The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of this approach in preclinical models and in canine patients with a spontaneous malignant glioma. In one arm of this study, we will investigate the safety and immunologic activity of RNA-LP vaccines in pediatric patients with recurrent pHGG.
The investigators have also shown that intravenous administration of tumor mRNA loaded lipid particles (LPs) localizes primarily to lung, transfect antigen presenting cells (APCs) and lead to an activated T cell response for induction of anti-tumor immunity. In contrast to other formulations, RNA-LPs recruit multiple arms of the immune system (i.e. innate/adaptive), and remodel the systemic/intratumoral immune milieu, which remain potent barriers for vaccine, cellular, and checkpoint inhibiting immunotherapies. After only a single RNA-LP vaccine, the bulk of systemic and intratumoral dendritic cells (DCs) in mice display an activated phenotype; these activated DCs (harvested from tumors) expand antigen specific T cell immunity. In immunologically resistant pulmonary osteosacroma murine tumor models (i.e. K7M2), RNA-LPs induce robust anti-tumor efficacy in settings where immune checkpoint inhibitors (i.e. anti-PD-L1 therapy) do not confer therapeutic benefit. The investigators have already demonstrated safety of RNA-LPs in acute/chronic murine toxicity studies, and in client-owned canine trial.
In this study, we will investigate the manufacturing feasibility, safety and immunologic activity of RNA-LP vaccine in patients with recurrent pulmonary or unresectable osteosarcoma and recurrent pHGG.

Start Date12 Mar 2025

Sponsor / Collaborator

University of Florida

[+4]

NCT04299880

/ CompletedPhase 1

A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols

This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.

Start Date24 Feb 2020

Sponsor / Collaborator

Sumitomo Pharma America, Inc.

NCT03721744

/ RecruitingPhase 2/3

A Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

This is a Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

Start Date25 Oct 2018

Sponsor / Collaborator

1globe Health Institute LLC

100 Clinical Results associated with Napabucasin

100 Translational Medicine associated with Napabucasin

100 Patents (Medical) associated with Napabucasin

178

Literatures (Medical) associated with Napabucasin

01 Mar 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Recent progress of napabucasin as privileged scaffold in the discovery of anticancer agents

Review

Author: Ma, Guoyang ; Yang, Xiaojuan

Cancer is a major health issue worldwide, necessitating the development of novel treatments because treating this disease is challenging. Napabucasin, a furan-fused 1,4-naphthoquinone, exhibits significant anticancer activity through various molecular mechanisms and has become a privileged scaffold for developing antitumor therapeutics. In this review, we systematically evaluated recent progress in the use of napabucasin as a privileged scaffold for the discovery of antitumor drugs, focusing on structure-activity relationships (SARs), structural modification strategies, and the illustration of tumor inhibitory pathways from a mechanistic perspective. By conducting multidimensional assessments, we propose feasible directions for developing napabucasins with improved pharmacological properties for cancer treatment.

01 Jan 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of a novel napabucasin derivative B16 as a potent STAT3 inhibitor for the treatment of triple-negative breast cancer

Article

Author: Li, Mingjian ; Xie, Yuanzhu ; Chen, Ling ; Hu, Xiyuan ; Liu, Li ; Luo, Zhiyong ; Luo, Tiao ; Ye, Junfeng ; Sui, Zhongtai ; Nie, Caiyun ; Ma, Dayou ; Liu, Xiaohe ; Huang, Xinyu ; Li, Yao ; Deng, Xu ; Liu, Suyou ; Ni, Shuang ; Zhu, Xinyu

