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[新药快讯] 诺华与牛津生物医药扩大CAR-T研发合作 领跑CAR-T领域

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朵朵7 发表于 2014-10-15 19:30:14 | 只看该作者 回帖奖励 |倒序浏览 |阅读模式

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诺华与牛津生物医药扩大CAR-T研发合作 领跑CAR-T领域

                               
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发布日期:2014-10-15  来源:生物谷  浏览次数:0

CAR-T肿瘤免疫治疗领域,诺华处于领先地位,FDA已授予CTL019突破性疗法,近来,诺华不断加大投资力度,进一步拉大在CAR-T领域的领先优势。


嵌合抗原受体-T细胞(CAR-T)疗法代表着当今最先进的肿瘤免疫细胞治疗技术,在相关临床试验中取得了巨大的成功,该领域已成为药品研发最热门的领域之一,也是投资合作的大热点。

目前,诺华(Novartis)在CAR-T领域处于领先地位,其主要对手为生物技术领域最热门的初创公司Juno Therapeutics,其他跟进者包括凯特药业(Kite Pharma)、基因治疗先驱蓝鸟生物(Bluebird bio)、生物技术巨头新基(Celgene),辉瑞今年6月与Cellectis公司签署29亿美元协议进入CAR-T领域,而蓝鸟生物在今年7月收购了另一家生物制药公司Pregenen,该公司由CAR-T领域的一些科学先驱者联合成立,该笔收购意在进一步奠定该公司在CAR-T领域的地位。

近日,诺华进一步加大CAR-T领域投资,与英国牛津生物医药(Oxford BioMedica)签署一笔9000万美元的合作协议,进一步扩大双方在CAR-T领域的合作。根据协议,诺华将支付一笔1400万美元的前期付款,获得将Oxford慢病毒载体LentiVector应用于CAR-T免疫疗法CTL019的非独家全球开发和商业化权利。此外,诺华还承诺会对Oxford进行股权投资以及支付未来销售相关的款项。Oxford将负责生产表达CTL019/CART-019的慢病毒载体,该生产合作为期3年。此外,Oxford已授予诺华此次合作所开发的全部CAR-T产品的全球开发和商业化独家权利。


                               
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嵌合抗原受体T细胞疗法(CAR-T)是应用患者自体T细胞的个性化治疗方法,患者的T细胞通过基因工程修饰,加上一个嵌合蛋白,经过体外扩增后输至病人体内。经过嵌合蛋白修饰的T细胞识别攻击带有特定抗原的肿瘤细胞并引发免疫反应从而达到治疗效果。

目前,诺华在CAR-T免疫疗法领域处于领先地位,其临床试验中有用于白血病、淋巴瘤、间皮瘤和胰腺癌的实验性产品。今年7月,FDA已授予诺华CAR-T免疫疗法CTL019突破性疗法认定,这意味着该疗法在相关临床研究中的出色表现获得了FDA的肯定,而FDA在今后的审查中也会给予相应的便利。截至目前,诺华凭借出色的研发,已赢得FDA 5个突破性疗法认定,在业界首屈一指。

此前,今年9月,诺华投资2000万美元,在美国宾夕法尼亚州费城建立一个专门负责开发CAR-T疗法的研发中心,加速CTL019相关项目的研发进度,该CAR-T研发中心预计2016年投入使用。


英文原文:Novartis taps Oxford BioMedica in $90M immuno-oncology deal

Oxford, UK – 10 October 2014: Oxford BioMedica plc (LSE: OXB), ("OXB" or "the Group") a leading gene and cell therapy company, announces today that it has signed further contracts with Novartis which build on the collaboration with Novartis announced in May 2013.

Under the terms of the new agreement, Novartis will pay $14 million upfront including a $4.3 million equity subscription for a non-exclusive worldwide development and commercialisation licence in oncology under the Group's LentiVector® platform. OXB will manufacture lentiviral vectors expressing CTL019/CART-019. The manufacturing contract has an initial three year term. Additionally, OXB has granted Novartis an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products arising from the process development collaboration.

According to the terms of the deal, OXB is eligible to receive up to $90 million from Novartis over the next three years. This amount includes the upfront licence payment, the equity investment, manufacturing and process development services and various performance incentives. The equity investment comprises 70,807,500 ordinary shares at 3.8p, the average middle market price for the 10 business days prior to 7 October 2014. OXB will also receive undisclosed royalties on potential future sales of CTL019 and other CAR T cell products covered by the agreement.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said:

"We are delighted to sign a second agreement with Novartis. Oxford BioMedica now has a breadth of leading capabilities in gene and cell therapy under-pinned by a dominant LentiVector® patent estate (licensed to multiple companies), and a state-of-the-art GMP manufacturing facility.  Today's commitment from Novartis, including their equity investment, strongly endorses this.  Our team has demonstrated its ability to solve complex gene and cell therapy manufacturing challenges, and to develop the state-of-the-art analytics essential for such programmes.

"Oxford BioMedica aims to help facilitate access to life changing treatments for many more patients with a variety of clinical indications and is now strongly positioned to deliver significant value-creating results against its strong asset base."




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feibing 发表于 2014-10-15 20:07:16 | 只看该作者
谢谢分享,楼主辛苦
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ericzhang 发表于 2014-10-16 15:50:36 | 只看该作者
谢谢分享啊
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