This phase I trial studies the side effects and best dose of MORAb-004 in treating young patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them

Start Date01 Nov 2013

Sponsor / Collaborator

Morphotek, Inc.

[+2]

JPRN-jRCT2080222023

/ Unknown statusPhase 1

A phase 1 study of MORAb-004 in patients with solid tumor

Start Date19 Feb 2013

Sponsor / Collaborator

Eisai Co., Ltd.

NCT01773434

/ CompletedPhase 1

A Phase 1 Study of MORAb-004 in Patients With Solid Tumor

This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with solid tumors. Subjects may have any solid tumor without intracranial involvement or metastases that has failed standard chemotherapy.
This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle with no intra-subject escalation. Individual participants may have additional cycles at the same dose until disease progression unless the participants meet the discontinuation criteria.
2) Part 2 will comprise cohort expansions to further characterize the safety and tolerability of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose levels will be expanded based on the safety profile that was obtained in the dose escalation portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).

Start Date01 Dec 2012

Sponsor / Collaborator

Eisai Co., Ltd.

100 Clinical Results associated with Ontuxizumab

100 Translational Medicine associated with Ontuxizumab

100 Patents (Medical) associated with Ontuxizumab

Literatures (Medical) associated with Ontuxizumab

23 Apr 2025·APPLIED AND ENVIRONMENTAL MICROBIOLOGY

Microbial magnetite oxidation via MtoAB porin-multiheme cytochrome complex in Sideroxydans lithotrophicus ES-1

Article

Author: Yu, Yanbao ; Keffer, Jessica L. ; Chan, Clara S. ; Zhou, Nanqing ; Rushworth, Danielle D.

ABSTRACT:

Most of Earth’s iron is mineral-bound, but it is unclear how and to what extent iron-oxidizing microbes can use solid minerals as electron donors. A prime candidate for studying mineral-oxidizing growth and pathways is Sideroxydans lithotrophicus ES-1, a robust, facultative iron oxidizer with multiple possible iron oxidation mechanisms. These include Cyc2 and Mto pathways plus other multiheme cytochromes and cupredoxins, and so we posit that the mechanisms may correspond to different Fe(II) sources. Here, S. lithotrophicus ES-1 was grown on dissolved Fe(II)-citrate and magnetite. S. lithotrophicus ES-1 oxidized all dissolved Fe 2+ released from magnetite and continued to build biomass when only solid Fe(II) remained, suggesting it can utilize magnetite as a solid electron donor. Quantitative proteomic analyses of S. lithotrophicus ES-1 grown on these substrates revealed global proteome remodeling in response to electron donor and growth state and uncovered potential proteins and metabolic pathways involved in the oxidation of solid magnetite. While the Cyc2 iron oxidases were highly expressed on both dissolved and solid substrates, MtoA was only detected during growth on solid magnetite, suggesting this protein helps catalyze oxidation of solid minerals in S. lithotrophicus ES-1. A set of cupredoxin domain-containing proteins were also specifically expressed during solid iron oxidation. This work demonstrated that the iron oxidizer S. lithotrophicus ES-1 utilized additional extracellular electron transfer pathways when growing on solid mineral electron donors compared to dissolved Fe(II).

IMPORTANCE:

Mineral-bound iron could be a vast source of energy to iron-oxidizing bacteria, but there is limited physiological evidence of this metabolism, and it has been unknown whether the mechanisms of solid and dissolved Fe(II) oxidation are distinct. In iron-reducing bacteria, multiheme cytochromes can facilitate iron mineral reduction, and here, we link a multiheme cytochrome-based pathway to mineral oxidation, expanding the known functionality of multiheme cytochromes. Given the growing recognition of microbial oxidation of minerals and cathodes, increasing our understanding of these mechanisms will allow us to recognize and trace the activities of mineral-oxidizing microbes. This work shows how solid iron minerals can promote microbial growth, which, if widespread, could be a major agent of geologic weathering and mineral-fueled nutrient cycling in sediments, aquifers, and rock-hosted environments.

