Randomized, Placebo-controlled, Open-label, Phase 2b Clinical Trial to Evaluate the Antitumor Activity of Combination Therapy of SMT-NK and Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer

开始日期2022-06-09

申办/合作机构

SMT Bio Co., Ltd.

NCT03937895 / Completed临床1/2期

Phase 1/2a Clinical Trial for the Evaluation of Safety and Efficacy of Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab for Patients With Gemcitabine-refractory Biliary Tract Cancer

The term of biliary tract cancer (BTC) or cholangiocarcinoma refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder. According to the data from National Cancer Information Center in 2016, annual incidence of the cancer in Korea is 6,685 (13.1 per 100,000 population) which corresponds to about 2.9% of all cancers.
BTC is one of the most prognostic cancer with less than 30% of 5-year survival rate and the case with long-term survival can be possibly done with early detection of the cancer. However, most of BTC is found in advanced stages due to the difficulty of early detection, resulting in that the 5-year survival rate of the advanced BTC becomes less than 3%. More than 50% of the patients depends on Gemcitabine based chemotherapy but response rate of the chemotherapy remains around 30%. Thus, improving the survival rate with the standard chemotherapy is very limited and furthermore selection of second-line therapy is not easy. For this reason, development of an alternative therapeutic agent is urgently required.
NK (natural killer) cells are important cytotoxic innate immune cells that are involved in the elimination of cancer cells. Two main NK cell subsets have been defined on the basis of CD56 and CD16 expression: CD56^brightCD16- NK subset produces abundant cytokines including interferon-γ (IFN-γ) and tumor necrosis factor-α, whereas CD56^dimCD16+ NK subpopulation has high cytolytic activity and releases the granules containing perforin and granzymes.
Various clinical studies have been conducted to treat cancers using NK cells worldwide including Korea and therapeutic clinical results are shown for various cancers. The clinical application of NK cells is carried out by culturing and activating the NK cells isolated from blood of either patient (autologous) or blood donor (allogeneic). Recently, NK cell therapy for cholangiocarcinoma has been successfully done (NCT03358849) with allogeneic NK cell, showing safety and potential efficacy.
Like T cells, a recent study with digestive cancer has shown that NK cells also express PD-1, especially with more number of PD-1 in cancer patients than in healthy individuals, suggesting that blocking PD-1 can be used as a potential strategy to increase the anticancer activity of NK cells. Therefore, combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells.

开始日期2019-12-03

申办/合作机构

SMT Bio Co., Ltd.

NCT03358849 / Completed临床1期IIT

Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer

Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that develop in the gallbladder. According to the data from National Cancer Information Center in 2013, the incidence of cancer in Korea is 5,283, which corresponds to about 2.3% of all cancers and the 5-year survival rate is 30% And most of the long-term survival is due to early detection by screening, and advanced carcinoma is a refractory carcinoma with a 5-year survival rate of less than 5%. In addition to the standard anticancer drugs, alternative anticancer drugs and targeted therapies have been developed to provide a variety of treatment modalities. However, the development of cell therapy drugs for cancer, such as cancers, has not been developed in Korea. .
Natural killer cells (NK cells) are innate lymphocyte cells with cytotoxic activity. Unlike T cells and B cells, which have antigen-specific receptors, NK cells express various innate immunoreceptors on the cell surface, thereby enabling selective recognition of cancer cells And recognizes cancer cells, it is a cytotoxic cell that can immediately remove cancer cells without any other activation process. In addition, natural killer cells also interact with dendritic cells or T cells directly or indirectly to regulate the immune response, thereby inhibiting the development and metastasis of cancer cells and effectively removing cancer stem cells important for cancer recurrence It has many advantages in the development of anti-cancer immunotherapy.