Triple-negative breast cancer (TNBC) remains a clinical challenge due to limited treatment options and drug resistance. Signal transducer and activator of transcription 3 (STAT3) is a promising therapeutic target for TNBC, as its hyperactivation drives tumor progression. Here, we report the design and synthesis of a novel series of isoxazole quinone derivatives targeting the STAT3 SH2 domain. Among these, B16 demonstrated exceptional potency, with IC₅₀ values of 70 nM against TNBC cell lines (MDA-MB-231 and MDA-MB-468), representing a 10-fold improvement over napabucasin. Mechanistic studies revealed that B16 directly binds to the STAT3 SH2 domain, suppresses STAT3 phosphorylation and nuclear translocation, and inhibits colony formation, migration and invasion of TNBC cells. In vivo, B16 (10 mg/kg) reduced tumor volume by 82 % in a MDA-MB-231 xenograft model, outperforming napabucasin (50 % reduction in tumor volume), with no significant toxicity observed. These findings established B16 as a highly potent STAT3 inhibitor, offering a promising therapeutic strategy for TNBC.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Brigimadlin (BI-907828) and napabucasin (BBI608) cooperatively trigger apoptosis in chronic lymphocytic leukemia cells by simultaneous inhibition of MDM2 and STAT3

Article

Author: Aptullahoglu, Erhan

BACKGROUND:

Chronic lymphocytic leukemia (CLL) remains largely incurable, particularly in elderly or treatment-resistant patients. Although MDM2 inhibitors restore p53-mediated apoptosis in p53-functional CLL, single-agent activity is limited by resistance mechanisms. Signal transducer and activator of transcription 3 (STAT3) signaling also promotes CLL survival and immune evasion, suggesting that concurrent blockade of both pathways may enhance cell death.

METHODS AND RESULTS:

Here, the synergistic potential of the oral MDM2 antagonist BI-907828 (brigimadlin) and the STAT3 inhibitor BBI608 (napabucasin) was evaluated in two CLL cell lines with distinct TP53 (Tumor Protein p53, the gene encoding p53 protein) status: p53-wild-type EHEB and p53-mutant/17p-deleted MEC-1. Monotherapy with BI-907828 induced marked p53 stabilization, upregulation of p21^WAF1, PARP cleavage, and caspase-3/7 activation in EHEB cells, whereas MEC-1 cells remained unresponsive. BBI608 alone reduced cell viability in both lines in a dose-dependent manner, with its effect in MEC-1 cells suggesting a p53-independent mechanism. When combined, BI-907828 and BBI608 synergistically enhanced apoptotic markers in EHEB cells (δ synergy score > 17) but elicited no synergy in MEC-1, underlining the requirement for intact p53.

CONCLUSION:

These findings establish a mechanistic rationale for the concurrent targeting of the MDM2 and STAT3 axes and provide preclinical evidence for a promising, non-genotoxic therapeutic strategy in p53-functional CLL. A limitation of this study is the lack of in vivo validation and clinical data, which are necessary to further assess the safety, optimal dosing, and efficacy, particularly in elderly or unfit patients with limited treatment options.

