PRINCETON, N.J.--( BUSINESS WIRE )-- Kanvas Biosciences , a full-stack spatial biology company, today announced results from a clinical trial of fecal microbiota transplantation (FMT) and anti-PD-1 re-induction in microsatellite instability-high (MSI-H) refractory cancers. Presented at the third annual Society for Immunotherapy of Cancer (SITC) meeting, the trial data show that FMT enabled a response to reintroduced anti-PD-1 in patients with anti-PD-1 refractory, MSI-H cancers, and suggest that the gut microbiome affects anti-tumoral immunity in a tumor-agnostic manner. “The strains in our lead drug candidate, KAN-001, were isolated from the same donor who provided FMT material for this clinical trial. All strains present in KAN-001 were delivered to trial participants via FMT, where most if not all successfully engrafted,” said Dr. Kyle Jacoby , Vice President of Clinical Research at Kanvas Bio. “This significantly de-risks the clinical development of KAN-001, which seeks to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs) like anti-PD-1. With this trial data, Kanvas Bio is in the unique position of having positive human immuno-oncology data on the safety, efficacy and engraftment of the strains that comprise our drug candidate before initiating our own clinical trial for KAN-001.” Participants in the trial included 10 patients with colorectal cancer, two with small bowel adenocarcinomas, one with pancreatic adenocarcinoma, one with endometrial adenocarcinoma and one with a pineal brain tumor. Each participant underwent FMT via colonoscopy, receiving an FMT from a metastatic MSI-H colorectal cancer patient who achieved a complete response (CR) on anti-PD-1 therapy. Result highlights include: Three out of 15 (20%) participants responded to treatment, including one colorectal cancer patient who achieved an ongoing CR >2 years. Engraftment was remarkably high, with significant levels of donor strains in the majority of participants. No incidents of ICI-induced colitis occurred. “The gut microbiome has previously been associated with response to anti-PD-1 therapy, but the mechanisms that impact its effect on anti-tumoral immunity have been unclear,” said Dr. Erez Baruch , presenting author and Medical Oncology Fellow at The University of Texas MD Anderson Cancer Center. “Our trial results demonstrate that FMT enables a response to reintroduced anti-PD-1 in patients with anti-PD-1 refractory, MSI-H cancers.” Baruch is presenting these data as abstract #1266 at SITC on November 9 at the George R. Brown Convention Center in Houston, TX. Kanvas Bio plans to request a pre-Investigational New Drug meeting with the FDA for KAN-001 in January 2025, with the goal of beginning a clinical trial for the drug as soon as possible. For more information on the company’s therapeutic pipeline, or to inquire about partnership opportunities, visit www.kanvasbio.com or speak with the team in-person at SITC’s annual meeting in Houston November 6 - 10. To access the full clinical trial results, see the poster here . About Kanvas Biosciences Kanvas Biosciences is a spatial biology company building the world’s first microbiome drug screening, discovery and manufacturing platform to accelerate the development of next generation live biotherapeutics. With an unparalleled ability to spatially map the microbiome and profile host gene expression, and manufacture complex consortia containing hundreds of members that can restore microbiome health, the company is uniquely positioned to develop novel therapeutics that can significantly improve the lives of all patients living with microbiome-associated diseases. Kanvas Biosciences' technology was initially developed at Cornell University and exclusively licensed. The company's notable investors include DCVC, Lions Capital LLC, FemHealth Ventures, Germin8, Ki Tua Fund, Pangaea Ventures, Triple Impact Capital and Uncommon Denominator. Kanvas Biosciences is headquartered in Princeton, NJ. For more information, visit www.kanvasbio.com or follow the company on LinkedIn .