开始日期2017-10-17

申办/合作机构

Yonsei University

100 项与 Natural killer cell therapy (SMT bio) 相关的临床结果

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100 项与 Natural killer cell therapy (SMT bio) 相关的转化医学

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100 项与 Natural killer cell therapy (SMT bio) 相关的专利（医药）

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项与 Natural killer cell therapy (SMT bio) 相关的文献（医药）

2018-01-01·In vivo (Athens, Greece)4区 · 医学

In Vivo Study of Natural Killer (NK) Cell Cytotoxicity Against Cholangiocarcinoma in a Nude Mouse Model

4区 · 医学

Article

作者: Yoo, DA Kyung ; Jeong, Seong Hoon ; Park, Seung Woo ; Jung, In Hye ; Baek, Sun Young ; Kim, DO Hee ; Chung, Yong-Yoon ; Jung, Dawoon E

BACKGROUND/AIM:

Natural killer (NK) cells are one of the lymphocytes clinically used for various cancer types. Cytotoxicity of NK cells to cholangiocarcinoma (CC), however, has not yet been studied. Nor NK cell therapy against CC has been clinically applied. In this study, relevance of NK cell therapy for anti-tumor efficacy against CC was pre-clinically investigated.

MATERIALS AND METHODS:

Human HuCCT-1 cells, an intrahepatic CC cell line, were xenografted into nude mice. The HuCCT-1 tumor-bearing nude mice then received multiple infusions of ex vivo-expanded human NK cells (SMT01) and in vivo cytotoxic activity of the NK cells against the CC cells was evaluated.

RESULTS:

SMT01 infusion resulted in significant inhibition of the CC tumor growth. Body weight of the mice administrated with chemotherapy was found to be maintained at the lowest level among all treatment groups while all the SMT01 infusion groups well maintained their body weight.

CONCLUSION:

The present in vivo study demonstrates that NK cells contain cytolytic activity against cholangiocarcinoma and show beneficial effect of NK cell therapy in relevance to quality of life. Further investigation of the NK cell-based immunotherapy can be useful to determine cancer therapeutics for the specific tumor.

2009-06-15·Huan jing ke xue= Huanjing kexue

[Investigation of sulfonamides and tetracyclines antibiotics in soils from various vegetable fields].

Article

作者: Wang, Ji-Yang ; Li, Ming-Yang ; Tai, Yi-Ping ; Liang, Wei-Ming ; Mo, Ce-Hui ; Bao, Yan-Ping ; Zhao, Na ; Li, Yan-Wen

The occurrence and distribution of 9 selected antibiotics, that involved with oxytetracycline (OTC), tetracycline (TC), chlortetracycline (CTC), sulfamethazine (SM2), sulfadiazine (SDZ), sulfamerazine (SMR), sulfameter, (SMT), sulfamethoxazole (SMZ) and sulfadimethoxine (SDM), were screened at 14 typical vegetable fields located in Shenzhen, Guangzhou, Huizhou, Dongguan regions,with high-performance liquid chromatography (HPLC). Data showed that almost all soil samples were unavoidably contaminated with antibiotics. The sum concentration of 3 tetracyclines (TCs) and 6 sulfonamides (SAs) in soils ranged from undetected to 242.6 microg/kg and 33.3 to 321.4 microg/kg respectively, while the medium concentrations were 84.8 microg/kg of tetracyclines and 121 microg/kg of sulfonamides. The individual detectable probability of the two groups of antibiotics ranged from 19.35% to 96.77% (TCs) and from 25.81% to 93.50% (SAs). TC, SMZ, SMT and SM2 were more abundant in soil among the selected antibiotics. The study also suggested that the total amount of both TCs and SAs in different vegetable fields ranked as hoggery vegetable field > non-pollution vegetable field > routine vegetable field > greenfood vegetable field, and there should exist some relationship between vegetable planting and antibiotics amount in soil which was related to different fertilization, irrigation and vegetable species. The concentrations of the selected antibiotics are comparable to those reported from the other countries in the world, but the detectable probability of the antibiotics in our study site is higher than that from the reference data. More attention should be paid to antibiotics pollution of soil in vegetable fields.

