Press release

Feb 8, 2018

Sosei provides an update on its immuno-oncology clinical program with AstraZeneca

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

Tokyo, Japan and London, UK, 8 February 2018 – Sosei Group Corporation (“Sosei” or the “Company”; TSE Mothers Index: 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.

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