01 Feb 2025·Natural product research

Absolute configurations of biantraquinones from Eremurus spectabilis BIEB

Article

Author: Koldas, Serkan

This report covers extraction, isolation, and characterisation studies on Eremurus spectabilis BIEB (Liliaceae) species. Eremurus spectabilis BIEB was extracted with hexane, chloroform, ethyl acetate, and methanol, respectively. Using chromatographic methods, two known bianthraquinones (ES3, 7,10'-bichrysophanol and ES6, chrysalodin), three known anthraquinones (ES1, chrysophanol; ES2, chrysophanol-8-methyl ether; ES4, aloe emodin) and one known steroidal compound (ES5, daucosterol) were isolated from the chloroform extract. Structures of these isolated compounds were revealed by 1D and 2D NMR and HRMS spectroscopies. Absolute configurations of ES3 and ES6 were determined by single crystal X-Ray diffraction analysis.

31 Dec 2024·Gut microbes

A randomized double-blind, placebo-controlled trial to evaluate the safety and efficacy of live Bifidobacterium longum CECT 7347 (ES1) and heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) in participants with diarrhea-predominant irritable bowel syndrome

Article

Author: Kumar, S ; Parihar, R ; Day, R ; Vijayakumar, V ; Jadon, P S ; Khanna, S ; Pandit, A ; Naghibi, M ; Patel, J ; Dargad, R R ; Srivastava, S ; Basak, U

To determine the efficacy of the probiotic Bifidobacterium longum CECT 7347 (ES1) and postbiotic heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) in improving symptom severity in adults with diarrhea-predominant irritable bowel syndrome (IBS-D), a randomised, double-blind, placebo-controlled trial with 200 participants split into three groups was carried out. Two capsules of either ES1, HT-ES1 or placebo were administered orally, once daily, for 84 days (12 weeks). The primary outcome was change in total IBS-Symptom Severity Scale (IBS-SSS) score from baseline, compared to placebo. Secondary outcome measures were stool consistency, quality of life, abdominal pain severity and anxiety scores. Safety parameters and adverse events were also monitored. The change in IBS-SSS scores from baseline compared to placebo, reached significance in the ES1 and HT-ES1 group, on Days 28, 56 and 84. The decrease in mean IBS-SSS score from baseline to Day 84 was: ES1 (-173.70 [±75.60]) vs placebo (-60.44 [±65.5]) (p < .0001) and HT-ES1 (-177.60 [±79.32]) vs placebo (-60.44 [±65.5]) (p < .0001). Secondary outcomes included changes in IBS-QoL, APS-NRS, stool consistency and STAI-S and STAI-T scores, with changes from baseline to Day 84 being significant in ES1 and HT-ES1 groups, compared to the placebo group. Both ES1 and HT-ES1 were effective in reducing IBS-D symptom severity, as evaluated by measures such as IBS-SSS, IBS-QoL, APS-NRS, stool consistency, and STAI, in comparison to the placebo. These results are both statistically significant and clinically meaningful, representing, to the best of the authors' knowledge, the first positive results observed for either a probiotic or postbiotic from the same strain, in this particular population.

News (Medical) associated with Ontuxizumab

21 Mar 2024

·synapse.patsnap.com

GPCR Targets and Pipeline at the JP Morgan Healthcare Conference 2024 (5)