2006-09-28·Surgery today4区 · 医学

Reinforcement Therapy Using Nitric Oxide Synthase Inhibitors Against Endotoxin Shock in Dogs

4区 · 医学

Article

作者: Yoshiaki Imamura ; Masaru Fukuda ; Hiroyasu Suga ; Takao Nakagawa ; Yukihiro Soga ; Norio Miyoshi ; Yoshizumi Deguchi ; Tadashi Suzuki

PURPOSE:

Nitric oxide synthase (NOS) inhibitors were confirmed to correct the hypotension associated with septic shock, but the overall prognosis is often pessimistic. The histological findings failed to show any improvement. In fact, some patients even exhibited signs of exacerbation. The purpose of this study was to investigate the therapeutic effects of NOS inhibitors and catecholamines in dogs suffering from endotoxin shock. The histological changes produced by these agents were also evaluated.

METHODS:

Mongrel dogs were used under midazolam anesthesia. A PiCCO continuous cardiac output monitoring catheter was placed in the femoral artery, and a central venous monitoring catheter was placed in the external carotid artery.

RESULTS:

Endotoxin (0.5 mg/kg, i.v.) was administered to cause shock. After this shock state was observed, the NOS inhibitors and catecholamines raised the blood pressure, and norepinephrine (NA, 2 microg/kg/h) was found to be more potent than S-methylisothiourea (SMT, 20 microg/kg/h). The combined effects of SMT-NA or SMT-DOB were greater than those of NA or dobutamine (DOB) alone. The histological changes induced by endotoxin shock were not ameliorated by the administration of NOS inhibitors but instead appeared to be exacerbated to some degree.

CONCLUSION:

NOS inhibitors combined with cathecholamines were thus suggested to be able to reduce the cathecolamine dosage in patients suffering from septic shock; They are thus considered to be hemodynamically effective agents.

项与 Natural killer cell therapy (SMT bio) 相关的新闻（医药）

2024-09-09

·PRNewswire

Somite Therapeutics and OmniaBio Inc. Announce Collaboration to Advance Somite's Cell Therapy Flagship Program

