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Aduro癌症免疫鸡尾酒疗法获得FDA突破性药物认证

2014-07-22 生物谷 生物谷

FDA胰腺癌癌症免疫鸡尾酒疗法
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Aduro BioTech生物技术公司最近如愿以偿的收获了FDA对其开发的用于治疗胰腺癌的癌症免疫鸡尾酒疗法的突破性药物地位认证。FDA做出这一决定主要是基于这种疗法出色的临床二期数据。Aduro公司的这一疗法是将CRS-207和GVAX两种药物结合在一起。这两种药物都分别能够激活人体的免疫系统，并靶向杀灭肿瘤细胞。在临床二期研究中，接受鸡尾酒疗法的患者生存期为6.1个月，明显优于GVAX的3

强生（JNJ）合作伙伴Aduro生物科技公司7月21日宣布，FDA已授予胰腺癌CRS- 207和GVAX Pancreas免疫组合疗法突破性疗法认定。该组合疗法突破性疗法认定的授予，是基于在转移性胰腺癌患者中开展的一项II期临床试验的数据，数据表明， 与GVAX Pancreas疫苗组（Arm A）相比，GVAX Pancreas + CRS-207联合疫苗组表现出统计学意义的显著生存利益（平均总生存期：6.1个月 vs 3.9个月，p=0.0172）。

目前，Aduro正在开展一项扩展IIb期临床试验（ECLIPSE），该项研究在240例转移性胰腺癌患者中开展，评估GVAX Pancreas + CRS-207组合疗法的疗效、免疫反应和安全性。主要终点是总生存期（OS）。

CRS-207是Aduro公司基于活的减毒、双删除（LADD）李斯特菌免疫治疗平台开发的候选产品家族中的一员，能够诱导强劲的天然和T细胞介 导的免疫反应。CRS-207已被改造称能够表达肿瘤相关抗原间皮素（mesothelin），该蛋白在许多肿瘤中过度表达，包括间皮瘤和胰腺癌、非小细 胞肺癌、卵巢癌和胃癌。

GVAX Pancreas是衍生于人类癌细胞系的GVAX疫苗家族中的一员，这些细胞系已被遗传改造可分泌粒细胞-巨噬细胞集落刺激因子（GM-CSF），这是一种免疫调节细胞因子。GVAX Pancreas也能够表达间皮素。

在2个单独的交易中，强生旗下杨森研发单元已与Aduro签署协议，利用该公司的李斯特菌免疫疗法开发平台生产一些候选产品，同时授权获得GVAX技术用于胰腺癌的治疗。这些协议有望为Aduro公司带来高达3.65亿美元的收入。

FDA 做出这一决定主要是基于这种疗法出色的临床二期数据。Aduro公司的这一疗法是将CRS-207和GVAX两种药物结合在一起。这两种药物都分别能够激 活人体的免疫系统，并靶向杀灭肿瘤细胞。在临床二期研究中，接受鸡尾酒疗法的患者生存期为6.1个月，明显优于GVAX的3.9个月。公司目前正在着手进 行这种鸡尾酒疗法的第二次临床二期研究，以进一步对比这种鸡尾酒疗法和两种单独药物治疗之间的差异。Aduro公司希望在2016年完成这一研究。

关于LADD和GVAX技术，详见Aduro公司网站：http://www.adurobiotech.com/（生物谷Bioon.com）

详细英文报道：

Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.

An FDA breakthrough tag entitles Aduro to a speedy review and access to senior agency staff as it works through the regulatory process with CRS-207 and GVAX, two immunotherapies designed to battle pancreatic cancer in tandem.

The regulatory victory comes on the heels of positive Phase II data for the combination, in which Aduro's cocktail beat out GVAX alone in 93 patients with metastatic pancreatic cancer. Median overall survival on the combo came in at 6.1 months, a statistically significant improvement over GVAX's 3.9 months.

Now Aduro is working through an expanded Phase IIb trial, enrolling about 240 patients into three treatment arms: one receiving the combination treatment, one taking CRS-207 alone and another on standard chemotherapy. The study's primary endpoint is overall survival, and Aduro hopes it'll back up the safety, immune response and efficacy CRS-207 and GVAX have demonstrated thus far.

The biotech expects to complete enrollment in that trial by the end of next year with an estimated completion date of December 2016. And with the FDA's promise of special attention, Aduro is optimistic about the future for its oncology combo, CEO Stephen Isaacs said.

"This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat," Isaacs said in a statement.

And thanks to Johnson & Johnson ($JNJ), Morningside and some undisclosed investors, Aduro has $55 million in fresh venture cash to follow through on its clinical ambitions. After closing its C round in June, the 40-employee biotech has raised about $84 million since its foundation.

CRS-207 is a treatment derived from live Listeria monocytogenes bacteria, engineered to express the tumor-associated antigen mesothelin which spurs the immune system to deploy T cells and attack cancer. GVAX, originally developed by BioSante, failed in its own right as a standalone cancer vaccine back in 2008 but has found new life as partner to CRS-207.

J&J's interest in Aduro goes beyond venture capital. In two separate deals, the pharma giant's Janssen R&D unit signed on to use the biotech's Listeria-based immunotherapy development platform to churn out some candidates of its own and licensed the GVAX technology for prostate cancer. Those agreements could bring in as much $365 million for Aduro.

Behind the lead program, Aduro is working through Phase I study with a combination of CRS-207 and chemotherapy to treat mesothelioma, and the company has completed preclinical work on ADU-214 for ovarian and non-small cell lung cancers.

In total, the FDA has handed out 59 breakthrough therapy designations, but Aduro's combo becomes just the 5th treatment given the tag by the agency's biologics arm, according to the FDA. The small-molecule-focused Center for Drug Evaluation and Research accounts for the rest

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