In this article, we will focus on Sosei Heptares, a leading company in the field of GPCR new drug development, and its GPCR research and development pipeline. For more details, please follow the link below. GPCR Targets and Pipeline at the JP Morgan Healthcare Conference 2024 (1)GPCR Targets and Pipeline at the JP Morgan Healthcare Conference 2024 (2)GPCR Targets and Pipeline at the JP Morgan Healthcare Conference 2024 (3)GPCR Targets and Pipeline at the JP Morgan Healthcare Conference 2024 (4)Sosei Heptares in JPM 2024Sosei Heptares is a biopharmaceutical company based in Japan with operations spanning the Asia-Pacific region, focused on structure-based drug design (SBDD), particularly in the area of G protein-coupled receptors (GPCRs). The company has over 30 active research and development projects involving central nervous system disorders, immunology, gastrointestinal diseases, and various other therapeutic areas. Its marketed product, PIVLAZ®, is widely used in Japan and South Korea, where it has been approved for use. Over the past 20 years, Sosei has undergone several rounds of acquisitions and restructurings and completed a significant transformation in 2023, including the acquisition of Idorsia Pharmaceuticals' operations in Japan and the Asia-Pacific region and securing significant investments from government funds. Additionally, the company has collaborated with several top global pharmaceutical companies, making clinical advancements in the treatment of metabolic and neuropsychiatric disorders such as insomnia. Daridorexant is expected to be launched in Japan by the end of 2024. In 2023, Sosei Heptares has implemented a series of corporate actions and investments to drive future growth. The company's internal research projects, including PIVLAZ®, daridorexant, HTL-149 (a GPR52 agonist), and HTL-723, have achieved milestone progress. Moreover, Sosei Heptares and its partners launched multiple clinical programs in 2023, involving the research and development of several innovative therapies for metabolic and neuropsychiatric disorders. This includes a range of novel cholinergic M4 and M1/M4 agonists being developed in collaboration with Neurocrine for the study of schizophrenia and other neuropsychiatric diseases, with some drugs nearing or having entered the late clinical phase. The company's first commercially available medicine, PIVLAZ® (a selective ETA receptor antagonist), has made a significant impact on stroke treatment in Japan and has been accumulating evidence in the real world. PIVLAZ® is recommended by the Japan Stroke Society and has proven to have a definitive therapeutic effect on subarachnoid hemorrhage (SAH), preventing delayed cerebral ischemia and adverse outcomes with a high level of evidence, thus strengthening the confidence of neurosurgeons in prescribing the medication. Additionally, the drug has received market approval in Korea and is planned to start sales to patients at the beginning of 2025. By the end of 2023, the company has submitted a New Drug Application (NDA) in Japan for daridorexant for the treatment of insomnia, with an anticipated launch in the Japanese market in the fourth quarter of 2024. The drug is expected to make a significant contribution to Japanese society. Insomnia causes an estimated annual economic loss of up to 15 trillion yen in Japan (approximately 3% of GDP), and results in the loss of 604,000 working days due to absenteeism and medical leave. Moreover, individuals averaging less than 6 hours of sleep per night face an increased mortality risk by 10%. Daridorexant, a dual orexin receptor antagonist, is already on the market in the United States and Europe under the brand name QUVIVIQ™. Joint development and co-marketing plans for daridorexant in Japan are currently underway, with expectations to effectively address the issue of insomnia. Sosei Heptares employs Artificial Intelligence (AI) and Machine Learning (ML) technologies in various drug development processes to enhance the efficiency of drug discovery, including receptor preparation technology (StaR®), protein structure, molecular design, and translational medicine. Utilizing the StaR® technology in combination with AI/ML algorithms, the company mines datasets rich in GPCR mutations to predict and accelerate the generation of StaR® variants conducive to stabilizing GPCR structures, thereby hastening the drug discovery process. Additionally, AI technology is used to analyze GPCR binding sites and patterns, enhancing the accuracy of GPCR homology models to support drug molecule optimization and virtual screening efforts. Hit identification is conducted based on internal and external structural databases, while drug molecule designs are optimized using ML QSAR models derived from internal and public datasets. Moreover, AI is applied to analyze large patient datasets to identify biomarkers and stratify patients, ensuring more precise and effective clinical trial designs. The application of these advanced technologies not only aids in the identification of new chemical series but also enhances the optimization of existing chemical series, improving drug properties with the goal of developing more life-changing medicines. The company possesses several internally researched and collaboratively developed GPCR (G protein-coupled receptor) new drug development pipelines, which are at various stages of research and development. These pipelines encompass multiple therapeutic areas including metabolic diseases, inflammatory bowel disease, schizophrenia and neuropsychiatric disorders, as well as solid tumors. PIVLAZ® (Clazosentan) is a potent, selective endothelin ETA receptor antagonist indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and ischemic symptoms following aneurysmal subarachnoid hemorrhage (aSAH). Pivlaz® successfully launched in Japan in April 2022 for the treatment of cerebral vasospasm. Sosei Heptares holds the rights to sell Pivlaz® in Japan and the Asia-Pacific region, excluding