CDMO collaboration propels cell replacement therapy targeting Duchenne muscular dystrophy forward, with consequences for the role of AI in cell therapy BOSTON and HAMILTON, Ontario, Sept. 9, 2024 /PRNewswire/ -- Somite Therapeutics, a tech-bio company harnessing big data and AI to pioneer novel cell replacement therapies, and OmniaBio Inc., a technology-driven cell and gene therapy CDMO founded by CCRM, today announced a cell therapy development and manufacturing collaboration for producing SMT-M01, Somite's flagship program for Duchenne muscular dystrophy (DMD). "I am excited about the long-term potential of this collaboration, which extends beyond this initial program," said Prof. Peter Zandstra, a Scientific Advisory Board member of Somite and Chief Scientific Officer of CCRM. "Somite's innovative use of AI to drive the discovery and optimization of cell therapy manufacturing presents our field with exciting opportunities to enhance the effectiveness and cost-efficiency of cell therapy products. This collaboration exemplifies how combining cutting-edge technology with deep scientific expertise can accelerate the development of transformative therapies." DMD is a rare, severe genetic disorder characterized by progressive muscle degeneration and weakness and has no known cure. The new collaboration leverages OmniaBio's extensive induced pluripotent stem cell (iPSC) experience to support Somite's development of a cell replacement therapy that aims to restore muscle function, slow disease progression, and improve quality of life for individuals living with DMD. "Working with OmniaBio allows us to leverage their unparalleled experience in iPSC technology and ensures that we can advance our DMD program efficiently and effectively," said Dr. Kristy Brown, SVP of Translational Development at Somite Therapeutics. "OmniaBio's collaborative approach and proven track record in process development and regulatory compliance provides us with confidence that we have found the ideal partner to bring our innovative therapies to patients in need." Through the collaboration, OmniaBio will conduct process optimization, master cell banking, differentiation of the pluripotent stem cells to the myogenic satellite cells, identification of harvest conditions and fill finish of the drug product. "We anticipate SMT-01 will enter phase 1/2 in 18-24 months, and this collaboration is a great step forward," said Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. "As the cells are produced, the data we'll be generating will allow us to fuel our AlphaStem foundation models, driving further advancements in our therapeutic approach. We are extremely excited about the future and the potential this collaboration holds for transforming both patient outcomes and stem cell biology at large." "Somite's flagship DMD program and AI-driven capabilities have the potential to significantly improve the lives of patients worldwide," said Mitchel Sivilotti, President and CEO of OmniaBio Inc. "We are thrilled to provide our deep iPSC platform expertise, combined with our new initiatives in AI, to deliver meaningful manufacturing process insights and analytical advancements, along with GMP manufacturing expertise to accelerate clinical translation for this vital program." About Somite Somite.ai is a venture-backed company aiming to become the OpenAI of stem cell biology, developing AI foundation models to produce human tissue for cell therapies at scale for diseases such as diabetes, obesity, and muscular dystrophies. Somite's AI platform, AlphaStem, fuels a virtuous cycle: It enables new cell therapies, generating massive data that further improve the platform, empowering even faster therapy creation with broader applications. The company's pipeline includes the promising SMT-M01 program for Duchenne muscular dystrophy (DMD) and the SMT-B01 program for metabolic disorders. Incorporated in Oct. 2023, Somite.ai has raised over $10m to date. Somite Management Team: Micha Breakstone, PhD: CEO and Co-founder - Repeat AI entrepreneur (Chorus.ai acq. for $575m) Jonathan Rosenfeld, PhD: CTO and Co-founder - Head of the Fundamental AI group at MIT FutureTech Carl Morris, PhD: Chief Scientific Officer Kristy Brown, PhD: SVP Translational Development Scientific Co-founders: Olivier Pourquie, PhD: Professor of Genetics and Pathology, Harvard Medical School and Brigham and Women's Hospital Allon Klein, PhD: Professor of Systems Biology at Harvard Medical School Cliff Tabin, PhD: Chair of the Department of Genetics at Harvard Medical School Jay Shendure, MD, PhD: HHMI Investigator and Professor of Genome Sciences at University of Washington About OmniaBio OmniaBio Inc. is a technology-focused, global cell and gene therapy CDMO with a vision to manufacture a disease-free world. As a subsidiary of CCRM, OmniaBio harnesses over a decade of expertise in regenerative medicine and advanced therapies. Offering comprehensive and tailored CDMO services, cutting-edge development and reliable Good Manufacturing Practices capabilities, OmniaBio specializes in immune cell-based therapies, induced pluripotent stem cell therapies and lentiviral vectors, driving advancements in the field and bringing maturity to cell and gene therapy. With existing clinical manufacturing capabilities and a commercial facility opening this fall, OmniaBio is poised to meet the surging global manufacturing demand, enabling access to transformative treatments for patients around the world. Please visit us at to learn more. For further information, please contact: Media Relations Somite Therapeutics [email protected] Stacey Johnson Vice President, Communications and Marketing CCRM and OmniaBio Inc. 647-309-1830 [email protected] SOURCE Somite Therapeutics

