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 Vivo4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: Jung, In Hye ; Park, Seung Woo ; Yoo, DA Kyung ; Jung, Dawoon E ; Kim, DO Hee ; Chung, Yong-Yoon ; Jeong, Seong Hoon ; Baek, Sun Young

BACKGROUND/AIMNatural 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 METHODSHuman 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.RESULTSSMT01 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.CONCLUSIONThe 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: Tai, Yi-Ping ; Liang, Wei-Ming ; Mo, Ce-Hui ; Bao, Yan-Ping ; Li, Yan-Wen ; Wang, Ji-Yang ; Li, Ming-Yang ; Zhao, Na

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

PURPOSENitric 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.METHODSMongrel 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.RESULTSEndotoxin (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.CONCLUSIONNOS 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）

2024-11-11

·PRNewswire

NK Cell Therapy Clinical Trial Pipeline Appears Robust With 140+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology. LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's ' NK Cell Therapy Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain. Key Takeaways from the NK Cell Therapy Pipeline Report DelveInsight's NK cell therapy pipeline report depicts a robust space with 140+ active players working to develop 160+ pipeline NK cell therapies. Key NK cell therapy companies such as Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape. Promising NK cell therapies in the pipeline such as Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials. In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders. In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase II clinical development. In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. In April 2024, Sanofi moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers. In April 2024, the FDA granted orphan drug designation to the investigational therapy IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML). In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Request a sample and discover the recent advances in the NK cell therapy segment @ NK Cell Therapy Pipeline Report The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape. NK Cell Therapy Overview Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells. The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients. Find out more about NK cell therapy @ Novel NK Cell Therapies A snapshot of the Pipeline NK Cell Therapies mentioned in the report: Learn more about the emerging NK cell therapies @ NK Cell Therapy Clinical Trials NK Cell Therapy Therapeutics Assessment The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration. Scope of the NK Cell Therapy Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others. Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others. Dive deep into rich insights for new NK cell therapies, visit @ NK Cell Therapy Drugs Table of Contents For further information on the NK cell therapy pipeline therapeutics, reach out @ NK Cell Therapy Treatment Drugs Related Reports NK Cell Therapy Market NK Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NK cell therapy companies including Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

细胞疗法孤儿药快速通道免疫疗法临床2期

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

2022-08-23

·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

10 条进展最快的记录,

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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	药物发现	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 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	胆道癌	40	Pembrolizumab+SMT NK	(築獵糧獵遞獵齋鏇衊獵) = 廠繭餘遞範鏇鑰簾齋鹹衊廠製膚窪齋餘願壓鹽 (簾顧網襯襯餘製願醖壓 ) 更多	积极	2023-05-26
NCT05429697 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	胆道癌	40	Pembrolizumab	(築獵糧獵遞獵齋鏇衊獵) = 窪觸鏇餘糧糧製廠糧衊衊廠製膚窪齋餘願壓鹽 (簾顧網襯襯餘製願醖壓 ) 更多	积极	2023-05-26
NCT03937895 (AACR 12021 \| AACR 22021) 人工标引	临床1/2期	胆管癌	40	SMT-NK+Pembrolizumab	(壓簾醖窪醖築憲簾鑰廠) = 衊憲淵艱鹹淵壓願鏇鑰鑰鹹願窪鹽衊遞淵艱夢 (壓鹽齋糧鑰窪願鹽遞艱 ) 更多	积极	2021-07-01