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）

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

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.

2005-09-01·Bioorganic & Medicinal Chemistry3区 · 医学

Preparation of transition-state analogues of sterol 24-methyl transferase as potential anti-parasitics

3区 · 医学

Article

作者: Vanessa Yardley ; Ian H. Gilbert ; Carmen Jimenez Jimenez ; Simon L. Croft ; Dolores Gonzalez Pacanowska ; Silvia Orenes Lorente ; Luis M. Ruiz-Perez ; Julio A. Urbina ; Kate de Luca-Fradley ; Ludovic Gros

There is an urgent need for new drugs to treat leishmaniasis and Chagas disease. One important drug target in these organisms is sterol biosynthesis. In these organisms the main endogenous sterols are ergosta- and stigmata-like compounds in contrast to the situation in mammals, which have cholesterol as the sole sterol. In this paper we discuss the design, synthesis and evaluation of potential transition state analogues of the enzyme Delta24(25)-methyltransferase (24-SMT). This enzyme is essential for the biosynthesis of ergosterol, but not required for the biosynthesis of cholesterol. A series of compounds were successfully synthesised in which mimics of the S-adenosyl methionine co-factor were attached to the sterol nucleus. Compounds were evaluated against recombinant Leishmania major 24-SMT and the parasites L. donovani and Trypanosoma cruzi in vitro, causative organisms of leishmaniasis and Chagas disease, respectively. Some of the compounds showed inhibition of the recombinant Leishmania major 24-SMT and induced growth inhibition of the parasites. Some compounds also showed anti-parasitic activity against L. donovani and T. cruzi, but no inhibition of the enzyme. In addition, some of the compounds had anti-proliferative activity against the bloodstream forms of Trypanosoma brucei rhodesiense, which causes African trypanosomiasis.

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

2022-09-01

·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.

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

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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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