A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour

This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option.
The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.

Start Date09 Oct 2024

Sponsor / Collaborator

Synox Therapeutics Ltd.

NCT03768063

/ Active, not recruitingPhase 3

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

Start Date28 Feb 2019

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT03369964

/ WithdrawnPhase 1

A Phase Ib Study of The Safety and Pharmacology of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

This study will investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.

Start Date14 Mar 2018

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Emactuzumab

100 Translational Medicine associated with Emactuzumab

100 Patents (Medical) associated with Emactuzumab

Literatures (Medical) associated with Emactuzumab

01 Oct 2023·Hematology/oncology and stem cell therapy

Updates on the Treatment of Tenosynovial Giant Cell Tumor

Review

Author: Chan, Abigail S. ; Singh, Vikas ; Katiyar, Vatsala ; Dy, Paul

Tenosynovial giant cell tumor (TGCT) is a rare inflammatory disorder affecting the joint synovium, bursae, and tendon sheaths that causes non-specific and often insidious joint discomfort. The application of systemic chemotherapy has been limited due to poor and unsustained disease responses. Surgery with or without adjuvant radiation is the primary treatment modality for TGCT. With its locally destructive nature and increased recurrence, multiple surgical interventions become necessary throughout the course of the disease, leading to disfigurement, decreased quality of life, and increased mortality. However, owing to recent evidence demonstrating the overexpression of colony-stimulating factor 1 (CSF-1) in TGCT, selective tyrosine kinase inhibitors targeting CSF-1 receptors are being developed. Pex- idartinib is the first CSF-1 receptor inhibitor approved for the treatment of TGCT. Here, we discuss various available treatment strategies and ongoing investigations and trials targeting diffuse TGCT, which include nilotinib, lacnotuzu- mab, cabiralizumab, vimseltinib, and emactuzumab.

01 May 2022·Journal for immunotherapy of cancerQ2 · MEDICINE

Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade

Q2 · MEDICINE

ArticleOA

Author: Jean-Pascal Machiels ; Philippe Cassier ; Stephane Champiat ; Dominik Rüttinger ; Catherine Terret ; Dmitriy Zamarin ; Carl Watson ; Michael A Cannarile ; F Stephen Hodi ; Carola Ries ; Wolfgang Jacob ; Carlos Gomez-Roca ; Jose Luis Perez Gracia ; Alvaro Taus ; Francesca Michielin ; Joseph P Eder ; Randolph Christen ; Valentina Boni ; Aurelien Marabelle ; David Mcdermott ; Maria Martinez Garcia ; Sandrine Aspeslagh ; Ryan Sullivan ; Galina Babitzki ; Martin Weisser ; Konstanty Korski ; Navid Hafez ; Anna-Maria Jegg ; Georgina Meneses-Lorente ; Jean-Pierre Delord

Background:

This phase 1b study (NCT02323191) evaluated the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of colony-stimulating factor-1 receptor-blocking monoclonal antibody (mAb) emactuzumab in combination with the programmed cell death-1 ligand (PD-L1)-blocking mAb atezolizumab in patients with advanced solid tumors naïve or experienced for immune checkpoint blockers (ICBs).

Methods:

Emactuzumab (500–1350 mg flat) and atezolizumab (1200 mg flat) were administered intravenously every 3 weeks. Dose escalation of emactuzumab was conducted using the 3+3 design up to the maximum tolerated dose (MTD) or optimal biological dose (OBD). Extension cohorts to evaluate pharmacodynamics and clinical activity were conducted in metastatic ICB-naive urothelial bladder cancer (UBC) and ICB-pretreated melanoma (MEL), non-small cell lung cancer (NSCLC) and UBC patients.

Results:

Overall, 221 patients were treated. No MTD was reached and the OBD was determined at 1000 mg of emactuzumab in combination with 1200 mg of atezolizumab. Grade ≥3 treatment-related adverse events occurred in 25 (11.3%) patients of which fatigue and rash were the most common (14 patients (6.3%) each). The confirmed objective response rate (ORR) was 9.8% for ICB-naïve UBC, 12.5% for ICB-experienced NSCLC, 8.3% for ICB-experienced UBC and 5.6% for ICB-experienced MEL patients, respectively. Tumor biopsy analyses demonstrated increased activated CD8 +tumor infiltrating T lymphocytes (TILs) associated with clinical benefit in ICB-naïve UBC patients and less tumor-associated macrophage (TAM) reduction in ICB-experienced compared with ICB-naïve patients.

