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Finch Therapeutics宣布获得9000万美元的融资,以推进口服微生物 [复制链接]

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发表于 2020-9-18 09:10 |只看该作者 |倒序浏览 |打印

Finch Therapeutics Announces $90 Million Financing to Advance Pipeline of Investigational Oral Microbiome Drugs

Proceeds to support the advancement of lead candidate through the final stages of clinical development for recurrent C. difficile infection, and the advancement into the clinic of programs for autism spectrum disorder and chronic hepatitis B
September 17, 2020 07:00 AM Eastern Daylight Time

SOMERVILLE, Mass.--(BUSINESS WIRE)--Finch Therapeutics Group, Inc. (“Finch”), a clinical-stage microbiome drug development company, announced today a $90 million Series D financing. New investors in the round include Baupost Group, Humboldt Fund, MSD Capital, MSD Partners, Octave Group, and OMX Ventures, along with support from existing investors, including Avenir Growth Capital, OCV Partners, Shumway Capital, SIG, SymBiosis, TPTF, and Willett Advisors.

    “The microbiome field is at an exciting inflection point, with recent positive data from our trial in recurrent C. difficile and other clinical data suggesting that microbiome drugs may become the next major therapeutic class to transform patient care.”
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“We are delighted to have the support of this strong syndicate to advance our platform and pipeline,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “The microbiome field is at an exciting inflection point, with recent positive clinical data from our trial in recurrent C. difficile and other clinical data suggesting that microbiome drugs may become the next major therapeutic class to transform patient care.”

“This additional funding positions us well for our next stage of development,” said Greg Perry, Chief Financial Officer of Finch Therapeutics. “In addition to advancing our lead candidate CP101 for recurrent C. difficile, we look forward to rapidly evaluating CP101 for the many other conditions linked to microbiome disruption, starting with a trial in chronic hepatitis B.”

Finch will use the proceeds from the financing to advance CP101 through the final stages of clinical development and regulatory submission in recurrent C. difficile infection (CDI), and to advance its platform and pipeline, including the initiation of Phase 1b studies evaluating FIN-211 for autism spectrum disorder (ASD) and CP101 for chronic hepatitis B (HBV).

“By starting their discovery process with insights mined from clinical data, Finch is pioneering a new and very promising approach to drug discovery,” said Nick Haft, Managing Director of OMX Ventures. “Recurrent C. difficile is only the tip of the iceberg, with dozens of proof-of-concept human microbiota transplantation studies demonstrating the potential of this approach for a wide variety of indications. With their platform, Finch is uniquely positioned to translate many of these exciting insights into promising new microbiome therapies.”

The financing builds on recent progress by Finch, with its lead candidate CP101, an investigational oral microbiome drug designed to deliver the full diversity of a healthy gut microbiome, meeting its primary efficacy endpoint for the prevention of recurrent CDI in a large, placebo-controlled trial earlier this year. Finch also recently announced the initiation of a program to evaluate CP101 for the treatment of chronic HBV, building off pre-clinical and clinical studies suggesting that delivery of a complete microbiome may drive viral clearance through stimulation of the innate immune response.1-4 Finch’s proprietary pipeline also includes FIN-211, an investigational oral microbiome drug initially targeting the treatment of children with ASD that suffer from serious gastrointestinal (GI) symptoms. FIN-211 is designed to re-establish a normal microbiome composition and function, building off pre-clinical and clinical studies suggesting that GI and behavioral symptoms may be linked to a disrupted microbiome.5-8 In partnership with Takeda Pharmaceuticals, Finch is also developing investigational oral microbiome drugs composed of rationally-selected strains designed to target specific mechanisms underlying the pathogenesis of inflammatory bowel disease. Finch’s first program with Takeda is focused on the development of FIN-524 for ulcerative colitis. After achieving key pre-clinical milestones with FIN-524, Finch and Takeda expanded their partnership to include the development of FIN-525 for Crohn’s disease.