细胞疗法基因疗法

2022-09-01

·Science Daily

Improving foam stability in disinfectants with high ethanol concentrations

As the world adapts to the post-COVID era, disinfectants have become an irreplaceable part of life. Foam disinfectants are excellent but suffer from foam destabilization when mixed with high ethanol concentrations. To address this issue, researchers from Japan have added an anionic surfactant, a long-chain alcohol, and an inorganic electrolyte to aqueous solutions with high ethanol concentrations, demonstrating enhanced foam stability. Their strategy could enable the formulation of stable, foam-type hand sanitizers. Since the outbreak of COVID-19, the importance wearing masks and disinfection of items has become paramount. As a result, there is now a greater need for effective, potent, and simple-to-apply disinfectants. Foam-type disinfectants are a leading candidate in this regard since they do not drip, keep the disinfected area visible, and are less likely to reach the user's eyes. However, foam-type disinfectants are not without issues. While the foam is usually stabilized with the adsorption of a surfactant at the air/liquid interface, adding high concentration of ethanol, an antiseptic, to foams in aqueous solutions causes defoaming resulting from destabilization of the foam. To improve the stability of foam disinfectants at high ethanol concentrations, a group of researchers from Tokyo University of Science (TUS), Japan, in collaboration with the Life Science Products Division, NOF Corporation, have now come up with a new proposal. This study, led by Associate Professor Kenichi Sakai of TUS, was made available online on August 04, 2022 and published in Chemistry Letters. In their study, the team added an anionic (negatively charged) surfactant, long-chain alcohols, and an inorganic electrolyte to an aqueous solution containing 60% ethanol by volume. They used sodium methyl stearoyl taurate (SMT) as the surfactant, CnOH (where n = 12, 14, 16) as the alcohols, and magnesium sulfate (MgSO4) as the electrolyte. The inorganic electrolyte provided two main advantages: firstly, it enabled effective screening of the electrostatic repulsion between the SMT headgroup adsorbed at the air-liquid interface. Secondly, it promoted interactions between Mg2+ ions and the headgroups. These, in turn, facilitated the additional adsorption of SMT and CnOH, increasing the surface viscosity and foam stability. "We have been working on this research project before the novel coronavirus infection became a social problem. We believe that the social impact of this research will only increase as the social need for disinfectants and health safety go up," says Dr. Sakai, explaining his motivation behind the study. The team observed that, in the absence of the MgSO4, foaming occurred upon shaking for CnOH (n = 12, 14, 16) with the foam stability increasing with increasing n. Additionally, the combination of SMT and CnOH resulted in a decrease in surface tension and an increase in surface viscosity, which increased foam stability. When MgSO4 was added, foaming happened upon vigorous shaking. The foam stability increased with increase in the mole ratio of MgSO4, which decreased the surface tension while increasing the surface viscosity. Finally, the team used a non-pressurized commercial pump to test the foam formation of the solution. They found that the SMT and C14OH mixture produced adequate foaming both with and without MgSO4. Further, defoaming occurred after 30 seconds for both cases, an appropriate time scale for the dissipation of the foam after application. "The COVID-19 pandemic has seriously affected human lives and social activities on a global scale. As a result, the importance of proper sanitation has been recognized worldwide. We believe that the results of our research will contribute to the sustainable development goal (SDG3) of ensuring good health and well-being among people of all ages," says Dr. Sakai. Indeed, the team's samples could help formulate foam-type hand sanitizers you may be using soon.