China. Ultibro Breezhaler is a pioneering inhaled dual bronchodilator (long-acting β2-adrenergic receptor agonist or long-acting muscarinic antagonist, LAMA/LABA), approved in more than 90 countries including the European Union and Japan. It is a once-daily fixed-dose combination formulation of indacaterol and glycopyrronium bromide, indicated in the European Union for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Daridorexant is a dual orexin receptor antagonist that blocks the binding and activity of the wakefulness-promoting neuropeptide orexin. In October 2022, daridorexant achieved positive Phase 3 clinical trial results among patients with insomnia in Japan. The success of the trial paved the way for regulatory submission in Japan in the second half of 2023. Daridorexant is approved in the United States and Europe and is marketed by Idorsia under the brand name QUVIVIQ™ in these regions. Sosei Heptares has the rights to sell daridorexant in Japan and the Asia-Pacific region (excluding China). Cenerimod is an S1PR1 modulator currently under Phase 3 clinical investigation for the treatment of systemic lupus erythematosus (SLE). Cenerimod aims to reduce autoimmune responses and control disease activity in patients with SLE by affecting lymphocyte migration. In its collaboration with Idorsia, Sosei Heptares has obtained not only the two key products, PIVLAZ® and daridorexant, but also exclusive options to license cenerimod and lucerastat, as well as selection rights for five additional projects in Idorsia's global pipeline. HTL0016878 is a selective oral small-molecule muscarinic M4 receptor agonist currently in Phase II clinical development for the treatment of schizophrenia. The mechanism of action of HTL0016878 differs from existing antipsychotic medications, and its high selectivity compared to previous non-selective muscarinic receptor agonists offers the potential for improved safety. The GPR52 agonist program is currently in Phase I clinical research, targeting schizophrenia as an indication. GPR52 is an orphan GPCR expressed in the central nervous system, implicated in neural development and regulation of the dopaminergic system. As a potential therapeutic approach, GPR52 agonists aim to ameliorate schizophrenia-related psychopathological symptoms by targeting this receptor. HTL0039732 is a novel, highly selective, and potent EP4 receptor antagonist intended for the clinical treatment of advanced solid tumors by mediating the immunosuppressive effects of PGE2 within the tumor microenvironment. In July 2022, Sosei Heptares signed an agreement with Cancer Research UK to bring Sosei Heptares' cancer immunotherapy candidate into its first human trials. Lotiglipron (PF-07081532) is an oral small-molecule GLP-1R agonist co-developed by Sosei Heptares and Pfizer. Initiated by its partner Pfizer, the Phase I clinical trial of this once-daily oral GLP-1 receptor agonist is expected to improve the metabolic status of patients with diabetes and obesity. At the end of 2022, Sosei Heptares and Pfizer announced the advancement of Lotiglipron (PF-07081532) to Phase II clinical trials. However, in June 2023, Pfizer announced the discontinuation of the clinical development of PF-07081532. At the end of November 2023, Pfizer announced the inclusion of another GLP-1R agonist, PF-06954522, developed in collaboration with Sosei Heptares, into Phase I clinical research. PF-07054894 is a selective small molecule antagonist targeting CCR6 for clinical treatment of inflammatory bowel disease (IBD). This project is also part of a collaborative research program developed with Pfizer. PF-07258669 is a selective antagonist targeting the MC4R receptor co-developed by Sosei Heptares and Pfizer, and is being clinically developed for the treatment of cachexia associated with cancer. NBI-1117570 is a dual agonist product selectively targeting the M1/M4 receptors, intended for the treatment of a variety of psychiatric disorders in the neuropsychiatric field, including but not limited to diseases related to cognition, mood, and behavior. This drug is currently in a Phase 1 clinical development study in collaboration with Neurocrine. NBI-1117569 is a selective small molecule agonist targeting the M4 receptor, while NBI-1117567 is a selective small molecule agonist targeting the M1 receptor. Both different cholinergic receptor agonists were developed using Sosei Heptares' structure-based drug design platform and are involved in neuropsychiatric indications at different stages of research. The former is in a Phase 1 clinical trial, and the latter is ready to enter Phase 1 clinical study; both drugs are being co-developed with Neurocrine. HTL0014242 (TMP-301) is a potent, selective negative allosteric modulator of the mGlu5 receptor discovered by Sosei Heptares, used for the treatment of certain neurological disorders. It is currently in a Phase 1 collaborative development by Tempero Bio for the treatment of substance abuse issues. The EP4 agonist project is currently in the preclinical research phase with indications for inflammatory bowel disease (IBD). The drug is an oral, once-daily small molecule formulation designed to modulate the prostaglandin E2 EP4 receptor subtype within the gastrointestinal tract. By activating the EP4 receptor, the medication may help to regulate immune responses and inflammation processes, thereby alleviating the symptoms of IBD patients. GSK4381406 is a GPR35 receptor agonist co-developed by Sosei Heptares and GSK for the clinical treatment of inflammatory bowel disease, currently in phase 1 clinical research. In November last year, Sosei Heptares announced that, due to GSK's strategic realignment, the company would independently continue the research on the GPR35 receptor agonist project returned by GSK. This orally administered, gut-restricted new drug has the potential to improve intestinal barrier function and reduce visceral pain sensitivity, with plans to re-initiate entry into phase 1 clinical trials.

