Novartis Inks $840 Million Collaboration and Option Deal with IFM Due

诺华与IFM Due签署价值8.4亿美元合作及期权交易,开发免疫疗法

2019-09-06 17:31:20 BioSpace

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IFM Therapeutics announced that one of its subsidiaries, IFM Due (pronounced doo-way), had inked a collaboration and option deal with Novartis. The companies will develop a group of immunotherapies that inhibit the cGAS/STING pathway to treat a broad range of inflammatory and autoimmune diseases. Under the terms of the deal, Novartis will make payments to fully cover IFM Due’s research and development costs. In return, it will have the option to acquire IFM Due. If Novartis exercises the option, IFM Due’s shareholders will be entitled to up to $840 million in aggregate value including an upfront payment. “IFM was founded to address novel targets of the innate immune system that are believed to underlie numerous serious conditions,” stated Gary D. Glick, co-founder and chief executive officer of IFM. “In the four years since, we have developed an array of distinct small molecules for inflammatory disorders and cancer that are now in clinical development, demonstrating our team’s ability to progress novel, high-value programs rapidly. Today’s announcement represents a significant milestone in the continued advancement of our pipeline.” The cGAS/STING pathway is involved in inflammatory responses. Mutations that activate the pathway are implicated in several serious autoinflammatory and autoimmune diseases, including rare diseases like Aicardi-Goutieres syndrome (AGS), STING-associated vasculopathy with onset in infancy (SAVI) and a subgroup of systemic lupus erythematosus (SLE). It is also connected to more common diseases like nonalcoholic steatohepatitis (NASH), chronic obstructive pulmonary disease (COPD), age-related macular degeneration (AMD) and Parkinson’s disease. In April, Novartis acquired another IFM Therapeutics subsidiary, IFM Tre. Novartis paid $310 million up front with another $1.265 billion in various milestones. IFM Tre launched in July 2018 and focuses on NLRP3 antagonists for inflammatory diseases. As part of that deal, Novartis picked up all rights to IFM Tre’s portfolio of NLPR3 antagonists, which included one clinical and two preclinical programs. IFM-2427 is the clinical stage project, which is being developed for atherosclerosis and NASH. One preclinical program is for inflammatory bowel disease and the other is a central nervous system (CNS)-penetrant molecule. “IFM Tre’s compounds have demonstrated that they can fine-tune the immune system, offering a potentially potent approach for treating a large variety of diseases associated with inflammation,” stated Jay Bradner, president of the Novartis Institutes for BioMedical Research. In light of the data-manipulation scandal around Novartis and its gene therapy Zolgensma for spinal muscular atrophy (SMA), the question has been raised if Novartis is leery of the data related to products in these acquisitions and deals. Although it did not apparently affect the outcomes of the Zolgensma approval or undermine its efficacy or safety, the U.S. Food and Drug Administration (FDA) indicated that some of the preclinical data submitted by AveXis, a Novartis subsidiary, had been manipulated. The short answer is that Novartis trusts the data. “The challenge is always, do we trust the team?” Prakash Raman, global head of business development and licensing for the Novartis Institutes for Biomedical Research, told the Boston Business Journal. “There are a few people from Novartis at IFM, so we felt comfortable with the team, and the rigor of testing we expect is in line with what they expect. We’re always partnering. It’s much easier to address some issues earlier than later.”
IFM Therapeutics宣布,其子公司之一IFM Due(发音为Doo Way)与诺华签署了合作和期权交易。这些公司将开发一组抑制cgas/sting途径的免疫疗法,以治疗广泛的炎症和自身免疫性疾病。 根据协议条款,诺华将支付全部IFM Due的研发费用。作为回报,它将有权选择收购到期的ifm。如果诺华行使期权,ifm due的股东将有权获得高达8.4亿美元的总价值,包括预付款。 ifm的联合创始人兼首席执行官加里d格利克(gary d.glick)表示:“ifm的成立是为了解决先天免疫系统的新目标,这些新目标被认为是许多严重疾病的基础。”“在此后的四年中,我们开发了一系列独特的小分子药物,用于治疗炎症性疾病和癌症,这些药物目前正处于临床开发阶段,这表明我们的团队有能力快速开发新的高价值项目。今天的宣布标志着我们管道继续向前推进的一个重要里程碑。” cgas/sting通路参与炎症反应。激活该通路的突变与一些严重的自身炎症和自身免疫性疾病有关,包括罕见的疾病,如爱卡第痛风综合征(ags)、婴儿期发病的针刺相关血管病(savi)和系统性红斑狼疮(sle)的一个亚组。它还与非酒精性脂肪性肝炎(nash)、慢性阻塞性肺病(copd)、老年性黄斑变性(amd)和帕金森病等更常见的疾病有关。 今年4月,诺华收购了另一家ifm治疗子公司ifm tre。诺华预付了3.1亿美元,在多个里程碑上又支付了12.65亿美元。IFM TRE于2018年7月推出,专注于NLRP3拮抗剂治疗炎症性疾病。 作为交易的一部分,诺华获得了ifm tre的nlpr3拮抗剂组合的所有权利,其中包括一个临床和两个临床前项目。ifm-2427是针对动脉粥样硬化和nash的临床分期项目。一种是治疗炎症性肠病,另一种是中枢神经系统渗透分子。 诺华生物医学研究院院长杰伊·布拉德纳说:“ifm-tre的化合物已经证明,它们可以微调免疫系统,为治疗与炎症相关的多种疾病提供了潜在的有效途径。” 鉴于诺华的数据操纵丑闻及其脊髓性肌萎缩症(SMA)的基因治疗唑根瘤,有人提出诺华是否对这些收购和交易中的产品相关数据持怀疑态度。尽管它并没有明显影响佐根瘤批准的结果,也没有破坏其疗效或安全性,但美国食品和药物管理局(fda)表示,诺华子公司avexis提交的一些临床前数据是被操纵的。 简而言之,诺华相信这些数据。 “挑战总是存在的,我们是否信任团队?诺华生物医学研究院(novartis institutes for biomedical research)业务发展和许可全球主管普拉卡什•拉曼(prakash raman)对《波士顿商业日报》表示。“IFM有几个来自诺华的人,所以我们对团队感到很满意,我们期望的严格测试符合他们的期望。我们一直是搭档。提前解决一些问题要容易得多。”

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