Conclusion:

Emactuzumab in combination with atezolizumab demonstrated a manageable safety profile with increased fatigue and skin rash over usual atezolizumab monotherapy. A considerable ORR was particularly seen in ICB-experienced NSCLC patients. Increase ofCD8 +TILs under therapy appeared to be associated with persistence of a TAM subpopulation.

01 Dec 2020·European journal of cancer (Oxford, England : 1990)Q1 · MEDICINE

Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour

Q1 · MEDICINE

Article

Author: Dominik Rüttinger ; Wolfgang Jacob ; Michael Cannarile ; Carlos Gomez-Roca ; Keelara Abiraj ; Jean-Yves Blay ; Christophe Le Tourneau ; Randolph Christen ; Philippe A. Cassier ; Carl Watson ; Irina Klaman ; Antoine Italiano ; Anna-Maria Jegg ; Maud Toulmonde ; Kristy Weber ; Sandra P. D'Angelo ; Delphine Loirat ; Martin Weisser ; Jean-Pierre Delord ; Carola H. Ries ; Francesca Michielin

OBJECTIVES:

This study investigated the safety, clinical activity and patient-reported outcomes of patients with diffuse-type tenosynovial giant-cell tumour (dTGCT) of the soft tissue who were treated with emactuzumab, a humanised anti-colony stimulating factor 1 receptor (CSF1R) monoclonal antibody and were followed up for up to 2 years after the start of treatment.

METHODS:

In this open-label phase 1 study (ClinicalTrials.govNCT01494688), patients received intravenous (IV) emactuzumab from 900 to 2000 mg every two weeks in the dose-escalation phase and at the optimal biological dose of 1000 mg with different schedules in the dose-expansion phase. Adverse event (AE) rates and biomarker assessments from tumour biopsies were analysed. Quality of life was assessed using a standard questionnaire (EuroQol-5D-3L) and the WOMAC® 3.1 Osteoarthritis Index. Tumour responses were determined with magnetic resonance imaging.

RESULTS:

Altogether, 63 patients were enrolled into the study. The most frequently reported AEs were pruritus, asthenia and oedema. In 36 patients for whom biopsy tissue was available a substantial decrease of CSF1R-positive and CD68/CD163-positive macrophages was detected. The independently reviewed best overall objective response rate (ORR) (Response Evaluation Criteria in Solid Tumors version 1.1) was 71%. Responses were durable, and an ORR of 70% and 64% was determined after one or two years after enrolment into the study. Clinical activity was accompanied by an improvement in EuroQol-5D-3L and particularly the joint disorder-specific WOMAC score.

CONCLUSIONS:

Systemic therapy of dTGCT patients with emactuzumab resulted in pronounced and durable responses associated with symptomatic improvement and a manageable safety profile.

