TOKYO and LONDON, January 7,
2019 /PRNewswire/ --
Milestone achieved with next generation immuno-oncology
candidate AZD4635, a novel adenosine 2A receptor antagonist
Sosei Group Corporation ("the Company"; TSE: 4565), announces it
has been notified today by its strategic alliance partner
AstraZeneca (LSE: AZN) that it has reached a clinical development
milestone with its partnered next generation immuno-oncology
candidate AZD4635, triggering a US$15
million payment from AstraZeneca.
AZD4635 is a potent and selective, orally available, small
molecule adenosine 2A receptor antagonist discovered by the Company
and exclusively licensed to AstraZeneca globally in 2015. The
candidate has been advancing through a Phase 1 clinical program as
a single agent and in combination with AstraZeneca's anti-PD-L1
antibody durvalumab (IMFINZI®) in patients with solid tumours.
The clinical study to date has established the maximum-tolerated
dose of AZD4635 as a single agent and in combination with
durvalumab. The study has progressed successfully to the point
where the therapeutic potential of AZD4635 is being explored in
multiple solid tumours. As a result, AstraZeneca is moving the
trial towards Phase 2, thereby triggering the milestone payment to
Sosei Heptares. Headline data from the Phase 1 study is planned to
be presented at a scientific congress in 2019.
"At AstraZeneca, we are exploring next generation
immuno-oncology approaches by seeking to develop novel combinations
that overcome key immunosuppressive mechanisms, and thereby expand
the potential for anti-tumour activity of immune checkpoint
inhibition. It is increasingly recognised that the adenosine
pathway is critical in tumour immunosuppression and AZD4635
complements our portfolio in this area," said
Susan Galbraith, Senior
Vice President and Head of Oncology, Innovative Medicines and Early
Development (IMED) Biotech Unit at
AstraZeneca.
Dr. Malcolm Weir, Executive VP
and Chief R&D Officer, said: "Adenosine production in the
tumour microenvironment is becoming well-recognised as a key
survival mechanism employed by tumour cells to evade immune
detection and destruction. Our A2A antagonist AZD4635, which aims
to block this mechanism and make tumour cells vulnerable again to
the immune system, has made very encouraging and rapid progress in
partnership with AstraZeneca, a world leader in immuno-oncology. We
believe this is a very exciting candidate and look forward to
results from these initial clinical studies in due course."
The Company expects to receive the $15
million payment by the end of the first quarter ended
31 March 2019.
About adenosine-mediated immune evasion and A2A receptor
antagonists
Tumour cells have evolved mechanisms to evade the immune system,
including through the production of a natural anti-inflammatory
molecule called adenosine. By stimulating A2A receptors, adenosine
prevents T-cells within the immune system from being activated and
reduces their ability to destroy cancer cells. Blocking A2A
receptors can therefore promote the anti-cancer response of T-cells
within the tumour microenvironment.
In preclinical studies, AZD4635 has been shown to be effective
in reversing adenosine-mediated T-cell suppression and enhancing
anti-tumour immunity. Blockade of A2A signalling with AZD4635 was
found to reduce tumour growth when used alone and in combination
with anti-PD-L1 checkpoint inhibitors (presented at the 2017
American Association of Cancer Research Annual Meeting).
About the clinical studies with AZD4635
AZD4635 is in a Phase 1 open-label, multicenter study as a
single agent and in combination with a PD-L1 antibody, durvalumab
in patients with solid malignancies. ClinicalTrials.gov
Identifier: NCT02740985
AZD4635 is also in a Phase 1/2a open-label, multicenter, study
in combination with oleclumab (formerly MEDI9447), an anti-CD73
antibody developed by MedImmune, in patients with previously
treated advanced EGFR-driven non-small cell lung cancer
(NSCLC).ClinicalTrials.gov Identifier: NCT03381274
About Sosei Heptares
We are an international biopharmaceutical group 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, immuno-oncology,
gastroenterology, inflammation and other rare/specialty
indications. Its leading clinical programs include partnered
candidates aimed at the symptomatic treatment of Alzheimer's
disease (with Allergan) and next generation immuno-oncology
approaches to treat cancer (with AstraZeneca). Our additional
partners and collaborators include Novartis, Pfizer,
Daiichi-Sankyo, PeptiDream, Kymab and MorphoSys. The Company is
headquartered in Tokyo, Japan with
R&D facilities in Cambridge,
UK and Zurich,
Switzerland.
"Sosei Heptares" is the corporate brand of Sosei Group
Corporation, which is listed on the Tokyo Stock Exchange (ticker:
4565). For more information, please visit
http://www.soseiheptares.com.
Forward-looking statements
This press release contains forward-looking statements,
including statements about the discovery, development and
commercialization of products. Various risks may cause Sosei Group
Corporation'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 commercialize 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 commercialization
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.