About Finch Therapeutics

Finch Therapeutics is developing novel microbiome drugs to serve patients with serious unmet medical needs. Finch’s Human-First Discovery® platform enables reverse translation from clinical data to engineer the composition of the microbiome based on disease-modifying mechanisms. Finch’s platform uniquely enables development of both complete microbiome communities and rationally selected consortia to restore microbiome functionality and resolve conditions driven by dysbiosis, or disruption of the microbiome. Finch’s lead program, CP101, is an investigational microbiome drug with Fast Track and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile infection. The company is also developing FIN-211 for the treatment of children with autism spectrum disorder and CP101 for the treatment of chronic hepatitis B. The company has a strategic partnership with Takeda Pharmaceuticals focused on the development of microbiome drugs for inflammatory bowel diseases.

    Ren et al. Fecal microbiota transplantation induces hepatitis B virus e‐antigen (HBeAg) clearance in patients with positive HBeAg after long‐term antiviral therapy. Hepatology 2017.
    Xie et al. Faecal microbiota transplantation induced HBSAG decline in HBEAG negative chronic hepatitis B patients after long-term antiviral therapy. Gut 2018.
    Chauhan et al. Fecal microbiota transplantation in hepatitis b e antigen-positive chronic hepatitis b patients: a pilot study. Dig Dis Sci 2020.
    Chou et al. Age-related immune clearance of hepatitis B virus infection requires the establishment of gut microbiota. PNAS 2015.
    Kang et al. Microbiota transfer therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome 2017.
    Kang et al. Long-term benefit of microbiota transfer therapy on autism symptoms and gut microbiota. Scientific Reports 2019.
    Ning et al. Efficacy analysis of fecal microbiota transplantation in the treatment of 2010 patients with intestinal disorders. China J Gastrointest Surg 2019.
    Sgritta et al. Mechanisms underlying microbial-mediated changes in social behavior in mouse models of autism spectrum disorder. Neuron 2018.



Contacts

Media Contact:
Kathryn Morris
[email protected]
914-204-6412

Investor Contact:
Greg Perry
[email protected]

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发表于 2020-9-18 09:13 |只看该作者
Finch Therapeutics宣布获得9000万美元的融资,以推进口服微生物组研究药物的研发

继续支持主要候选药物在难治性梭状芽胞杆菌感染的临床开发最后阶段的发展,以及自闭症谱系障碍和慢性乙型肝炎计划进入临床的进展
2020年9月17日,东部夏令时间上午07:00

马萨诸塞州索默维尔-(美国商业资讯)-临床阶段微生物组药物开发公司Finch Therapeutics Group,Inc.(以下简称“ Finch”)今天宣布获得9000万美元的D轮融资。该轮的新投资者包括Baupost Group,Humboldt Fund,MSD Capital,MSD Partners,Octave Group和OMX Ventures,以及来自现有投资者的支持,包括Avenir Growth Capital,OCV Partners,Shumway Capital,SIG,SymBiosis,TPTF和威利特顾问。

    “微生物组领域正处于一个令人兴奋的转折点,最近我们在复发性艰难梭菌试验中获得的积极数据和其他临床数据表明,微生物组药物可能成为改变患者护理的下一个主要治疗类别。”
    推这个

Finch Therapeutics首席执行官Mark Smith博士说:“我们很高兴得到这个强大的组织的支持,以改善我们的平台和产品线。” “微生物组领域正处于一个令人兴奋的拐点,最近我们在复发性艰难梭菌试验中获得的积极临床数据以及其他临床数据表明,微生物组药物可能成为改变患者护理的下一个主要治疗类别。”

Finch Therapeutics首席财务官Greg Perry说:“这笔额外的资金使我们为下一步的发展做好了准备。” “除了让我们的主要候选药物CP101用于艰难梭菌复发之外,我们还希望从慢性乙型肝炎试验开始,快速评估CP101与微生物组破坏有关的许多其他情况。”

Finch将利用筹集的资金将CP101推进到艰难梭菌感染(CDI)的临床开发和监管提交的最终阶段,并推进其平台和开发流程,包括启动评估FIN-211的1b期研究自闭症谱系障碍(ASD)和CP101用于慢性乙型肝炎(HBV)。