News (Medical) associated with Emactuzumab

05 Aug 2025

·www.globenewswire.com

SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline

Top-Line Results from Study Evaluating Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT) Expected in First Quarter of 2026DUBLIN and OXFORD, United Kingdom and PHILADELPHIA, Aug. 05, 2025 (GLOBE NEWSWIRE) -- SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced completion of patient enrolment in the TANGENT study. TANGENT is the company’s global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in patients with TGCT who are not amenable to or who would not benefit from surgery. SynOx expects to report top-line data from the study in the first quarter of 2026. Emactuzumab is a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody (mAb). Clinical evaluation to date has demonstrated the compound to be a promising, next-generation mAb therapy with the potential to offer a short treatment cycle, rapid onset and long duration of response that differentiates it from chronically administered oral agents. This potentially best-in-class profile helped drive strong interest in the TANGENT trial among patients and clinical investigators across sites in the United States, Canada, Europe and Asia, leading to rapid study enrollment. “Completion of enrollment in our registrational TANGENT trial marks an important milestone for SynOx and for the TGCT community,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “We are deeply grateful to the patients, families, investigators, and clinical sites whose dedication has made this study possible and allowed SynOx to fully enroll the trial significantly ahead of our projected timeline. We remain committed, data permitting, to delivering a much-needed new treatment option for this debilitating condition.”“This is a transformational time for SynOx as we advance emactuzumab through its pivotal Phase 3 program,” said Ray Barlow, Chief Executive Officer of SynOx. “We’re excited about the next steps and look forward to delivering top-line data that we hope demonstrate how emactuzumab can transform care for patients with this grievous disease.” About the TANGENT StudyTANGENT (ClinicalTrials.gov Identifier: NCT05417789) is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT who are not amenable to or would not benefit from surgery. Patients who consent and meet eligibility criteria are randomized in a 2:1 fashion to receive either emactuzumab (1000 mg every two weeks for five doses) or matched placebo. The primary endpoint is objective response rate (ORR) as assessed by RECIST criteria at six months post-randomization. Key secondary endpoints include patient-reported outcomes (PROMIS-PF), functional assessments of range of motion, pain, stiffness, durability of response, and safety. Patients are followed for two years from randomization, with those demonstrating disease progression after the six-month assessment eligible to receive open-label emactuzumab during follow-up. About TGCTTenosynovial Giant Cell Tumour (TGCT), previously termed pigmented villonodular synovitis (PVNS), is a rare, non-malignant but aggressively growing tumour of the synovium, tendon sheaths, and bursa membranes primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease that causes loss of function of the affected joints, as well as pain, stiffness, and limited range of motion. While most patients undergo surgery, more than 50% of those with diffuse TGCT experience tumour recurrence within three years. If left untreated, TGCT can cause joint deformity, degenerative changes, and even lead to arthrodesis or amputation in severe cases. About EmactuzumabCSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor (CSF-1R), expressed on macrophages and other immune cells. Emactuzumab is a humanised IgG1 monoclonal antibody (mAb) targeting CSF-1R, designed to inhibit and deplete macrophages in tumour tissue. Originally developed by Roche, emactuzumab has shown substantial efficacy in clinical studies in TGCT, including an objective response rate of ~71%, rapid tumour reduction, functional improvement, and good tolerability with a manageable safety profile. Earlier this year, SynOx received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for emactuzumab in the treatment of TGCT, recognizing the serious unmet medical need in this condition. Emactuzumab has also received Orphan Medicinal Product designation from the European Medicines Agency. SynOx is actively exploring further development opportunities for emactuzumab in other macrophage-driven diseases. About SynOx TherapeuticsSynOx Therapeutics Limited is a Dublin, Oxford and Philadelphia-based, late-stage clinical biopharmaceutical company developing emactuzumab, a next-generation, best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, Gilde Healthcare, HealthCap, Bioqube Ventures and Medicxi. Contacts: SynOx Therapeutics Ray Barlow Chief Executive Officer Tel: +44 (0) 208 058 5619 Email: enquiries@synoxtherapeutics.com Vida Strategic Partners (on behalf of SynOx) Tim Brons (Media) 415-675-7402 tbrons@vidasp.com

Phase 3Fast TrackOrphan DrugClinical Result

14 Apr 2025

·www.globenewswire.com

SynOx Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)