News (Medical) associated with Napabucasin

05 Oct 2023

·synapse.patsnap.com

Tumor Killers: STAT3 inhibitors

Signal transducer and activator of transcription (STAT) is a class of proteins with dual functions of cytoplasmic signal transduction and nuclear transcription activation, widely found in mammalian cells, mediating a variety of intracellular signal pathways. Although STAT family members are highly homologous, their functions are vastly diverse. STAT3 is a signaling molecule expressed in various tissues. STAT3 can be activated by various factors, including cytokines, growth factors, neuroendocrine factors, ischemic hypoxic stimuli, etc. As a functionally diversified transcription factor, STAT3 can interact with a large number of signal molecules and forms various intra- and extracellular signal pathways. STAT3 is involved in a variety of biological processes, including cell proliferation, survival, differentiation and angiogenesis. In normal cells, STAT3 is transiently activated by phosphorylation to transmit the transcription signals of cytokine and growth factor receptors on the plasma membrane to the nucleus. Studies have shown that persistently activated STAT3 is essential for various cancers, such as breast cancer and colorectal cancer, making STAT3 an ideal drug target. However, STAT3 becomes excessively activated in most human cancers, usually associated with poor clinical prognosis. Through signal transduction and transcription activation, STAT3 participates in complex and varied life activities in biological bodies and is a current research hotspot. The research on STAT3 in the field of tumors has already achieved staged results. As the convergence point of multiple tumor pathways, STAT3 is persistently highly expressed in tumor cells and can promote tumor cell proliferation, resist cell apoptosis, mediate oncogenic inflammation, and inhibit anti-tumor immunity, etc. STAT3 has become an important molecular target for tumor treatment to a certain extent! STAT3 Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 25 Sep 2023, there are a total of 85 STAT3 drugs worldwide, from 92 organizations, covering 103 indications, and conducting 161 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of the current competitive landscape and future development of target STAT3 reveals that multiple companies are actively involved in the research and development of drugs targeting this specific target. The highest stage of development is the approved stage, with companies like Verta, Inc., Beijing Union Pharmaceutical Factory, and Sumitomo Chemical Co., Ltd. leading the way. Neoplasms and hepatocellular carcinoma are among the indications with approved drugs. Small molecule drugs are progressing rapidly, followed by antisense oligonucleotides, AAV-based gene therapy, and PROTACs. China, the United States, and various countries in the European Union are developing rapidly under the target STAT3. Further analysis is required to understand the competition around innovative drugs and the research and development institutions involved in biosimilars. Overall, the target STAT3 shows promising potential for the development of new drugs in the pharmaceutical industry. STAT3 inhibitors entering into Phase III clinical trials: NapabucasinNapabucasinis a small molecule drug that targets STAT3, a protein involved in various cellular processes, including cell growth and survival. It has shown potential therapeutic benefits in several therapeutic areas, including neoplasms, digestive system disorders, nervous system diseases, endocrinology and metabolic diseases, and respiratory diseases. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. In terms of specific indications, Napabucasin has demonstrated activity against pancreatic cancer, pancreatic ductal carcinoma, non-small cell lung cancer, colorectal cancer, stomach cancer, esophageal carcinoma, glioblastoma, hepatocellular carcinoma, gastrointestinal neoplasms, and liver cancer. These indications cover a wide range of cancers affecting different organs and systems in the body. The drug is developed by Pharmaceutics International, Inc., an originator organization in the pharmaceutical industry. It has reached Phase 3 of clinical development globally and in China. Phase 3 trials are the final stage of clinical development before seeking regulatory approval. Napabucasin has been designated as an orphan drug, indicating that it is intended to treat rare diseases or conditions. This regulatory status provides certain incentives and benefits to the drug's developer, such as market exclusivity and financial incentives, to encourage the development of treatments for rare diseases. Based on the available information, Napabucasin shows promise as a potential treatment for various types of cancer and other diseases. However, further clinical trials and regulatory approvals are necessary to establish its safety and efficacy. The drug's specific mechanism of action, potential side effects, and other relevant details are not provided in the given information. Therefore, a comprehensive analysis of the drug's potential and its competitive landscape would require additional data and research. STAT3 inhibitors entering into Phase II clinical trials: DanvatirsenDanvatirsen is an antisense oligonucleotide drug that targets STAT3, a protein involved in various cellular processes, including cell growth and survival. It is being developed by Ionis Pharmaceuticals, Inc. and has reached Phase 2 of clinical trials, both globally and in China. The therapeutic areas targeted by Danvatirsen include neoplasms (abnormal growth of cells), immune system diseases, hemic and lymphatic diseases, digestive system disorders, endocrinology and metabolic diseases, skin and musculoskeletal diseases, respiratory diseases, urogenital diseases, and other diseases. This broad range of therapeutic areas suggests that Danvatirsen has the potential to be used in the treatment of various conditions. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The drug's active indications include recurrent squamous cell carcinoma of the head and neck, squamous cell carcinoma of head and neck metastatic, triple-negative breast cancer, bladder cancer, non-small cell lung cancer, pancreatic cancer, colorectal cancer, head and neck neoplasms, ascites (abnormal accumulation of fluid in the abdomen), hepatocellular carcinoma (liver cancer), non-Hodgkin lymphoma, and diffuse large B-cell lymphoma. As an antisense oligonucleotide, Danvatirsen works by binding to the messenger RNA (mRNA) molecules that carry the instructions for producing STAT3 protein. By binding to these mRNA molecules, Danvatirsen prevents the production of STAT3 protein, thereby inhibiting its activity. This approach offers a targeted and specific way to interfere with the function of STAT3, which is known to play a role in the development and progression of various cancers. The fact that Danvatirsen has reached Phase 2 of clinical trials indicates that it has shown promising results in earlier stages of testing, such as Phase 1 trials. Phase 2 trials involve a larger number of participants and aim to further evaluate the drug's safety and effectiveness. The inclusion of China in the highest phase of development suggests that Ionis Pharmaceuticals, Inc. recognizes the potential market and demand for Danvatirsen in this country. In summary, Danvatirsen is an antisense oligonucleotide drug developed by Ionis Pharmaceuticals, Inc. that targets STAT3. It has shown potential in a wide range of therapeutic areas, particularly in the treatment of various cancers. With its current highest phase being Phase 2, Danvatirsen is undergoing further evaluation to determine its safety and effectiveness.