12 Jan 2021

·www.medicalplasticsnews.com

Miniature precision bearings for dental drills

In dental air turbines, miniature rolling bearings must overcome a very demanding set of challenges. As well as rotating at speeds of up to 500,000 rpm, these bearings must provide extremely quiet operation and meet rigorous hygiene requirements. NSK offers precision miniature bearings made from stainless steel especially for this application. Driven pneumatically by a turbine wheel, the two bearings in the head of the instrument ensure stable guidance of the drill during dental procedures. Miniature bearings, which have an outer diameter of just 6.35-7mm, need to attain speeds of up to 500,000 rpm and stop very quickly. In addition, the bearings must avoid the generation of micro- vibrations and tolerate frequent cleaning and sterilisation, usually with hot, moist air in an autoclave environment. For many years NSK has been developing and manufacturing precision miniature bearings for dental air turbines. Historically, these bearings were destined exclusively for the Asian dental equipment market, but today also for Europe. Among the materials used to make the bearings is ES1, a special stainless steel developed by NSK that provides significantly increased purity and corrosion resistance compared with the commonly selected AISI 440C (equivalent to ISO 1.4125). The high purity of ES1 stainless steel has a positive effect on bearing service life, since any inclusions or structure irregularities can cause stress cracks or flaking on the bearing raceway. Using ES1 also increases corrosion resistance. The rolling elements of NSK’s miniature bearings for dental drills are made of high- performance ceramics, while the cage material is either PEEK (a high-performance plastic) or Torlon PAI (a polyamide-imides thermoplastic). All of the components used within these miniature precision bearings achieve the highest levels of accuracy. This outcome applies equally to the reproducibility of the ball diameter as it does to the surface quality (roughness) of the raceway, and the roundness of the raceway and cage. NSK also offers dental bearings in the highest accuracy class ABEC9 (P2) while attaining a bore diameter sorted tolerance class from 0.0025-0.00125mm, and from 0.00125-0mm. The consequence: NSK bearings produce significantly less micro-vibration and emit less noise than comparable bearings from other manufacturers. These characteristics derive from factors such as considerable investment and research in production technology, as well as the development of dedicated test and measurement processes for the various bearing sizes and types. NSK's range of precision miniature bearings for dental air turbines includes four series of deep groove ball bearings and angular contact ball bearings, with more than 40 different types and sizes. Along with typical external diameters of 6.35-7mm, the bearings have a typical bore diameter of 3mm for widths of 2.3-2.8mm, while the lubricant is CF1, a low- viscosity, high-performance oil.

