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阿斯利康与协和发酵麒麟合作开发免疫鸡尾酒疗法

来源:生物谷 2014-07-31 14:37

2014年7月31日讯 /生物谷BIOON/ --阿斯利康(AZN)7月30日宣布,与日本协和发酵麒麟株式会社(Kyowa Hakko Kirin)达成一项临床研究合作,开展一项I/Ib期免疫-肿瘤学研究,在多种实体瘤中评估由3种实验性药物组成的2种组合疗法的疗效和安全性。

该项研究将评估阿斯利康的抗PD-L1抗体MEDI4736与协和发酵麒麟抗CCR4抗体mogamulizumab组合疗法,以及阿斯利康抗CTLA-4抗体tremelimumab和mogamulizumab组合疗法。

MEDI4736、tremelimumab、mogamulizumab均为癌症免疫疗法,这是一类新的疗法,旨在利用人体自身的免疫系统来帮助对抗癌症。MEDI4736和tremelimumab能够阻断帮助肿瘤逃避免疫检查的信号通路,而mogamulizumab则能够抑制帮助肿瘤屏蔽免疫系统的某些免疫细胞。

根据协议,阿斯利康和协和发酵麒麟将共同资助该项研究,但由协和发酵麒麟开展研究。该研究的I期部分,预计将建立一种推荐的剂量方案,Ib期研究将评估这2种组合疗法的疗效和安全性,相关数据将用于确定是否进行进一步的临床开发。

目前,阿斯利康和MedImmune正在开展一项广泛的免疫肿瘤学联合疗法临床试验项目,包括MEDI4736与Incyte口服吲哚胺双加氧酶-1(IDO1)抑制剂INCB24360组合疗法,以及MEDI4736与Advaxis免疫疫苗ADXS-HPV的组合疗法。(生物谷Bioon.com)

英文原文:AstraZeneca and Kyowa Hakko Kirin partner on immuno-oncology clinical study

Wednesday, 30 July 2014

AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.

The study will evaluate AstraZeneca’s anti-PD-L1 antibody, MEDI4736, in combination with Kyowa Hakko Kirin’s anti-CCR4 antibody, mogamulizumab, and AstraZeneca’s anti-CTLA-4 antibody tremelimumab, in combination with mogamulizumab.

MEDI4736, tremelimumab, and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which use the body's own immune system to help fight cancer. MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.

Under the terms of the agreement, AstraZeneca and Kyowa Hakko Kirin will co-fund the study, which will be conducted by Kyowa Hakko Kirin. The Phase I part of the study is expected to establish a recommended dose regimen and Phase Ib will assess the safety and efficacy of the two combinations. Results from these studies will determine the future clinical development of the combinations.

Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “We believe that combination therapy in immuno-oncology has the potential to be one of the most effective ways of treating cancer. Our partnership with Kyowa Hakko Kirin provides the opportunity to explore two novel and exciting combinations.”

“With recent progress in the field of cancer immunotherapy, we have the potential to bring significant benefits to patients,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “Given the potential synergistic activity of our anti-CCR4 antibody when combined with immune checkpoint inhibitors, we look forward to collaborating with AstraZeneca to explore these combinations in multiple types of cancer.”

AstraZeneca and MedImmune have a broad programme of immuno-oncology combination trials underway, including MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360 and MEDI4736 with Advaxis’ immunotherapy vaccine, ADXS-HPV.
 

NOTES TO EDITORS

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 (IMTs), to empower the patient’s immune system and attack the cancer.

About tremelimumab

Tremelimumab is an investigational, fully human monoclonal IgG2 antibody which binds to the protein CTLA-4, expressed on the surface of activated T cells. It is one of the only molecules in development for treating mesothelioma by blocking CTLA-4 to strengthen immune system response.

About mogamulizumab

Mogamulizumab is a novel, humanised monoclonal antibody directed against CC chemokine receptor 4. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorisation for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014. Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.

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