21 Dec 2022

·www.prnewswire.com

Gastric Cancer Pipeline Space Brims With Novel Emerging Therapies with Over 200 Key Companies Working in the Domain | DelveInsight

The prevalence of gastric cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Gastric Cancer drive the market. The companies developing the potential therapies in the last stage of development include Henlix Biotech, Eli Lilly and Company, Jiangsu Hengrui Medicine, and several others. LAS VEGAS, Dec. 21, 2022 /PRNewswire/ -- DelveInsight's ' Gastric Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline gastric cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the gastric cancer pipeline domain. Key Takeaways from the Gastric Cancer Pipeline Report DelveInsight's gastric cancer pipeline report depicts a robust space with 200+ active players working to develop 230+ pipeline therapies for gastric cancer treatment. Key gastric cancer companies such as EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others are evaluating new gastric cancer drugs to improve the treatment landscape. Promising gastric cancer pipeline therapies in various stages of development include Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. In December 2022, Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In December 2022, RemeGen Co., Ltd. announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been twice granted ODD for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Zhejiang Doer Biologics Co., Ltd. announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to investigate Doer Bio's anti-Claudin18.2 antibody DR30303, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with Gastric or Gastroesophageal Junction Cancer. Under this agreement, Doer Bio will conduct a clinical study based on a mutually- agreed and finalized protocol to evaluate the safety and efficacy of DR30303 in combination with KEYTRUDA® in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer. In November 2022, Triumvira Immunologics announced preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.Triumvira announced updated data on its novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) for the treatment of gastric cancer. The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo. The study also demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. In vitro data show strong and persistent anti-tumor activity and in vivo treatment led to complete and sustained tumor clearance with no signs of toxicity. In September 2022, Nuvectis Pharma, Inc. announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma.Mice in each group were treated with either vehicle or NXP800, and tumor volumes were measured over 28 days. Treatment with NX800 resulted in tumor regression and substantial tumor growth inhibition versus the control. In March 2022, Imugene (ASX: IMU) announced a new clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate the safety and efficacy of Imugene's HER-Vaxx, B-cell activating immunotherapy, in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients with HER-2 positive gastric cancer. Request a sample and discover the recent advances in gastric cancer drug treatment @ Gastric Cancer Pipeline Report The gastric cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage gastric cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the gastric cancer clinical trial landscape. Gastric Cancer Overview Stomach cancer is cancer that begins within the stomach or on the stomach wall. It is also known as gastric cancer. Stomach cancer is more common in the elderly. People aged 75 and above account for approximately 50 out of every 100 cases (around 50%). It affects men more than women. The exact gastric cancer causes are not known. Stomach cancer is linked to Helicobacter pylori, a bacteria that lives in the stomach. The most common gastric cancer symptoms are difficulty swallowing (dysphagia), weight loss, persistent indigestion (dyspepsia), feeling full after eating small amounts, feeling or being sick, and fatigue due to low red blood cell count (anaemia). Several tests, such as ultrasound, imaging tests, blood tests, and others, are used for gastric cancer diagnosis. Gastric cancer patients can receive a variety of treatments. Standard gastric cancer treatment consists of seven types: surgery, endoscopic mucosal resection, chemotherapy, radiation therapy, chemoradiation, targeted therapy, and immunotherapy. Find out more about chemotherapy drugs for gastric cancer @ New Gastric Cancer Drugs A snapshot of the Gastric Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging gastric cancer pipeline therapies @ Gastric Cancer Clinical Trials Gastric Cancer Therapeutics Assessment The gastric cancer pipeline report proffers an integral view of gastric cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Gastric Cancer 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, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Macrophage stimulants, Natural killer cell stimulants, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, Angiogenesis inhibitors, Epidermal growth factor receptor antagonists, EIF 2 kinase inhibitors Key Gastric Cancer Companies: EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others. Key Gastric Cancer Pipeline Therapies: Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. Dive deep into rich insights for new drugs for gastric cancer treatment; visit @ Gastric Cancer Medications Table of Contents For further information on the gastric cancer pipeline therapeutics, reach out @ Gastric Cancer Drug Treatment Related Reports Gastric Cancer Epidemiology Forecast Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the gastric cancer epidemiology trends. Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, among others. HER2+ Gastric Cancer Market HER2+ Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Pipeline HER2+ Gastric Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Epidemiology HER2+ Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the HER2+ gastric cancer epidemiology trends. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugDrug Approval