2022-08-23

·生物谷

NK细胞疗法赛道，国内投资升温明显

NK细胞属于人体抵抗癌细胞、外敌入侵的第一道防线，不同于T细胞、B细胞，它无需预先致敏就能非特异性杀伤肿瘤细胞。 NK细胞属于人体抵抗癌细胞、外敌入侵的第一道防线，不同于T细胞、B细胞，它无需预先致敏就能非特异性杀伤肿瘤细胞。除了杀伤速度快且范围广泛，相比于炙手可热的CAR-T疗法，NK细胞疗法还拥有安全性好、成本低等诸多优点，因此研究也很火热。近两年来NK细胞疗法发展迅速。有较多公司在开发CAR-NK，另有一些是单纯的NK细胞。此外，也有贝斯昂科等公司开发了特色的super-NK细胞。CAR-NK的设计类似于CAR-T，将CAR装载在NK细胞上，相当于增加了一个导航装置，大大提高了其针对肿瘤抗原靶向性；Super-NK类主要是在NK细胞上下功夫，经过基因工程处理后的NK细胞在功能性上明显增强，对血液瘤和实体瘤具有显著的杀伤能力；iPSC-CAR-NK则是CAR-NK的升级版，iPSC细胞所具备的无限增殖能力，可提供大量细胞来源。目前，已有多种类型的NK细胞疗法进入临床开发，用于治疗多种实体瘤、血液瘤，给许多肿瘤患者带来了希望。随着CAR-T细胞疗法的商业化上市以及市场规模逐步放大。NK细胞疗法作为细胞疗法的一个分支，也凝聚了越来越高的热度，诸多公司和投资机构进入这一赛道。海外有多家布局NK细胞疗法的公司登陆纳斯达克，如Nkarta Therapeutic、Fate Therapeutics、Century Therapeutics、Caribou Biosciences、Cytovia Therapeutics。国内也有越来越多的NK细胞疗法异军突起，如优凯瑞、呈诺医学、重庆精准生物、阿思科力、科伦博泰、英百瑞、博生吉等。从投资数据的角度来看，NK细胞疗法领域热度不断攀升。医药魔方发布的“2021全球细胞疗法投融资年度报告”显示，NK细胞疗法赛道2021年全球融资总额超14亿美元，在T细胞疗法（超73亿美元）和干细胞疗法（超25亿美元）后位列第三。此外，该领域也受到12家制药巨头的青睐，涌现大额合作，如2021年1月28日，默沙东与Artiva Biotherapeutics超18亿美元的全球独家合作和许可协议；2021年6月17日，吉利德旗下的Kite Pharma与Shoreline Biosciences达成总额超23亿美元的合作。不过NK细胞疗法赛道近两年的投融资热度表现出了地域和时间上的明显差异和变化。 2021年的NK细胞疗法投融资（包括IPO）在国外的热度更高，有Caribou Biosciences、HCW Biologics、Celularity、ImmunityBio这4家公司IPO上市。另外，Acepodia、Century Therapeutics、GAIA BioMedicine、Wugen、Artiva Biotherapeutics、Senti Bio等几家公司完成了C轮/B轮融资。而国内的再凌生物（种子轮）、星奕昂（天使轮）、贝斯生物（天使轮）、启函生物（A++轮）等还处于早期融资阶段。从数字上看，2021年NK细胞疗法相关投融资事件中，国内公司占比为23%（5/22）。但是进入2022年之后，国内NK细胞疗法的投融资热度显著上升，投融资事件全球占比已经达到67%（10/15）。 NK细胞疗法国内外投融资事件数量国内NK细胞疗法赛道在2022年出现了很多“新身影”，如恩凯赛药（A轮）、景达生物（分别于1月、6月完成天使轮和Pre-A轮）、河络新图（天使轮）、昕传生物和济因生物（种子轮）等。 2022年NK细胞疗法领域国内最新投融资概况值得一提的是，用ADC思路开发细胞免疫疗法的英百瑞在2022上半年NK细胞疗法领域融资金额以2.3亿元位列第一。融资所得将主要用于推动该公司独有的非基因修饰的CAR-raNK®和tiNK®细胞疗法的开发，推动公司领先的现货型CAR-raNK®细胞疗法候选药物IBR733和IBR854管线进入临床，加速公司多个tiNK®和NK Cell Engager细胞疗法候选药物的IND-enabling研究。特色技术平台CAR-raNK®核心构造是将靶向肿瘤抗原的特异性抗体通过连接子（linker）与同种异体的NK细胞进行化学/共价偶联。tiNK细胞疗法可增强特定NK细胞在体内的存活时间和杀伤活性。英百瑞创始人兼 CEO苗振伟提到，在CAR-raNK®、tiNK®两大核心技术的加持下，目前英百瑞已经开发了 13 个产品，将陆续推至临床。今年内，至少会有 2 款产品进入 IND 阶段。对于顺利完成A轮融资，他还表示：“英百瑞将继续以患者为中心，以临床价值为导向，致力于成为全球CAR-NK细胞治疗领域的领导者。” 国外方面，2022年的NK细胞疗法融资大多为 “老玩家”的进一步动作，鲜见新玩家的进入。例如Inceptor Bio已于去年6月14日完成种子轮融资；Senti Bio于去年1月6日完成1.05亿美元B轮融资；Onk Therapeutics于2020年10月19日完成一轮800万美元融资。