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征服血癌不是梦:吉利德成功建立B细胞恶性肿瘤4个独特信号通路资产

  1. B细胞恶性肿瘤
  2. ONO-4089
  3. 吉利德
  4. 肿瘤学

来源:生物谷 2014-12-22 10:50

吉利德在3年时间匆匆建成肿瘤学部门,首个药物Zydelig成功拿下美欧市场。近日,吉利德将ONO-4089收入囊中,成功建立了针对B细胞恶性肿瘤的4个独特信号通路的产品线。

2014年12月22日讯 /生物谷BIOON/ --吉利德在艾滋病(HIV/AIDS)和丙肝(HCV)领域是绝对的领导者,该公司13年前将旗下肿瘤学部门售出,却在3年前肩负伟大使命重返肿瘤学领域,力求在10年内成为该领域的一支重要力量,其美好愿景是让癌症像艾滋病和丙肝那样得到有效管理。

过去3年,吉利德通过收购交易匆忙拼凑出了肿瘤学部门,首个肿瘤学药物Zydelig(idelalisib)就是2011年耗资6亿美元收购Calistoga公司获得,该药在今年接连拿下美欧2大市场,业界预测,Zydelig在2017年的销售额将突破15亿美元,使其当之无愧地成为吉利德肿瘤学管线中的一枚重磅明星药物;另一种抗癌药物momelotinib,则是2012年耗资5.1亿美元收购YM Biosciences公司获得,目前已处于III期临床,调查用于骨髓纤维化的治疗。此外,吉利德肿瘤学管线中还有另外2种新药,GS-9973和GS-5745,分别调查用于血液恶性肿瘤和多种实体瘤(包括胰腺癌)的治疗。

近日,吉利德再度发力,与日本药企小野制药(Ono Pharmacyclical)签署独家授权协议,获得了抗癌药物ONO-4059的开发和商业化权利。根据协议条款,吉利德将支付一笔前期款项及相关监管及商业化里程碑款项。吉利德将拥有ONO-4059在除日本、韩国、中国、东南亚国家联盟(ASEAN)以外国家和地区的开发和商业化独家权利。

成功建立针对B细胞恶性肿瘤4个独特信号通路的资产

通过此次合作,吉利德目前已拥有了靶向B细胞恶性肿瘤4个独特信号通路(PI3K delta,Syk,JAK,BTK)的化合物,包括Zydelig(PI3K delta抑制剂,已上市)、GS-9973(Syk抑制剂,I期临床)、momelotinib(JAK抑制剂,III期临床)、ONO-4089(BTK抑制剂)。

ONO-4059是一种选择性、口服布鲁顿酪氨酸激酶(BTK)抑制剂,开发用于B细胞恶性肿瘤及其他疾病,该药通过抑制肿瘤细胞复制和转移需要的布鲁顿酪氨酸激酶(BTK)而起到抗癌的作用。BTK是B细胞受体信号复合体中的一种关键信号分子,在恶性B细胞的生存及增殖中发挥关键作用。根据已公布的一项I期临床研究数据,ONO-4059针对慢性淋巴细胞白血病(CLL)和非霍奇金淋巴瘤(NHL)表现出了强大的疗效。

ONO-4059也是继强生已上市血癌药物Imbruvica(ibrutinib,销售峰值高达50亿美元)之后的又一个BTK抑制剂,有望成为白血病、淋巴瘤患者的新选择。吉利德和小野制药计划开发ONO-4059作为单药以及与其他已获批或实验性药物(包括吉利德自身管线中的激酶抑制剂)配伍,开发用于B细胞恶性肿瘤及其他疾病的治疗。吉利德表示,ONO-4059的加入,将为该公司提供一系列针对B细胞恶性肿瘤的极具潜力的组合疗法,有望带来更高更持久的癌症缓解。业界认为,其中最诱人的组合将是ONO-4059和Zydelig。(相关阅读:强生血癌药物Imbruvica在高风险CLL群体表现出强大治疗利益

除了收购和合作,吉利德也正在悄无声息的建立人才队伍。本月,吉利德成功将罗氏旗下基因泰克研发副总裁Philippe Bishop招至麾下,担任血液学和肿瘤学部门的高级副总裁。根据吉利德在艾滋病和丙肝领域的作为,业界认为,吉利德在肿瘤学领域必将大放异彩,让我们一起期待!(生物谷Bioon.com)

英文原文:Gilead buys into Ono's cancer drug as it scales up in oncology

Gilead Sciences ($GILD) is pushing further into oncology R&D, teaming up with Ono Pharmaceutical on a cancer treatment that could complement its first major success in the field.

The California drugmaker has agreed to pay an undisclosed sum for the ex-Asia rights to ONO-4059, an oral drug designed to treat B cell malignancies by blocking Bruton's tyrosine kinase, or BTK. The two companies will collaborate on the drug, currently in Phase I, and Gilead is on the line to hand out milestone payments tied to development, regulatory and commercial goals.

The treatment works by blocking an enzyme that is key to B cell growth, which spirals out of control in certain blood cancers. The treatment has demonstrated some preliminary promise in chronic lymphocytic leukemia and non-Hodgkin lymphoma, Ono said, and the partners plan to test it out both as a monotherapy and in combination with Gilead's other kinase inhibitors.

Perhaps most alluring is the prospect of pairing ONO-4059 with Gilead's idelalisib, a PI3K delta inhibitor approved as Zydelig earlier this year. The Big Biotech's growing oncology wing also boasts a ​JAK blocker in the Phase III momelotinib and the Phase I Syk inhibitor GS-9973, and adding Ono's drug gives Gilead a slew of mix-and-match options for B cell malignancies, Chief Scientific Officer Norbert Bischofberger said.

"In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead's other kinase inhibitors with a goal of achieving more pronounced and more durable response rates," Bischofberger said in a statement. "We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible."

After making its name in antivirals, Gilead is quietly working to build critical mass in oncology, this month recruiting Genentech veteran Philippe Bishop to take the lead as senior vice president of hematology and oncology therapeutics.

To date, the Gilead has largely relied on its checkbook to expand its cancer pipeline. Idelalisib arrived through the company's $600 million deal for Calistoga Pharmaceuticals in 2011, while momelotinib was the jewel of Gilead's $510 million buyout of YM Biosciences a year later. Beyond its kinase inhibitors, the company is developing the anti-cancer antibodies simtuzumab and GS-5745.

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