临床研究免疫疗法微生物疗法临床结果

2024-07-08

·创鉴汇

8家创新药公司获融资！1.7亿美元助力眼科基因疗法新锐 | 一周融资

▎药明康德内容团队编辑据创鉴汇不完全统计，上周（7月1日至7月7日）全球大健康领域共披露融资事件19起，总额超37亿元。按照金额划分，亿元及以上融资6起。按照已披露的融资轮次划分，早期融资（B轮以前）8起，中后期融资（B轮及以后）8起。生物医药领域共8家公司获融资，涉及药物类型包括基因疗法、微生物组药物、核酸药物等。 #01 Beacon Therapeutics完成1.7亿美元B轮融资关键词：眼科疾病基因疗法最新融资：1.7亿美元B轮本轮投资机构：Advent Life Sciences、Forbion、Oxford Science Enterprises、Syncona Limited、TCG Crossover 7月4日，Beacon Therapeutics宣布已完成1.7亿美元B轮融资。该融资由Forbion领投，TCGX和Advent Life Sciences参与，现有投资者Syncona Limited、Oxford Science Enterprises、牛津大学也参与其中。这些资金将用以支持Beacon用于治疗X连锁视网膜色素变性（XLRP）的主打在研基因疗法AGTC-501的持续临床开发，并支持该公司的干性老年性黄斑变性（dAMD）项目的1/2期临床试验。Beacon同时专注于罕见病和大众疾病疗法的开发，包括dAMD以及目前尚无获批疗法的致盲罕见疾病XLRP。AGTC-501是该公司的主打项目，目前正在进行用于XLRP治疗的注册性临床试验。 #02 慕恩生物完成3亿元C+轮融资关键词：微生物组药物最新融资：3亿元C+轮本轮投资机构：国投聚力 7月1日消息，慕恩生物宣布已于近日完成了3亿元C+轮融资，由国投聚力独家投资。根据新闻稿，新一轮资金将主要用于推进该公司更多生物创新产品的规模化生产和商业化落地等。慕恩生物是一家专注于微生物发掘与生物制造的生物技术公司。在生物医药板块，慕恩生物目前已有3项临床在研阶段药物与多个临床前药物管线研发，涵盖肿瘤、肥胖、2型糖尿病、非酒精性脂肪性肝炎等多项治疗领域。其中，该公司自主研发的创新型活菌生物药MNC-168肠溶胶囊目前正在开展1期临床研究。 #03 安天圣施完成近亿元A轮融资关键词：小核酸药物最新融资：近亿元A轮本轮投资机构：和瑞创投、国投创业 7月1日，苏州安天圣施医药科技有限公司（简称“安天圣施”）宣布完成近亿元A轮融资。本轮融资将用于推动新技术研发、商业化生产实施、国际化经营战略布局等，并将加速推进针对杜氏肌营养不良（DMD）、脊髓小脑共济失调、亨廷顿舞蹈症等罕见病的药物研发和注册临床试验，推动多个后续创新管线的产品开发，促进国际合作。安天圣施是一家以RNA剪接和RNA编辑为靶标研发反义寡核苷酸（ASO）药物的公司，创始人华益民教授为ASO药物领域知名科学家。该公司目前有多个项目在推进中，其中针对脊髓小脑性共济失调3型、杜氏肌营养不良等疾病候选产品已取得良好的临床前数据。 #04 Kanvas Biosciences完成1250万美元融资关键词：微生物组药物最新融资：1250万美元A轮本轮投资机构：Data Collective Venture Capital、FemHealth Ventures、Germin8 Ventures、Ki Tua Fund、Lions Capital 、Pangaea Ventures 7月1日消息，Kanvas Biosciences宣布筹集到1250万美元的额外资金。这笔资金将用于进一步开发该公司的空间生物学平台，并推进其免疫肿瘤计划中的两个新疗法，KAN-001和KAN-003，其中，KAN-001将于2025年提交新药临床试验（IND）申请。根据公司介绍，Kanvas Biosciences的空间生物学平台具有独特的能力，可以映射宿主-微生物群落相互作用，并利用产生的数据设计活性生物治疗产品(LBPs)，这些产品可以用于创制新型的微生物群落疗法，优化微生物群落——这是人类健康的关键因素。公司的主导药物候选KAN-001是一种LBP，显示出对提高对免疫检查点抑制剂（ICIs）产生抵抗的癌症患者的预后有重大潜力。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

临床1期基因疗法寡核苷酸

2024-07-01

·PRNewswire

Kanvas Biosciences Secures Additional $12.5M to Advance Its Novel, Microbiome-Based Immuno-oncology Drug Candidates to IND Filing

