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一加一大于二 默沙东联手Syndax开发突破性肿瘤药物联合疗法

  1. entinostat
  2. Keytruda
  3. PD-1
  4. Syndax
  5. 默沙东

来源:生物谷 2015-04-01 11:25

最近,默沙东公司宣布将和位于美国麻省沃尔瑟姆的小型生物医药公司Syndax进行合作开发肿瘤联合疗法。

2015年4月1日讯 /生物谷BIOON/ --最近,默沙东公司宣布将和位于美国麻省沃尔瑟姆的小型生物医药公司Syndax进行合作开发肿瘤联合疗法。能被制药巨头默沙东选为合作伙伴,Syndax公司可并不是浪得虚名。事实上,Syndax公司是FDA自2013年开始进行突破性药物认证以来第一批获此殊荣的公司。公司开发的entinostat是一种脱乙酰化酶抑制剂药物,目前正处于治疗抗药性绝经期妇女乳腺癌相关的临床三期研究。

FDA此前已经表示如果entinostat能够在无进展生存期方面实现突破,FDA将对其采取有限审批的措施。这也可见FDA对entinostat的期望之深。

此次默沙东希望结合公司新近上市的PD-1药物Keytruda和entinostat联合治疗非细小细胞肺癌和黑色素瘤。这一协议也被认为是公司大力推广Keytruda计划的一部分。

随着肿瘤免疫疗法市场的持续火爆,PD-1药物领域的研究更加趋于白热化。默沙东、百时美施贵宝、阿斯利康、罗氏均在推进各自的临床项目,同时广泛合作深度挖掘各自免疫疗法的临床潜力。

就在近日,百时美与Bavarian Nordic签署高达10亿美元协议,合作开发癌症免疫鸡尾酒。就在不久之前,默沙东还与日本药企卫材(Eisai)宣布了一项战略合作开展多个临床试验,评估其PD-1免疫疗法Keytruda(pembrolizumab)与卫材肿瘤学药物Lenvima(lenvatinib)和Halaven(eribulin)组合疗法的疗效和安全性。(相关阅读:默沙东牵手卫材深度挖掘PD-1免疫疗法Keytruda临床潜力)双方已计划开展的研究包括:一项Ib/II研究将调查Keytruda+Lenvima组合疗法用于特定实体瘤;一项Ib/II研究评估Keytruda+Halaven用于三阴乳腺癌(TNBC)。(生物谷Bioon.com)

详细英文报道:

Are two breakthrough cancer drugs better than one? Pharma giant Merck ($MRK) and Waltham, MA-basedSyndax plan to find out in a Phase Ib/II study matching the tiny biotech's entinostat with Keytruda, Merck's big anti-PD-1 therapy, for either non-small cell lung cancer or melanoma. Investigators plan to start recruiting for the study in the second half of this year.

Syndax was one of the chosen few among the little biotechs to gain a breakthrough drug designation for a cancer drug, joining the first wave of BTDs back in 2013 for an experimental histone deacetylase (HDAC) inhibitor now in Phase III testing in treatment-resistant postmenopausal women with metastatic ER-positive breast cancer. The FDA issued the designation--which offers a potentially shorter path to an approval--after reviewing promising progression-free survival and overall survival data racked up in Phase II.

This latest immuno-oncology collaboration follows a lengthy string of pacts inked by Merck, which sees its PD-1 drug as a natural combo for a wide range of targeted drugs. Keytruda works by dismantling a natural cloaking device cancer cells use to stay hidden from the immune system. And Merck has been close behind Bristol-Myers, the leader in the field with Opdivo, an IO drug recently approved to treat lung cancer.

Syndax tried to capitalize on its BTD win at the FDA with an IPO last year, but later threw in the towel on the offering and inked a $100 million licensing deal with Kyowa Hakko Kirin in January, which included a $25 million upfront payment for rights to the Japanese and Korean markets. Syndax CEO Arlene Morris toldXconomy's Ben Fiedler a few weeks ago that the biotech decided to steer clear of the IPO market for now after determining the drug's potential in an immuno-oncology combo, hinting about the Merck deal then in the works.

But no one is offering up telltale financial details, including who's paying for the new study, which could pave the way to a pivotal late-stage trial.

Syndax is a 2007 Fierce 15 company. The biotech has been financed by Domain Associates, which brought in their Russian partners at RusnanoMedInvest on a syndicate that also includes MPM Capital and Forward Ventures. Domain founded the company with technology developed at the Salk Institute

"The broad base of clinical data involving our anti-PD-1 therapy, Keytruda, continues to provide a strong foundation for advancing the study of different novel combination regimens," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories.

 

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