Arix Bioscience PLC (ARIX) Artios initiates Phase 2 study of
Pol? 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 Pol? 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 (Pol?) 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 Pol? polymerase domain to enter the clinic. Pol?, 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 Pol? 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:
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
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil
+44 (0)20 7250 1446
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.
www.arixbioscience.com
Artios Press Release
Artios initiates Phase 2 study of Pol? 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 thePol? 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 2data 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
(Pol?) 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 Pol? polymerase domain to enter the clinic. Pol?, 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 Pol? 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: "Pol?
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 Pol? 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 Pol? 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 USUSD860 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 USUSD20 million
up-front payment in addition to near-term research funding to
support the collaboration. Artios is eligible to receive up to
USD1.3 billion in discovery, development, regulatory and
sales-based milestones in addition to royalty payments. Artios has
raised USUSD320 million to date from investors and strategic
partners, including the USUSD153 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
End of Announcement EQS News Service
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