With $29.5 million in total funding, the company has developed the world's leading spatial biology platform, designed for breakthroughs in drug development, clinical diagnostics, agriculture, and food safety. This proprietary mapping technology will first be used to leverage the microbiome - a critical factor in human health – in order to manufacture a therapeutic with significant promise for improving outcomes in ICI-refractory cancers. PRINCETON, N.J., July 1, 2024 /PRNewswire/ -- Kanvas Biosciences, a full-stack spatial biology company, today announced it has raised $12.5 million in additional funding co-led by existing investors DCVC and Lions Capital LLC, and participation from FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures as well as existing investors. Paul Theunissen, Managing Partner at Lions Capital Partners LLC, will join the company's Board, and Ashlie L Burkart, MD, Chief Scientific Officer of Germin8 Ventures, will join as a board observer. The fresh capital closely follows a June 2023 round and brings Kanvas's total funding to $29.5 million. The funding will be used to further develop the company's spatial biology platform and advance two novel therapeutics in its Immuno-oncology Program, KAN-001 and KAN-003 — KAN-001 to an Investigational New Drug (IND) filing in 2025. The Kanvas platform is unique in its ability to spatially map gene expression and cellular function across all kingdoms of life. Its unprecedented capability to illuminate host-microbiome interactions marks a significant advancement in understanding diseases related to the microbiomes, finally unlocking the promise of microbiome-based therapies. The platform provides not only a path to breakthroughs in drug development, but also clinical diagnostics, agriculture and food safety. Kanvas Bioscience's spatial biology platform provides the unique ability to map host-microbiome interactions and leverage the resulting data to design live biotherapeutic products (LBPs), which can be used to create novel microbiome-based therapies that optimize the microbiome – a critical factor in human health. KAN-001, the company's lead drug candidate, is an LBP demonstrating significant potential to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs). Designed with the goal of increasing the percentage of patients who respond to ICIs across all ICI-approved cancer types, KAN-003 will be a defined consortium for cancer patients, administered just before starting ICI treatment. Kanvas is collaborating with The University of Texas MD Anderson Cancer Center and its Platform for Innovative Microbiome and Translational Research (PRIME-TR) to conduct additional preclinical studies for KAN-001 to optimize the drug's formulation and prepare it for an IND filing in 2025, preparatory to recruiting the first patients for a clinical trial the same year. "We have a remarkable opportunity to help patients by offering them an effective, novel therapeutic approach to some of the most common and debilitating conditions, starting with improving the efficacy of immunotherapy in the treatment of solid organ cancer. I'm so proud of the extraordinary progress the Kanvas team has already achieved," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "Because of this progress and with additional capital, Kanvas is positioned to accelerate its growth and build on its early success in illuminating host-microbiome interactions by launching a clinical pipeline of precision microbiome therapeutics." With a market expected to grow at a 21% CAGR to over $3 billion by 2031, LBPs are living microbes and can improve treatment outcomes for microbiome-addressable conditions, including solid organ cancer, inflammatory bowel disease and metabolic disorders. By acting in a synergistic and complementary manner to existing therapies, LBPs provide a safe method for targeting underlying disease processes, but through different pathways and with greater efficacy. Historical approaches to LBP development have generally focused on single strains of bacteria – which don't have an appropriate ecosystem to add therapeutic value – or fecal microbiota transplants (FMTs), which are complex and consist of many bacterial strains, but are difficult to scale commercially, highly variable and cannot be optimized. Kanvas has demonstrated the ability to develop and manufacture complex microbial consortia of 148 bacterial strains, providing the benefits of a complex community with multiple mechanisms of action, which make LBPs more effective. "Not only does Kanvas's spatial biology platform offer much-needed discovery capabilities, it also now enables the manufacturing of complex LBPs as a therapeutic modality. KAN-001 and KAN-003 have the potential to be breakthrough, complementary therapeutics for ICI-refractory and ICI-naive cancers," said Jason Pontin, General Partner at DCVC and chair of Kanvas's board. "By providing the missing link between microbiome drug design rationale and therapeutic outcomes, Kanvas has the unique and exciting ability to provide a better mechanistic understanding of microbiome-addressable conditions, and ultimately improve clinical success for the next generation of LBPs." "I'm thrilled to support Kanvas's mission as a board observer," remarked Dr. Burkart, Germin8's Chief Scientific Officer and a board-certified pathologist specializing in gastrointestinal pathology. "Their exceptional team and groundbreaking technology will revolutionize our understanding of host-microbiome interactions, driving transformative discoveries in human health and beyond. This tool isn't just relevant for human health; it holds promise for sectors like animal health and agriculture. Understanding microbes in these areas is vital for global health and sustainability." The past 12 months have been a period of momentous growth for Kanvas. This fall, the company opened a new research laboratory and drug manufacturing facility in South San Francisco. Kanvas also recently expanded its leadership team: Lee Swem, formerly Federation Bio's Chief Science Officer, joined Kanvas as Chief Development Officer, Steve Kujawa, who previously led business development at 10x Genomics, joined as Vice President of Business Development, and Kevin Cutler joined the company as Lead Scientist with expertise in AI. Swem is driving the execution of Kanvas's LBP portfolio, with a focus on KAN-001, and Kujawa is leading partnerships for the company's spatial biology platform and licensing of non-core LBP assets. Cutler is spearheading the curation of a state-of-the-art training database for machine learning segmentation of microbes, development of deep learning models for spectral identification of microbes, and integration of advanced AI into the company's analytical platform. For more information on Kanvas Biosciences or to inquire about pharmaceutical discovery partnership opportunities, visit . About Kanvas Biosciences Kanvas Biosciences is a spatial biology company building the world's first microbiome drug screening, discovery and manufacturing platform to accelerate the development of next generation live biotherapeutics. With an unparalleled ability to spatially map the microbiome and profile host gene expression, and manufacture complex consortia containing hundreds of members that can restore microbiome health, the company is uniquely positioned to develop novel therapeutics that can significantly improve the lives of all patients living with microbiome-associated diseases. Kanvas Biosciences' technology was initially developed at Cornell University and exclusively licensed. The company's notable investors include DCVC, Lions Capital LLC, FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures. Kanvas Biosciences is headquartered in Princeton, NJ. For more information, visit or follow the company on LinkedIn. SOURCE Kanvas Biosciences

高管变更免疫疗法微生物疗法

100 项与 KAN-001 相关的药物交易

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