AstraZeneca and Pharmacyclics enter clinical trial collaborations in oncology

Tuesday, 4 November 2014

Studies planned to evaluate IMBRUVICA® in combination with AstraZeneca investigational therapies for the treatment of solid tumours and haematological cancers

AstraZeneca and Pharmacyclics, Inc. today announced that they have entered into clinical trial collaborations to evaluate novel combination therapies targeting solid tumours and a number of haematological cancers.

The first collaboration, focusing on solid tumours, will evaluate the efficacy and safety of IMBRUVICA® (ibrutinib), Pharmacyclics’ oral Bruton's tyrosine kinase inhibitor in combination with AstraZeneca’s anti-PD-L1 antibody, MEDI4736.

The second collaboration will focus on haematological cancers and will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors with IMBRUVICA, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphomas. Preclinical evidence suggests that the combination of IMBRUVICA with these investigational medicines may enhance their effects.

Under the terms of the agreements, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple Phase I and Phase IIa studies may be considered and conducted. The studies focused on solid tumours will be led by Pharmacyclics, while AstraZeneca will lead those exploring haematological cancers. The Phase I element of each study is expected to establish a recommended safe and tolerable dose and schedule for the combination and the Phase IIa element will assess its safety and efficacy in an expanded patient population. The financial terms of the agreement have not been disclosed. The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted.

Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit said: “There is a clear and significant unmet need in the treatment of haematological malignancies, an area of increasing focus for AstraZeneca. Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes.”

“We are optimistic that combining our oral once-per-day IMBRUVICA with other agents has the potential to enhance efficacy and duration across the landscape of haematological cancers,” said Bob Duggan, Chairman & CEO, Pharmacyclics. “In addition, we are extremely interested in the potential for IMBRUVICA in combination with an anti-PD-L1 antibody to improve the treatment of solid tumours in patients who need better therapeutic options.”

NOTES FOR EDITORS

About IMBRUVICA® Ibrutinib

IMBRUVICA is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics Switzerland GmbH. Janssen affiliates market IMBRUVICA in Europe, Middle East and Africa as well as the rest of the world, except for the US, where both companies co-market it.

IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA received marketing authorisation from the European Commission in October 2014 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

IMBRUVICA is the only compound to have received three Breakthrough Therapy Designations from the U.S. FDA. IMBRUVICA was also one of the first medicines to receive such designation.

IMBRUVICA is a registered trademark of Pharmacyclics, Inc.

About MEDI4736

MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer.

MEDI4736 is in development as monotherapy in solid tumours. It is currently in Phase III development for patients with non-small cell lung cancer and clinical trials are due to commence in 2014 for patients with squamous cell carcinoma of the head and neck. AstraZeneca and MedImmune, its biologics research and development arm, also have a broad programme of immuno-oncology combination trials underway, including MEDI4736 + tremelimumab (CTLA-4), MEDI4736 + MEDI0680 (PD-1), MEDI4736 + MEDI6469 (OX40) and MEDI4736 + IRESSA (epidermal growth factor receptor-tyrosine kinase inhibitor).

About Pharmacyclics

Pharmacyclics, Inc. (NASDAQ: PCYC) is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. The company’s mission is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life, and resolve serious unmet medical needs. It will do so by identifying and controlling promising product candidates based on scientific development and administrative expertise, developing its products in a rapid, cost-efficient manner and, pursuing commercialization and/or development partners when and where appropriate.

Pharmacyclics markets IMBRUVICA and has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to commercialization. Pharmacyclics is headquartered in Sunnyvale, CA. To learn more, visit www.pharmacyclics.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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