07 Feb 2021

·www.prnewswire.com

Sumitomo Dainippon Pharma Oncology Announces Phase 3 CanStem303C Study of Napabucasin Fails to Reach Primary Endpoints in Patients with Previously Treated Metastatic Colorectal Cancer

CAMBRIDGE, Mass., Feb. 9, 2021 /PRNewswire/ -- Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, today announced that the CanStem303C study evaluating the efficacy and safety of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with previously treated metastatic colorectal cancer failed to reach the primary endpoints of overall survival (OS). Napabucasin in combination with FOLFIRI failed to show significant OS improvement in the general study population and in patients whose tumor was positive for the phosphorylated signal transducer and activator of transcription 3 (pSTAT3) biomarker. "Patients with metastatic colorectal cancer have a high unmet medical need, and our hope was to develop a new treatment option for this population. We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial participants, investigators and staff for their efforts and contributions to the study," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer." The multicenter, open-label, randomized Phase 3 CanStem303C study evaluated the efficacy and safety of napabucasin in approximately 1,250 patients with previously treated metastatic colorectal cancer. Patients were randomized 1:1 in the study. The study had two primary endpoints – overall survival in all randomized patients and overall survival in a subpopulation of patients whose tumor was positive for the pSTAT3 biomarker. Napabucasin at a dose of 240 mg was administered orally, twice daily in combination with FOLFIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab. The most common adverse events, occurring in patients in the napabucasin combination arm, were consistent with previously published data and included diarrhea, nausea, vomiting and abdominal pain. Final data and analyses of this study will be published for the oncology community. About Napabucasin Napabucasin is an investigational, orally administered reactive oxygen species (ROS) generator that is bioactivated by the intracellular antioxidant NAD(P)H:quinone oxidoreductase 1 (NQO1).1 Napabucasin exerts its antitumor activity by increasing levels of ROS beyond a cytotoxic threshold, causing cancer cell death.1,2 About Colorectal Cancer Colorectal cancer is the third leading cause of cancer-related deaths in men and in women in the U.S. It is estimated that there will be 149,500 new cases of colorectal cancer and 52,980 deaths from colorectal cancer in the U.S. this year.3 Metastatic colorectal cancer occurs when cancer cells break way from a tumor in the colon or the rectum to other parts of the body through the bloodstream or lymphatic system.4 Approximately 22% of colorectal cancer cases are metastatic at initial diagnosis, and about 70% of patients will eventually develop metastatic relapse. Patients with metastatic colorectal cancer face poor prognosis in general, with a relative 5-year survival rate of 14%, compared to 71% and 90% in those with regional and localized colorectal cancer in the U.S.5 About Sumitomo Dainippon Pharma Oncology Sumitomo Dainippon Pharma Oncology, Inc., is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SDP Oncology is relentlessly committed to advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. The company's robust and diverse pipeline of preclinical and advanced-stage assets spans multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions, which aim to address unmet clinical needs in oncology. For more information, visit . About Sumitomo Dainippon Pharma Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at . Disclaimer Regarding Forward-Looking Statements This press release contains "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available and involve both known and unknown risks and uncertainties. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. References Chang AY, Hsu E, Patel J, et al. Evaluation of tumor cell-tumor microenvironment component interactions as potential predictors of patient response to napabucasin. Mol Cancer Res. 2019;17(7):1429-1434. Froeling F, Swamynathan MM, Deschênes A, et al. Bioactivation of napabucasin triggers reactive oxygen species-mediated cancer cell death. Clin Cancer Res . 2019;25(23):7162-7174. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, Ga : American Cancer Society; 2021. Cancer Treatment Centers of America. Metastatic Colorectal Cancer . Updated September 18, 2020 . Accessed January 25, 2021 . Wang J, Li S, Liu Y, Zhang C, Li H, Lai B. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population-based analysis. Cancer Med. 2020;9(1):361-373. SOURCE Sumitomo Dainippon Pharma Oncology, Inc. Related Links

