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百时美与小野制药在亚洲地区达成免疫肿瘤学战略合作

来源:生物谷 2014-07-24 16:52

2014年7月24日讯 /生物谷BIOON/ --百时美施贵宝(BMS)7月23日宣布,与日本小野制药(Ono Pharmaceutical)签署一项战略合作协议,联合开发和商业化数个免疫疗法作为单药疗法及组合疗法,以帮助解决日本、韩国、中国台湾等地区癌症患者未获满足的医疗需求。百时美和小野将共同开发和商业化Opdivo(nivolumab)和Yervoy(ipilimumab,易普利姆玛),开发以Opdivo为基础疗法的单药疗法和组合疗法,用于广泛类型的肿瘤。此次合作,将显著提升百时美免疫肿瘤学产品组合在全球范围内的潜在价值,尤其是亚洲地区。

Opdivo是一种PD-1免疫检查点抑制剂,已于7月初获日本批准,用于不可切除性黑色素瘤的治疗,该药是全球获批的首个PD-1免疫检查点抑制剂,目前正处于35项临床研究,开发用于多种类型肿瘤的治疗。Yervoy是一种CTLA-4免疫检查点抑制剂,已获中国台湾当局批准用于经治晚期黑色素瘤的治疗,在日本,该药已处于后期研发阶段,作为小细胞肺癌(SCLC)和非小细胞肺癌(NSCLC)的潜在治疗方案。

此外,该协议还包括了百时美免疫疗法管线中3个处于早期临床阶段的免疫肿瘤学资产:lirilumab,一种单克隆抗体,可阻断自然杀伤细胞上的KIR受体;urelumab,CD137共刺激受体的激动剂;BMS-986016,一种LAG3免疫检查点抑制剂。

关于Yervoy(ipilimumab):

Yervoy是一种重组人单克隆抗体,阻断细胞毒性T淋巴细胞相关抗原4(CTLA-4)。CTLA-4是一种T细胞活化的负调控因子,Yervoy与CTLA-4结合后,能阻断CTLA-4与其配体CD80/CD86的相互作用。阻断CTLA-4已被证明能够增强T细胞的活化和增殖。Yervoy在黑色素瘤患者中的疗效作用机制,是间接通过T细胞介导的抗肿瘤免疫反应。FDA于2011年3月批准Yervoy 3mg/kg单药疗法用于不能手术切除或转移性黑色素瘤患者的治疗,目前该药已获全球40多个国家批准。

关于Opdivo(nivolumab,BMS-936559):

癌细胞可能利用“调节子(regulator)”途径,如检查点(checkpoint)途径,逃避机体免疫系统,保护肿瘤免受免疫攻击。

Opdivo(nivolumab)是一种实验性、全人源化IgG4、抗程序性死亡受体1(PD-1)单克隆抗体,能够抑制PD-1与程序性死亡配体1(PD-L1/B7-H1)和程序性死亡配体2(PD-L2/B7-DC)的结合。阻断PD-1与其配体的相互作用,可能使T细胞恢复抗肿瘤免疫应答。目前,百时美施贵宝正调查nivolumab用于恶性黑色素瘤、肾癌、非小细胞肺癌及其他癌症的治疗。

nivolumab的开发项目研究总数超过25个:调查作为单药疗法或与其他药物联合用药,用于多个肿瘤类型的治疗,包括:非小细胞肺癌、小细胞肺癌、黑色素瘤、肾细胞癌、肝癌、血液癌症、三阴性乳腺癌、胃癌、胰腺癌。(生物谷Bioon.com)

英文原文:Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan

Companies to develop and commercialize Opdivo (nivolumab), Yervoy (ipilimumab), and three early–stage clinical immuno-oncology assets as single agents and combination regimens

Bristol-Myers Squibb gains access to Opdivo in Japan, South Korea and Taiwan, broadening company’s leadership in immuno-oncology

Ono strengthens its immuno-oncology portfolio with access to additional assets

Collaboration will leverage global clinical trials by including patients from Japan, South Korea and Taiwan

NEW YORK & OSAKA, Japan--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Ono Pharmaceutical Co., Ltd. (“Ono”) have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types.

Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is being developed in multiple tumor types in more than 35 clinical trials. Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan for the treatment of patients with advanced melanoma who have received prior therapy, and is in late-stage development as a potential treatment option for melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan. The agreement includes three additional early-stage clinical immuno-oncology assets from Bristol-Myers Squibb: lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor.

Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.

“Bristol-Myers Squibb’s collaboration with Ono supports our goal to maximize the full potential of our immuno-oncology portfolio for patients worldwide,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “This collaboration combines our leadership in immuno-oncology with both companies’ experience and capabilities in Asia, and strengthens our long-standing relationship with Ono.”

“Our collaboration with Bristol-Myers Squibb strengthens our ability to further enhance the potential of Opdivo, for which Ono recently received manufacturing and marketing approval in Japan as the first PD-1 inhibitor approved anywhere in the world,” said Gyo Sagara, President, Representative Director and CEO, Ono. “By pursuing the study of investigational combination regimens of immunotherapies with Bristol-Myers Squibb, we hope to bring a range of new therapeutic options to cancer patients.”

Under the terms of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize all collaboration products in Japan, South Korea and Taiwan. Development costs and commercial profits will be shared equally when Opdivo is used in combination with any Bristol-Myers Squibb compound (Yervoy, lirilumab, urelumab, BMS-986016). For a Bristol-Myers Squibb compound used as monotherapy, or two Bristol-Myers Squibb compounds used in a combination regimen, Bristol-Myers Squibb will fund the substantial majority of development costs and receive the substantial majority of commercial profits. When Opdivo is used as a single agent, Ono will fund the substantial majority of development costs and receive the substantial majority of commercial profits.

Prior to this announcement, Ono held exclusive rights to develop and commercialize Opdivo in Japan, South Korea and Taiwan while Bristol-Myers Squibb held such rights in the rest of the world, along with sole rights to develop and commercialize Yervoy, lirilumab, urelumab, and BMS-986016 worldwide. The trade name Opdivo has been proposed in the U.S. and other countries, but remains subject to health authority approval.

About Opdivo (nivolumab)

Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. The companies are investigating whether by blocking this pathway, Opdivo would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.

Opdivo was approved in Japan on July 4, 2014 for the treatment of patients with unresectable melanoma and is being studied in multiple tumor types in more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In May 2014, the FDA granted Opdivo Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.

About Yervoy (ipilimumab)

Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries, including Taiwan. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. This includes Phase 3 trials in prostate and lung cancers.

Yervoy (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION

Yervoy (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

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