此外，Cytovia Therapeutics和Senti Bio宣布IPO。 2022年NK细胞疗法领域国外最新投融资概况其中，由MIT合成生物学大牛卢冠达等人于2016年创办的Senti Bio无疑是值得关注的。该公司在利用合成生物学设计“基因回路”以改善细胞和基因治疗产品方面处于领先地位。Senti Bio旨在使用基因回路的逻辑门改造CAR-NK细胞，使其能够分辨出肿瘤相关的抗原和健康细胞产生的抗原，最终达到保护健康细胞、精准有效杀灭癌细胞的目的。 2021年1月6日，Senti Bio 宣布已完成拜耳飞跃计划领投的1.05亿美元B轮融资。此前，Senti Bio于2018年2月完成了5300万美元A轮融资。A、B两轮融资累计超1.5亿美元。今年6月9日，Senti Bio宣布完成与Dynamics Special Purpose Corp的业务合并，并于同日登陆了纳斯达克，预计可获得共计1.403 亿美元的资金。与此同时，两条主要管线SENTI-202（利用 “或” 门和 “非” 门改造靶向治疗急性髓性白血病）和 SENTI-301（使用基因回路增强细胞功效治疗肝细胞癌）预计将于2023年进行IND申请。除这两条主要管线外，Senti Bio还有在研管线SENTI-401（利用“非”门改造的CAR-NK疗法针对结直肠癌）。除了自身的在研管线，Senti Bio还与多家头部企业展开了合作，将其基因电路技术应用于肿瘤学之外。包括与罗氏旗下Spark Therapeutics达成超6.45 亿美元的合作协议，拜耳的全资子公司BlueRock Therapeutics也是其研发合作伙伴。总的来说，2022年，国内NK细胞疗法赛道热度上升，超越国外。但项目进展度方面仍是国外保持领先。据医药魔方NextPharma数据库，目前尚未有NK细胞疗法上市，进展最快的为SMT bio公司治疗胆道癌的NK细胞疗法产品SMT-NK，处于II/III期临床阶段。CAR-NK细胞疗法进展最快的为NantKwest( ImmunityBio )治疗胰腺癌、三阴性乳腺癌等实体瘤的PDL1.t-haNK，处于II期临床阶段。这一赛道正敞开怀抱欢迎玩家加入。通用化、量产化、实体瘤是细胞治疗领域的三大突破目标，而NK细胞疗法在这些方面都有较大的潜力，包括：1）不受T-reg细胞抑制，不会在实体瘤微环境中受到负调节，在实体瘤应用中具有优势；2）不会引起移植物抗宿主病（GvHD），因不分泌炎症因子（如IL1、 IL6）一般不诱发细胞因子风暴（CRS），安全性较高，适合作为现货型产品使用；3）在体内存活周期短，不易产生长期的毒副作用；4）具备更多的肿瘤杀伤途径，如执行细胞脱粒、激活凋亡途径和介导ADCC的功能。杀伤肿瘤细胞不受MHC识别的限制。这些优点使得NK细胞疗法相比CAR-T、TCR-T具有更广阔的应用前景，也具有更好的工业化生产潜力。与此同时，NK细胞疗法的开发也存在一些挑战，包括：1）体外扩增困难。不论是什么来源的NK细胞，外周血、脐带血或者是干细胞来源，扩增都是目前一个比较大的瓶颈；2）NK细胞更像百米短跑选手，杀伤速度快且范围广泛，但持续性不如T细胞；3）NK细胞的转染效率有待提高。目前NK细胞治疗产品通常都要利用基因工程改造，这就涉及到NK细胞的转染。不论是用病毒转染、电转或者其他方式的转染，对NK细胞来说都是一个难题。因为NK细胞是一种先天性免疫细胞，天然对外来的病毒或者质粒会有抵抗作用，甚至转染进病毒的NK细胞也很容易被周围其他NK细胞识别为变异细胞而清除……这些问题引发的对产能和治疗次数的要求可能会降低NK细胞疗法的成本优势和使用依从性。优点与缺点并存，希望与不安交织。尽管如此，困难无法阻止探索者的脚步。有专家表示NK细胞疗法领域发展迅速，有点类似于6、7年前的CAR-T。相信随着加入该赛道的玩家不断增多，NK细胞疗法未来可期。由生物谷作为主办方之一的“2022（第十三届）细胞治疗大会”即将拉开序幕，与此同时，2022细胞治疗项目路演专场也同时开启！（会议时间：定向通知）为推进细胞治疗的产业化进程，更好地为初创企业搭建细胞治疗技术及产品转化的平台，同时搭建投融资双方沟通的桥梁，2022细胞治疗项目路演专场将特别为创业企业提供项目展示的机会，充分利用行业活动的最佳场合，以期促成更多的行业合作。如果您的创业团队有优秀的CAR-T/TCR-T/CAR-NK等细胞治疗在研项目、干细胞/免疫细胞治疗突破性疗法、肿瘤治疗新靶点、基因编辑创新技术、细胞先进生产制造工艺等方面的项目，欢迎申报！（长按下方二维码填写项目）申报项目特别福利： 1.主办方审核通过后，我们将给项目团队15分钟演讲时间。 2.为鼓励创业团队参与，团队成员可以有3个免费参会名额。席位有限，请尽快锁定演讲机会！（截止时间：9月13日23:00）长按二维码填写专场听众特别福利：直接注册项目路演入场票，现在报名0元！（该票仅适用于“细胞治疗项目路演专场”，仅供专业投资机构、企业投资部门、政府机构等相关人士使用）合作伙伴火热招募中...... 大会开放主题演讲、产品展示、合作邀约等多种形式，供您展示公司产品、案例、以及品牌形象！