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma, metastatic	Phase 3	China	1globe Health Institute LLC	25 Apr 2022
Adenocarcinoma, metastatic	Phase 3	Canada	1globe Health Institute LLC	25 Apr 2022
Adenocarcinoma, metastatic	Phase 3	France	1globe Health Institute LLC	25 Apr 2022
Adenocarcinoma, metastatic	Phase 3	Spain	1globe Health Institute LLC	25 Apr 2022
Metastatic Pancreatic Cancer	Phase 3	China	1Globe Biomedical Co Ltd	25 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	China	1globe Health Institute LLC	25 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	China	Pharmaceutics International, Inc.	25 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	France	1globe Health Institute LLC	25 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	Spain	1globe Health Institute LLC	25 Oct 2018
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	Spain	Boston Biomedical, Inc.	04 Apr 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02358395 (Pubmed)	Phase 1	Unresectable Hepatocellular Carcinoma	6	Napabucasin (480 mg/day) plus Sorafenib (800 mg/day)	heqfzesouj(jwfjvcbmxq) = stable disease melgsfcvbf (tcowzjzhki )	-	15 May 2023
NCT01325441 (CTgov)	Phase 1/2	Primary peritoneal carcinoma \| Adenosquamous Carcinoma \| Solid tumor ... View more	565	Paclitaxel+Napabucasin (Napabucasin 200mg BID Plus Paclitaxel)	zrwvjxuzyy = lbikshxkxn plqgqxkbsw (ktsnttjmns, ozjuogsxpc - fkzbyhsfwb) View more	-	03 Feb 2023
				Paclitaxel+Napabucasin (Napabucasin 240mg BID Plus Paclitaxel)	zrwvjxuzyy = hwuezraeih plqgqxkbsw (ktsnttjmns, dsjjytoopy - yzskrpvhjk) View more
NCT02753127 (CanStem303C, CTgov)	Phase 3	Metastatic Colorectal Carcinoma	1,253	Bevacizumab+Napabucasin (Napabucasin + FOLFIRI ± Bevacizumab)	rwkzoekxor(bypyeeqxgu) = pcndrarjzw ylqafykhap (nloxqfyxyw, swqwzacuul - gkrilizfeb) View more	-	26 Apr 2022
				Bevacizumab (FOLFIRI ± Bevacizumab)	rwkzoekxor(bypyeeqxgu) = elgyzozash ylqafykhap (nloxqfyxyw, nlqkbagbge - ndphzsnvih) View more
NCT02641873 (Pubmed \| Int J Clin Oncol) Manual	Phase 1	Metastatic Colorectal Carcinoma	4	bevacizumab+fluorouracil+leucovorin+irinotecan+napabucasin	ytwktbstoh(ybtufwipic) = All four patients experienced diarrhoea and decreased appetite (considered napabucasin-related in four and two patients, respectively), and three patients experienced neutrophil count decreased szpppphuer (qdnfhqjhlk )	Positive	01 Nov 2021
