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AbbVie与Ablynx达成8.4亿美元纳米抗体合作协议

  1. AbbVie
  2. Ablynx
  3. ALX-0061
  4. IL-6
  5. 类风湿性关节炎
  6. 纳米抗体

来源:生物谷 2013-11-29 19:44

2013年9月23日讯 /生物谷BIOON/ --AbbVie与Ablynx制药宣布,双方已达成了一项全球性许可协议,开发和商业化抗IL-6R纳米抗体ALX-0061,用于炎症性疾病的治疗。

2013年9月23日讯 /生物谷BIOON/ --AbbVie与Ablynx制药宣布,双方已达成了一项全球性许可协议,开发和商业化抗IL-6R纳米抗体ALX-0061,用于炎症性疾病的治疗。

ALX-0061是Ablynx专有的抗IL-6R纳米抗体,已于2013年2月成功完成IIa期临床试验,该试验在中度至重度活动性类风湿性关节炎(RA)患者中开展,研究中,ALX-0061表现出了强大的疗效和安全性数据。

根据协议条款,Ablynx将负责完成ALX-0061在类风湿性关节炎(RA)和系统性红斑狼疮(SLE)中的II期临床开发。在达到既定的成功标准后,AbbVie将行使对ALX-0061的许可权利,同时将负责后续的III期临床开发和商业化。Ablynx将保留在比利时、荷兰、卢森堡的联合销售权。

Ablynx将获得一笔1.75亿美元的预付款,在实现开发、监管、商业化、销售里程碑后,还将获得高达6.65亿美元的里程碑款项,以及产品在未来净销售额达2位数的特许权使用费。

ALX-0061是一种纳米抗体,通过IL-6受体(IL-6R)靶向白介素6(IL-6)信号通路,该受体在RA炎症过程中起着关键作用。ALX-0061已被认为是同类产品中最佳的抗体疗法,大小仅为26kD,这使得ALX-0061能够更有效地渗透进组织。这种强效的、单价结合作用,能够有效地降低潜在的脱靶效应。ALX-0061对可溶性IL-6R具有很强的亲和力,能够确保快速的靶标攻击,并可能导致快速起效,同时具有非常低的免疫原性。

关于Ablynx公司

Ablynx公司是一家生物制药公司,从事纳米抗体的发现和开发,这是一种新颖的治疗性蛋白,基于单结构域的抗体片段,可开发用于一系列重大疾病的治疗,如炎症性疾病、血液病、肿瘤学及肺部疾病。目前,Ablynx公司管线中有25个纳米抗体项目,7个纳米抗体处于临床开发阶段。Ablynx公司已与多个制药巨头达成了研究合作及伙伴关系,包括勃林格殷格翰、默克雪兰诺、诺华、默沙东。(生物谷Bioon.com)

英文原文:Abynx and AbbVie sign deal over rheumatoid arthritis nanobody

GHENT, Belgium and NORTH CHICAGO, Ill., Sept. 23, 2013 /PRNewswire/ -- Ablynx [Euronext Brussels: ABLX] and AbbVie [NYSE: ABBV] today announced that they have entered into a global license agreement to develop and commercialize the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases.  ALX-0061 is Ablynx's proprietary anti-IL-6R Nanobody that successfully completed a Phase IIa study in February 2013 reporting strong efficacy and safety data in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.

Under the terms of the agreement, Ablynx will be responsible for completing Phase II clinical development in both RA and systemic lupus erythematosus (SLE).  Upon the achievement of pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialization.  Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg.  Ablynx will receive an upfront payment of $175 million, which will partly be used to fund the next phases of clinical development of ALX-0061.  Upon achievement of certain development, regulatory, commercial and sales-based milestones, Ablynx will be eligible to receive additional milestone payments totalling up to $665 million as well as double-digit tiered royalties on net sales upon commercialization.

"This deal represents a major milestone for Ablynx and confirms both the potential value of ALX-0061 and the ability of our Nanobody technology to generate clinical candidates with very exciting potential," said Edwin Moses, Ph.D., chairman and chief executive officer, Ablynx.  "It also demonstrates that we are delivering on our business model of strategic partnering for the development and commercialization of selected programs within our pipeline.  We truly believe that AbbVie's significant expertise in rheumatology aligns us with the ideal partner to further progress the development of ALX-0061 and to ensure we maximize the potential of this asset."

Dr. Moses added, "the combined clinical expertise of AbbVie and Ablynx will allow us to progress with the rapid development of ALX-0061, with the current plan being the initiation of various clinical trials in both RA and SLE during the course of 2014 and 2015.  We look forward to working together with AbbVie to potentially develop a successful therapy for patients suffering from chronic inflammatory conditions and to making a real difference to the quality of their lives."

"This agreement is further evidence of AbbVie's commitment to pursue novel treatment options for autoimmune diseases," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie.  "Anti-IL-6 antibodies are a proven mechanism of action for autoimmune diseases and ALX-0061 has shown potential in a Phase IIa clinical trial in RA.  We are looking forward to working with Ablynx to develop a potentially new and effective therapy for patients suffering from serious chronic conditions such as RA and SLE."

About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA.  ALX-0061 has been designed to become a best-in-class therapeutic.  Its small size (26kD) may potentially allow ALX-0061 to penetrate more effectively into tissues.  The potent, monovalent interaction of the molecule with its target reduces the possibility of off-target effects.  Its binding to human serum albumin prolongs the in vivo half-life of the product and can lead to improved trafficking to areas of inflammation.  The Nanobody has a very strong affinity for soluble IL-6R which should ensure fast target engagement and could result in a fast onset of effect.  ALX-0061 appears to benefit from the general Nanobody characteristic of having a very low immunogenic potential.

About RA and SLE
RA is characterized by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage, which is further compounded by joint deformation.  The condition is associated with lower quality of life, premature death, disability, and unemployment.  It is estimated that up to 1 percent of the adult population worldwide suffer from RA.

SLE is a complex, multi-organ, autoimmune disorder characterized by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage. Although the etiology of SLE is not fully understood, multiple genetic, environmental, and hormonal factors have been implicated in its development.  The disease displays a broad variety of symptoms and highly variable clinical features, including systemic, cutaneous, renal, musculoskeletal, and haematological manifestations.  Approximately 5 million people worldwide suffer from a form of lupus and 90 percent of people diagnosed are women.

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