to 206 patients and will be conducted at multiple
   oncology centers across the USA and Europe. The trial is led by  principal
   investigators Erika P. Hamilton, M.D.,  Director of the Breast Cancer  and
   Gynecologic Cancer Research  Program, Sarah Cannon  Research Institute  at
   Tennessee Oncology, and Timothy Yap, M.B.B.S., Ph.D., Associate  Professor
   of  Investigational  Cancer  Therapeutics  and  Medical  Director  of  the
   Institute for  Applied  Cancer  Science  at The  University  of  Texas  MD
   Anderson Cancer Center. Phase 1  safety and tolerability data is  expected
   in the first half of 2023.

   END

   About Artios

   zArtios is a clinical-stage biotech company pioneering the development  of
   novel small molecule  therapeutics that  target the DDR  process to  treat
   patients suffering from  a broad  range of cancers.  Artios is  led by  an
   experienced scientific and  leadership team with  proven expertise in  DDR
   drug discovery, including the discovery and early development of the  poly
   (adenosine diphosphate-ribose)  polymerase (PARP)  inhibitor Olaparib.  It
   has a unique partnership with Cancer Research UK, and collaborations  with
   leading DNA repair researchers worldwide, such as The Institute of  Cancer
   Research,  London,  the  Netherlands   Cancer  Institute  and  the   Crick
   Institute, London. Artios  is building a  pipeline of next-generation  DDR
   programs to target  hard to  treat cancers, including  its ATR  inhibitor,
   ART0380, and  the  Polθ inhibitor,  ART4215,  as a  monotherapy  and  with
   combination  treatments.  In   December  2020,  Artios   entered  into   a
   collaboration agreement with  Merck KGaA, Darmstadt,  Germany to  identify
   and develop precision oncology medicines targeting nucleases. Merck  KGaA,
   Darmstadt, Germany has  the right  to opt into  exclusive development  and
   commercialization of compounds  on up to  eight targets and  Artios is  to
   receive up to  US$860 million  in total  milestones per  target. In  April
   2021, Artios  entered  into a  collaboration  agreement with  Novartis  to
   identify  DDR  targets  to  use  with  Novartis’  proprietary  radioligand
   therapies, with  Artios  receiving a  US$20  million up-front  payment  in
   addition to  near-term  research  funding to  support  the  collaboration.
   Artios  is  eligible  to  receive   up  to  $1.3  billion  in   discovery,
   development, regulatory and sales-based milestones in addition to  royalty
   payments. Artios  has raised  US$320 million  to date  from investors  and
   strategic partners,  including  the  US$153  million  Series  C  financing
   announced in July 2021. Artios is based at the Babraham Research Campus in
   Cambridge, UK, with an office in New York City, USA.

                                        

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   ISIN:           GB00BD045071
   Category Code:  PFU
   TIDM:           ARIX
   LEI Code:       213800OVT3AHQCXNIX43
   OAM Categories: 3.1. Additional regulated information required to be
                   disclosed under the laws of a Member State
   Sequence No.:   180590
   EQS News ID:    1417999


    
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