Sosei Provides an Update on Its Immuno-Oncology Clinical Program with AstraZeneca
08 Febbraio 2018 - 12:30AM
Business Wire
- Primary objectives near completion in
ongoing Phase 1 clinical study with AZD4635, a novel selective
adenosine A2A receptor antagonist
- First patient dosed in Phase 1b
clinical study
- New clinical combination study
involving AZD4635 expected to begin in first quarter 2018
Sosei Group Corporation (“Sosei” or the “Company”) (TOKYO:
4565), the world leader in GPCR medicine design and development,
announces that its immuno-oncology collaboration with AstraZeneca
is progressing well. The first patient has been dosed in an
expansion cohort in the Phase 1b segment of the Phase 1 study in
advanced solid tumours. Furthermore, a new clinical study including
AZD4635 to investigate novel combination therapies in EGFRm
non-small cell lung cancer is expected to begin in the first
quarter 2018.
AZD4635 is a potent and selective, orally available, small
molecule adenosine A2A receptor (A2AR) antagonist discovered by
Sosei subsidiary Heptares Therapeutics and licensed to AstraZeneca
in 2015.
AZD4635 is currently in a Phase 1 clinical trial for patients
with advanced solid malignancies, the primary objective of which is
to determine maximum tolerated dose (MTD) of AZD4635 alone and in
combination with AstraZeneca’s anti-PD-L1 antibody durvalumab.
Phase 1b expansion cohorts in advanced solid tumours, are now open
and the first patient has been dosed. The trial, sponsored by
AstraZeneca, is expected to complete in the second half of 2019.
For information on this study please refer to clinicaltrials.gov,
trial # NCT02740985.
AstraZeneca, with its global biologics research and development
affiliate, MedImmune, is also planning a new clinical study to
assess safety, tolerability and anti-tumour activity of novel
combination therapies in subjects with advanced epidermal growth
factor receptor (EGFRm) mutated non-small cell lung cancer (NSCLC).
This Phase 1b/2* study will evaluate the combination of MEDI9447
(an anti-CD73 antibody developed by MedImmune) with AZD4635 or
TAGRISSO® (osimertinib), an EGFR tyrosine kinase inhibitor for
NSCLC developed by AstraZeneca. For information on this study
please refer to clinicaltrials.gov, trial #NCT03381274.
“We are pleased with the progress made with AZD4635 in the Phase
1 clinical study under our partnered immuno-oncology program with
AstraZeneca. We are also delighted that AstraZeneca and MedImmune
are evaluating AZD4635 in a new clinical study in combination with
the anti-CD73 antibody, MEDI9447 in EGFRm non-small cell lung
cancer,” commented Dr. Tim Tasker, Sosei’s Chief Medical Officer.
“Blocking adenosine-mediated immune suppression is an attractive
new mechanism for treating a range of cancers and development of
this novel candidate could result in a potential new treatment as a
monotherapy or in combination to improve the efficacy of checkpoint
inhibitors and other drug classes.”
* Entry into initial new Phase 1b study does not trigger a
milestone payment
Notes to Editors
About AZD4635
AZD4635 is a potent and selective, orally available, small
molecule adenosine A2A receptor (A2AR) antagonist discovered by
Sosei subsidiary Heptares Therapeutics and licensed to AstraZeneca
in 2015. AZD4635 blocks A2A receptor signalling and prevents an
evolved survival mechanism of tumours from being effective at the
level of the immune cell. By stimulating A2A receptors, adenosine,
a natural anti-inflammatory molecule, is released preventing
T-cells within the immune system from being activated and reduces
their ability to destroy cancer cells. A2A receptor antagonism can
therefore promote the anti-cancer response of T-cells within the
tumour microenvironment, offering a novel mechanism of action as a
mono- or combination therapy.
About Sosei
Sosei is an international biopharmaceutical company focused on
the design and development of new medicines originating from its
proprietary GPCR-targeted StaR® technology and structure-based drug
design platform capabilities. The Company is advancing a broad and
deep pipeline of partnered and wholly owned product candidates in
multiple therapeutic areas, including CNS, cancer, metabolic
diseases and other rare/specialty indications. The Company’s
leading clinical programs include a proprietary Phase 2 candidate
for dementia with Lewy bodies (DLB) in Japan, together with
partnered candidates aimed at the symptomatic treatment of
Alzheimer’s disease (with Allergan) and immuno-oncology approaches
to treat cancer (with AstraZeneca). Sosei’s additional partners and
collaborators include Novartis, Teva, Pfizer, Daiichi-Sankyo,
PeptiDream, Kymab and MorphoSys. The Company is headquartered in
Japan with R&D facilities in the UK.
Sosei is listed on the Mothers Index of the Tokyo Stock Exchange
(TOKYO: 4565). For more information, please visit
http://www.sosei.com/en/.
Forward-looking statements
This press release contains forward-looking statements,
including statements about the discovery, development and
commercialisation of products. Various risks may cause Sosei’s
actual results to differ materially from those expressed or implied
by the forward-looking statements, including: adverse results in
clinical development programs; failure to obtain patent protection
for inventions; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic alliance
partners to develop and commercialise products and services;
difficulties or delays in obtaining regulatory approvals to market
products and services resulting from development efforts; the
requirement for substantial funding to conduct research and
development and to expand commercialisation activities; and product
initiatives by competitors. As a result of these factors,
prospective investors are cautioned not to rely on any
forward-looking statements. We disclaim any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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Sosei Group CorporationChris Cargill, +44 (0)7912 892 199Head of
Investor Relations and Corporate
Communicationsccargill@sosei.comorSosei Group CorporationHarumi
Banse, +81 3 5210 3399Corporate Communications
(Japan)hbanse@sosei.comorCitigate Dewe Rogerson (for International
media)Mark Swallow / David Dible, +44 (0)20 7638
9571sosei@citigatedewerogerson.com