05 Jan 2021

·www.biospace.com

Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs

TOKYO and CAMBRIDGE, England, Jan. 5, 2021 /PRNewswire/ -- Sosei Group Corporation ("the Company") (TSE: 4565) announces it is to regain the worldwide rights to its muscarinic agonist programs. The program was licensed to Allergan in April 2016, and Allergan was acquired by AbbVie in May 2020. This decision to return worldwide rights was based on business decisions regarding AbbVie's pipeline strategy and not on any efficacy, safety or other data related to the collaboration programs. As a result of this process, AbbVie has notified Sosei Heptares that it will be returning to Sosei Heptares all assets in development under the program, together with all associated intellectual property licensed by Sosei Heptares to Allergan, and all clinical and preclinical data generated under the partnership. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. The outcome of this review is expected to be reported around the time of the Company's full year results presentation in February 2021. The event reported today has no immediate impact on the consolidated financial results for the accounting period ending December 2021. Should any impacts or other matters that require an announcement be identified, the Company will announce such matters promptly. Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: "We are delighted to regain rights to this portfolio of novel subtype-selective muscarinic receptor agonists (M 4 , M 1 and dual M 1 /M 4 agonists), including several clinical and preclinical candidates with substantial data associated. We enjoyed a productive relationship with Allergan over the course of our muscarinic agonist collaboration and continue to work positively with AbbVie on a new program in inflammatory diseases that we announced in June last year. "The considerable progress that we made together with Allergan has reinforced our view in the potential of this approach to create important new products that treat severe and debilitating symptoms of Alzheimer's disease, schizophrenia and other neurological diseases. We are also encouraged by the growing industry interest and validation of this novel approach to treating these diseases. "In addition, the R&D collaboration has generated a diverse pipeline of next-generation, selective muscarinic agonists with novel chemistry that have benefitted from insights gained in clinical trials and from advanced drug design technologies. These new and differentiated candidates exhibit highly attractive properties for further development. "The value of the selective M 1 agonists was enhanced with a signal observed in early clinical trials of HTL0018318, and in addition we have been advancing the development of such agonists with novel chemistry. We will decide which selective M 1 agonist program to prioritise after further study. "We are excited by this opportunity and look forward to disclosing our strategy for the further development and re-partnering of this program at around the time of our full year results in February 2021." About the License Agreement Sosei Heptares and Allergan entered a global R&D and commercialization partnership in April 2016 under which Allergan licensed exclusive global rights to a broad portfolio of novel subtype-selective muscarinic receptor agonists (M 4 , M 1 and dual M 1 /M 4 agonists) in development for the treatment of major neurological disorders, including Alzheimer's disease. Effective 4 January 2021, the License Agreement is terminated. All intellectual property rights pertaining to the muscarinic program licensed to Allergan and subsequently added to through the collaboration, and all preclinical and clinical data, will be regained by Sosei Heptares. About Muscarinic Receptors Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues including the brain, cardiovascular system and gastrointestinal tract. Selective activation of M 4 and M 1 receptors in the brain is a clinically validated approach to treating cognitive and neuropsychological symptoms of neurological diseases, including Schizophrenia, Alzheimer's disease, Parkinson's disease and others. Until now, attempts to develop medicines that selectively target M 4 and M 1 receptors have been unsuccessful because of side effects caused by the activation of M 2 and M 3 receptors. Highly selective M 4 or M 1 agonists that do not activate M 2 or M 3 therefore are highly sought after and expected to have the potential to address major unmet medical needs with blockbuster potential. About Sosei Heptares We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We have established partnerships with some of the world's leading pharmaceutical companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Novartis, Pfizer and Takeda and additionally with multiple emerging technology companies. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK. "Sosei Heptares" is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies. For more information, please visit . LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries: Sosei Heptares – Media and Investor Relations Hironoshin Nomura, SVP Investor Relations and Corporate Strategy +81 (0)3 6679 2178 | Hironoshin.Nomura@SoseiHeptares.com Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures +81 (0)3 5210 3399 | IR@SoseiHeptares.com Citigate Dewe Rogerson Yas Fukuda – Japanese Media +81 (0)3 4360 9234 | Yas.Fukuda@citigatedewerogerson.com Mark Swallow, David Dible – International Media +44 (0)20 7638 9571 | SoseiHeptares@citigatedewerogerson.com Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. View original content: SOURCE Sosei Heptares Company Codes: Berlin:JSS, OTC-PINK:SOLTF, Tokyo:4565, Frankfurt:JSS, Munich:JSS, Stuttgart:JSS

