AstraZeneca, Pharmacyclics and Janssen partner on immuno-oncology combination trials with IMBRUVICA® for haematological cancers

Tuesday, 4 November 2014

AstraZeneca, Pharmacyclics, Inc. and Janssen Research & Development, LLC (“Janssen”) today announced that they have entered into a clinical trial collaboration to evaluate the efficacy and safety of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with IMBRUVICA® (ibrutinib), an oral Bruton’s tyrosine kinase inhibitor, co-developed by Pharmacyclics and Janssen and commercialised outside the US by Janssen affiliates. The study will assess the combination as a treatment for patients with haematological cancers including diffuse large B-cell lymphoma and follicular lymphoma, which are investigational uses for both compounds.

MEDI4736 blocks the signals that help tumours avoid detection by the immune system, countering the tumour’s immune-evading tactics. Ibrutinib blocks signals that tell malignant B cells (white blood cells that produce antibodies) to multiply and spread uncontrollably. Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumour immune response.

The Phase I part of the trial is expected to establish a recommended dose regimen for the combination of MEDI4736 and ibrutinib, and the Phase IIa part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the two-part trial will be conducted by Pharmacyclics. The financial terms of the agreement have not been disclosed.

Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “We are committed to progressing our strong immuno-oncology pipeline as rapidly as possible. Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in haematological cancers – an area of significant unmet need as many lymphoma patients still progress despite treatment. It is also further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer.”

“We are delighted by our strategic collaboration with AstraZeneca as we explore the potential of IMBRUVICA in combination with immunotherapy to address a variety of haematological cancers in which we already have deep experience and an ongoing scientific interest,” said Bob Duggan, Chairman & CEO, Pharmacyclics. “We look forward to working with our partners as we advance our understanding of different ways in which to continue to evolve treatment paradigms and expand treatment options for patients with certain B-cell malignancies.”

“Cancer drug development is at one of its most exciting, productive periods in history,” said Peter Lebowitz, MD, PhD, Global Oncology Head, Janssen. “This collaboration reflects the common goal of all three companies to better understand new treatment options and combinations – with the ultimate goal of making a difference to the lives of people with haematological malignancies.”

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, or adult patients with chronic lymphocytic leukaemia 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 the Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssenrnd.com for more information.

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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