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阿斯利康和Advaxis合作开发免疫肿瘤学组合疗法

发布日期:2014-07-23 10:02来源:生物谷作者:佚名点击量:

阿斯利康与Advaxis达成合作,启动I/II期临床研究,评价2种免疫疗法(MEDI4736和ADXS-HPV)的组合疗法用于HPV相关宫颈癌和头颈癌的治疗。

阿斯利康和Advaxis合作开发免疫肿瘤学组合疗法

2014年7月23日讯 /生物谷BIOON/ --阿斯利康(AZN)7月22日宣布,旗下全球生物制剂研发部门MedImmune公司已与美国生物技术公司Advaxis达成一项临床试验合作,启动一项I/II期免疫治疗研究,评估MedImmune公司实验性抗PD-L1免疫检查点抑制剂MEDI4736和Advaxis先导癌症免疫疫苗ADXS-HPV组合疗法用于晚期复发性或顽固性人乳头瘤病毒(HPV)相关宫颈癌和HPV相关头颈癌治疗的疗效和安全性。

MEDI4736和ADXS-HPV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旨在通过阻断可帮助肿瘤逃避侦查的信号通路,来对抗肿瘤的免疫逃避战术;而ADXS-HPV能够增强免疫细胞对抗肿瘤的能力。临床前证据表明,ADXS-HPV和免疫检查点抑制剂(如MEDI4736)的组合疗法可增强整体的抗肿瘤应答。

根据协议条款,MedImmune和Advaxis将评估MEDI4736+ADXS-HPV组合疗法用于HPV相关宫颈癌和头颈部鳞状细胞癌的治疗。试验的I期部分,预计将确定组合疗法的推荐剂量方案,II期部分将评估组合疗法的疗效和安全性,所获得的研究结果将用于确定是否有必要将该组合疗法推进至进一步的临床开发。

最近,阿斯利康和MedImmune已启动了其他免疫肿瘤学组合疗法的临床试验,包括与生物制药公司Incyte的一项合作,该合作旨在调查MEDI4736和口服吲哚胺双加氧酶-1(IDO1)抑制剂INCB24360组合疗法的疗效。(生物谷Bioon.com)

英文原文:MedImmune and Advaxis partner on immuno-oncology combination clinical trial

Tuesday, 22 July 2014

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’ lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.

Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. MEDI4736 is designed to counter the tumour’s immune-evading tactics by blocking a signal that helps tumours avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumour. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumour response.

“Our collaboration with Advaxis is further evidence of MedImmune’s commitment to explore novel combination approaches as we progress our immuno-oncology portfolio,” said Dr. Bahija Jallal, Executive Vice President, MedImmune. “We believe there could be an important clinical benefit from the combination of MEDI4736 with Advaxis’s antigen-specific cancer vaccine.”

Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted.

Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.

“We are excited to be partnering with MedImmune and evaluating MEDI4736 in combination with our immunotherapy,” said Daniel J. O’Connor, Chief Executive Officer, Advaxis. “This is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies. As multiple companies vie for a competitive advantage in the future PD-L1 market, the ability of our immunotherapy platform to attack multiple tumour targets makes it an attractive combination therapy.”

AstraZeneca and MedImmune have recently initiated other immuno-oncology combination trials, including a collaboration with biopharmaceutical company Incyte to study MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. 

NOTES TO EDITORS

About HPV-associated head and neck cancers

The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the WHO, approximately 15-20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the US.

About cervical cancer

There are 500,000 new cases of cervical cancer caused by HPV worldwide every year, according to the WHO Human Papillomavirus and Related Cancers, World Summary Report 2010. Current preventative vaccines cannot protect the 20 million women who are already infected with HPV, and of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines. Challenges with acceptance, accessibility, and compliance have resulted in only a third of young women being vaccinated in the US and even less in other countries around the world. HPV is associated with 20-50 percent of oral squamous cell carcinomas.

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.

About ADXS-HPV

ADXS-HPV is Advaxis’s lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer and anal cancer. In cervical cancer, a recently completed Phase 2 study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy, which warrants further development of the molecule. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform that redirects the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only cancer immunotherapy shown to actively suppress Tregs and MSDCs are key components in the cancer microenvironment that contribute to tumour growth and protect it from immunologic attack.

In addition to ADXS-HPV, Advaxis’s second immunotherapy candidate, ADXS-cHER2, targets the HER2 receptor, which is overexpressed in certain solid-tumour cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, a model for human bone cancer. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other immunotherapy constructs to a major animal-health company. For more information, please visit www.advaxis.com.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.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