细胞疗法免疫疗法合作IPO基因疗法

100 项与 Natural killer cell therapy (SMT bio) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期胆管癌	临床3期	韩国	SMT Bio Co., Ltd.	2022-06-09
胆管癌	临床1期	韩国	Yonsei University College of Medicine	-

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05429697 (ASCO2023) 人工标引	临床1/2期	胆道癌	40	Pembrolizumab+SMT NK	艱鏇構繭構衊鏇顧遞蓋(鹽築窪廠鏇淵製範願範) = 積醖齋鏇膚鏇襯遞積製艱製蓋糧糧顧顧壓廠襯 (蓋積鹹遞構鹹顧鏇繭夢 ) 更多	积极	2023-05-26
NCT05429697 (ASCO2023) 人工标引	临床1/2期	胆道癌	40	Pembrolizumab	艱鏇構繭構衊鏇顧遞蓋(鹽築窪廠鏇淵製範願範) = 鏇築壓膚願積製繭觸鹽艱製蓋糧糧顧顧壓廠襯 (蓋積鹹遞構鹹顧鏇繭夢 ) 更多	积极	2023-05-26
NCT03937895 (AACR2021) 人工标引	临床1/2期	胆管癌	40	SMT-NK+Pembrolizumab	網築鹹艱膚繭鹹廠膚餘(夢選構淵廠艱餘簾醖淵) = 鏇壓選淵範蓋觸遞夢蓋夢積蓋艱選鏇遞鬱醖蓋 (憲鏇淵選繭廠顧繭齋憲 ) 更多	积极	2021-07-01