Financial Statement

100 Deals associated with Ontuxizumab

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KEGG	Wiki	ATC	Drug Bank
-	Ontuxizumab	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Soft Tissue Sarcoma	Phase 2	United States	Morphotek, Inc.	07 Aug 2012
Metastatic Soft Tissue Sarcoma	Phase 2	Australia	Morphotek, Inc.	07 Aug 2012
Metastatic Soft Tissue Sarcoma	Phase 2	Belgium	Morphotek, Inc.	07 Aug 2012
Metastatic Soft Tissue Sarcoma	Phase 2	France	Morphotek, Inc.	07 Aug 2012
Metastatic Soft Tissue Sarcoma	Phase 2	Italy	Morphotek, Inc.	07 Aug 2012
Metastatic Soft Tissue Sarcoma	Phase 2	Netherlands	Morphotek, Inc.	07 Aug 2012
Metastatic colon cancer	Phase 2	United States	Morphotek, Inc.	27 Mar 2012
Metastatic Colorectal Carcinoma	Phase 2	United States	Morphotek, Inc.	27 Mar 2012
Metastatic melanoma	Phase 2	United States	Eisai, Inc.	16 May 2011
Metastatic melanoma	Phase 2	Australia	Eisai, Inc.	16 May 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01507545 (CTgov)	Phase 2	Metastatic colon cancer \| Metastatic Colorectal Carcinoma	154	BSC+MORAb-004 (MORAb-004 8.0 mg/kg + BSC)	tpnaotkwlf(xupevgcdrp) = ousscidzyy buxwiauymv (szznovyowb, dpjqcgfxtc - sshyqmrdlm) View more	-	06 May 2022
				Placebo (Placebo + BSC)	tpnaotkwlf(xupevgcdrp) = fykhodcoew buxwiauymv (szznovyowb, jswtkmdekc - jnmcupivlx) View more
NCT01335009 (CTgov)	Phase 2	Metastatic melanoma	76	MORAb-004 (MORAb-004 2 mg/kg)	dtkneqjodd = cpgoqjgjmy kwhocblxvc (bsyotpzafy, lyjfwivapm - bpgjaaldnz) View more	-	01 Sep 2021
				MORAb-004 (MORAb-004 4 mg/kg)	dtkneqjodd = znebnootzf kwhocblxvc (bsyotpzafy, sjqgvrnwfr - pdeqkgnqgz) View more
NCT01773434 (Pubmed) Manual	Phase 1	Solid tumor	46	ontuxizumab (dose-escalation)	kzgdxlypri(xwfvnugtfd) = khgqcaryxr zlywlxzlqw (jzcbfczkch ) View more	Positive	01 Oct 2019
				ontuxizumab (16 patients with GC and 15 with HCC)	kzgdxlypri(xwfvnugtfd) = omlqhrfxdo zlywlxzlqw (jzcbfczkch ) View more
NCT01574716 (SOURCE, CTgov)	Phase 2	Metastatic Soft Tissue Sarcoma	209	Gemcitabine+Docetaxel+MORAb-004 (Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel)	lisyxlhjwd(pgfgxyxapb) = unrzqopbla pnneavddbj (tbrusgejnr, cajjpfgczo - cgvxcnazcp) View more	-	21 Aug 2019
				Placebo+Gemcitabine+Docetaxel (Part 2: Placebo + Gemcitabine/Docetaxel)	lisyxlhjwd(pgfgxyxapb) = qwsyewscrx pnneavddbj (tbrusgejnr, qqubfdqwjh - nsieplwqzb) View more
NCT01574716 (SOURCE, Pubmed) Manual	Phase 2	Soft Tissue Sarcoma	209	gemcitabine+docetaxel+ontuxizumab	keamqyjktm(iveejszcay) = szzactljrb ujucxfnadc (vwcmqlhbeh, 2.7 - 6.3) View more	Negative	15 Jul 2019
				gemcitabine+docetaxel+Placebo	keamqyjktm(iveejszcay) = papjmrxpoa ujucxfnadc (vwcmqlhbeh, 2.6 - 8.3) View more
NCT01748721 (ADVL1213, Pubmed) Manual	Phase 1	Solid tumor	27	ontuxizumab	fwulgugmsp(idjnqqmidv) = snhbqtfpmn qfndakdhax (rvayfjnoss ) View more	Positive	01 May 2018
NCT00847054 (Pubmed \| Clin Cancer Res) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	36	MORAb-004	labndekaeb(girhrhypbi) = infusion toxicities ygtsuypjmi (thglpirhza ) View more	Positive	15 Mar 2015
ASCO2011	Phase 1	Solid tumor	23	MORAb-004 (MOR4)	dzntbggijc(bsgnkuygao) = tumor bleeding occurred at 0.5mg/kg in a pt with uterine sarcoma. Other frequent drug-related AEs included grade 1-2 fatigue, fever, chills, myalgia and headache. ybhvodirhn (ldqqbpqgug ) View more	-	20 May 2011

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