NCT02347917 (CTgov)	Phase 1/2	Malignant Pleural Mesothelioma \| Non-Small Cell Lung Cancer	28	Pem+CDDP+BBI608 (MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part))	oqrmezahhg = nrnadyejut ectmghocmv (eszhpcuhip, idonpaquyd - ohcxfjykqf) View more	-	01 Oct 2021
				Pem+CDDP+BBI608 (MPM: BBI608 + Pem + CDDP (Phase 2 Part))	gkbxxsbxiq(bxstbdzoss) = fllbgtqajl evlergjqif (xarzdkzass, ythlynnhle - rbyqwsbpng) View more
NCT02315534 (BBI608-201GBM, CTgov)	Phase 1/2	Recurrent Glioblastoma	34	TMZ+BBI608 (Candidates Whom Surgery is Recommended.)	yjcjkixywl = xgqubtluro rysqohuggt (wnivheehhh, plklyezmkh - uaafbgvhqa)	-	24 Sep 2021
				TMZ+BBI608 (Candidates Whom Surgery is Not Recommended)	yjcjkixywl = rbxujltnbi rysqohuggt (wnivheehhh, ripfiwvmjv - zwyxteuziy) View more
NCT02024607 (CTgov)	Phase 1/2	Gastrointestinal Neoplasms	495	FOLFOX6+Napabucasin (Napabucasin Plus FOLFOX6)	gerprvhvth = pgvyrnklrz ooxdywcwbb (ckentaduvy, sguzrppodn - uatlvypzeu) View more	-	20 Sep 2021
				FOLFOX6+Bevacizumab+Napabucasin (Napabucasin Plus FOLFOX6 Plus Bevacizumab)	gerprvhvth = yhvqsguyux ooxdywcwbb (ckentaduvy, ozsxnmbrxd - tzsqnqocha) View more
NCT02993731 (CanStem111P, ESMO 12021 \| ESMO 22021) Manual	Phase 3	Pancreatic adenocarcinoma metastatic First line	-	nab-paclitaxel+gemcitabine+napabucasin (GSP: napabucasin)	tjrckqdslt(emhoxoquac) = kknbmaqksa maauwzyhet (wgidnguaay ) View more	Negative	16 Sep 2021
				nab-paclitaxel+gemcitabine (GSP: CTL)	tjrckqdslt(emhoxoquac) = ljsigqkegf maauwzyhet (wgidnguaay ) View more
NCT02753127 (CanStem303C, ESMO_GI2021)	Phase 3	Metastatic Colorectal Carcinoma pSTAT3+	1,253	FOLFIRI + napabucasin 240 mg oral, twice daily	zsdxyzwlbp(vzrldpxakg) = ritgeupcvd epmeztuvtm (hzptrhpvjr )	Negative	03 Jul 2021
				FOLFIRI	zsdxyzwlbp(vzrldpxakg) = mqqpkjwqgm epmeztuvtm (hzptrhpvjr )
NCT01776307 (BBI608-224, CTgov)	Phase 2	Advanced Colorectal Adenocarcinoma	200	Cetuximab+Napabucasin (Napabucasin Plus Cetuximab)	genfxfqkvx = qgwrkolwbx ovcayeisgv (fkpcwmdcjj, ivfzuktbwq - glkpfnjsbz) View more	-	18 Jun 2021
				Napabucasin+Panitumumab (Napabucasin Plus Panitumumab)	genfxfqkvx = itkjkykpap ovcayeisgv (fkpcwmdcjj, ziyzaawved - bbpnczsopm) View more

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