“通过利用从临床数据中获得的见解开始发现过程,芬奇正在开拓一种新的,非常有前途的药物发现方法,” OMX Ventures董事总经理尼克·哈夫特说。复发的艰难梭菌仅是冰山一角,数十项概念验证的人类微生物群移植研究证明了这种方法在多种适应症中的潜力。通过其平台,Finch处于独特的位置,可以将许多令人兴奋的见解转化为有希望的新型微生物组疗法。”

这项融资基于Finch及其领先候选药物CP101的最新进展,CP101是一种研究型口服微生物组药物,旨在提供健康的肠道微生物组的全部多样性,满足其在大型安慰剂对照中预防CDI复发的主要功效终点今年年初进行审判。芬奇最近还宣布启动一项评估CP101治疗慢性HBV的计划,加强了临床前和临床研究,表明完整的微生物组的交付可能通过刺激先天免疫应答来驱动病毒清除。1-4芬奇专有管道还包括FIN-211,这是一种研究性口服微生物组药物,最初的目标是治疗患有严重胃肠道(GI)症状的ASD儿童。 FIN-211旨在重新建立正常的微生物组组成和功能,并通过临床前和临床研究表明胃肠道和行为症状可能与破坏的微生物组有关。5-8Finch与武田制药合作,还与开发由合理选择的菌株组成的研究性口服微生物组药物,旨在针对炎症性肠病发病机理的特定机制。芬奇与武田公司的第一个计划专注于开发用于溃疡性结肠炎的FIN-524。在用FIN-524实现关键的临床前里程碑之后,芬奇和武田公司扩大了合作伙伴关系,包括开发克罗恩病的FIN-525。

关于芬奇疗法
Finch Therapeutics正在开发新型微生物组药物,以满足严重未满足医疗需求的患者。 Finch的Human-FirstDiscovery®平台可从临床数据进行反向翻译,从而根据疾病改变机制设计微生物组的组成。 Finch的平台独特地支持完整的微生物组社区和合理选择的联合体的开发,以恢复微生物组的功能并解决由菌群失调或破坏引起的疾病。芬奇(Finch)的主要计划CP101,是一种研究性微生物组药物,具有美国食品和药物管理局(FDA)的快速通道和突破性疗法称号,用于预防艰难梭菌的反复感染。该公司还开发了用于治疗自闭症谱系障碍儿童的FIN-211和用于治疗慢性乙型肝炎的CP101。该公司与武田制药公司建立了战略合作伙伴关系,致力于开发用于炎症性肠病的微生物组药物。

    任等人。长期抗病毒治疗后,粪便菌群移植可诱导HBeAg阳性的患者清除乙肝病毒电子抗原(HBeAg)。肝病2017。
    谢等。长期抗病毒治疗后,粪便菌群移植导致HBEAG阴性慢性乙型肝炎患者的HBSAG下降。肠2018。
    Chauhan等。乙型肝炎e抗原阳性的慢性乙型肝炎患者的粪便菌群移植:一项初步研究。 Dig Dis Sci 2020。
    周等。与年龄相关的乙型肝炎病毒感染的免疫清除需要建立肠道菌群。 PNAS 2015。
    Kang等。微生物群转移疗法可改变肠道生态系统并改善胃肠道和自闭症症状:一项开放标签研究。微生物组2017。
    Kang等。微生物群转移疗法对自闭症症状和肠道菌群的长期益处。科学报告2019。
    宁等。粪便菌群移植治疗2010年肠病患者的疗效分析。中国肠胃外科杂志2019。
    Sgritta等。在自闭症谱系障碍小鼠模型中,微生物介导的社会行为变化的机制。神经元2018。



联络人

媒体联系人:
凯瑟琳·莫里斯(Kathryn Morris)
[email protected]
914-204-6412

投资者联系方式:
格雷格·佩里(Greg Perry)
[email protected]

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3
发表于 2020-9-18 09:18 |只看该作者
以后吃翔可以治好乙肝了。

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4
发表于 2020-9-18 11:16 |只看该作者
这个药前途在哪里?提供一种不确定的选择?俗称智商税?
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