DUBLIN, Ireland and OXFORD, United Kingdom, April 14, 2025 (GLOBE NEWSWIRE) -- SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to emactuzumab for the treatment of TGCT patients that are not amenable to or who would not benefit from surgery. Emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody, is currently being evaluated in the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial. TGCT is a rare, non-malignant but aggressively growing tumour of the synovium, tendon sheaths and bursa membranes primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease for patients causing loss of function of the affected joints, as well as pain, stiffness and limited range of motion. Receipt of FTD for TGCT was supported by data from Phase 1/2 clinical studies demonstrating rapid, robust tumour reduction and durable response combined with a manageable safety profile. Emactuzumab has also previously received Orphan Medicinal Project designation from the European Medicines Agency. “The granting of FTD for emactuzumab in TGCT highlights the devastating toll that this disease has on patients, as well as the critical need that remains for new treatment options,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “Based on our clinical work to date, we believe that emactuzumab has significant potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response that allows individuals suffering from TGCT to better manage their disease and move forward with their lives. We look forward to completing the ongoing TANGENT study and progressing emactuzumab toward potential commercialization.” About Fast Track DesignationThe FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track status allows for enhanced communication and collaboration between the FDA and drug developers, potentially speeding up the delivery of life-saving treatments to patients. About Tenosynovial Giant Cell Tumour (TGCT)Tenosynovial Giant Cell Tumour (TGCT), previously termed pigmented villonodular synovitis (PVNS), is a type of tumour that affects the soft tissue lining of joints and tendons. TGCTs are categorised as fibrohistiocytic tumours by the WHO classification and are subclassified based on growth patterns (localised and diffuse types) and location (tendon sheath, intra- and extra-articular forms). TGCTs are locally destructive and can be aggressive. The disease causes significant joint pain, stiffness, loss of function and reduced quality of life. While most patients undergo surgery, more than 50% of those with diffuse TGCT experience tumour recurrence within three years. If left untreated, TGCT can cause joint deformity, degenerative changes, and even lead to arthrodesis or amputation in severe cases. About CSF-1 and EmactuzumabCSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor (CSF-1R), expressed on macrophages and other immune cells. Emactuzumab is a humanised IgG1 monoclonal antibody targeting CSF-1R, designed to inhibit and deplete macrophages in tumour tissue. Originally developed by Roche, emactuzumab has shown substantial efficacy in clinical studies in TGCT, including an objective response rate of ~71%, rapid tumour reduction, functional improvement, and good tolerability with a manageable safety profile. Emactuzumab may also have utility in other macrophage-driven diseases, and SynOx is actively exploring further development opportunities in these areas. Additional details regarding the ongoing registrational Phase 3 TANGENT study can be found on ClinicalTrials.gov (Identifier: NCT05417789). About SynOx TherapeuticsSynOx Therapeutics Limited is a Dublin and Oxford-based, late-stage clinical biopharmaceutical company developing emactuzumab, a best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, Gilde Healthcare, HealthCap, Bioqube Ventures and Medicxi. Contacts: SynOx Therapeutics Ray Barlow Chief Executive Officer Tel: +44 (0) 208 058 5619 Email: enquiries@synoxtherapeutics.com Vida Strategic Partners (on behalf of SynOx) Tim Brons (Media) 415-675-7402 tbrons@vidasp.com

Fast TrackPhase 3Orphan Drug

01 Apr 2025

·www.globenewswire.com

SynOx Therapeutics Announces Board Chair Transition to Align with Advancing Regulatory and Commercialization Strategy

Newly Appointed Board Chair, Philip Astley-Sparke, Brings Transatlantic Late-Stage Development, Regulatory and Commercial Expertise Strengthened Leadership and Expanded U.S. Presence Positions SynOx for Regulatory Filings and Commercialization of Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT) DUBLIN, Ireland and OXFORD, United Kingdom, April 01, 2025 (GLOBE NEWSWIRE) -- SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced the execution of a planned and orderly transition of its board chair position. Philip Astley-Sparke has been appointed as new chair of the board of directors, reflecting SynOx’s ongoing evolution into a global, commercially focused biotechnology company. Mr. Astley-Sparke succeeds Ton Logtenberg, who has served as board chair since 2021, overseeing the company’s growth into a well-funded, late-stage clinical company. With its Phase 3 registrational trial of emactuzumab in TGCT underway, SynOx has evolved its strategic focus to prioritize global regulatory filings, commercial readiness and increasing its transatlantic footprint. This builds upon recent corporate milestones including the raising of a $92 million Series B round of funding and the ongoing build-out of its US executive leadership team. “Ton has been a steady and invaluable partner through a critical period of growth and maturation for SynOx and we are deeply indebted to him for his leadership over the past several years,” said Ray Barlow, Chief Executive Officer of SynOx Therapeutics. “As we embark on our next phase focused on regulatory and commercial activities, we are happy to welcome Philip as our new board chair. His proven experience leading late-stage, transatlantic companies and guiding assets through regulatory approval and launch preparedness will be pivotal as we prepare for the potential commercialization of emactuzumab.” Mr. Astley-Sparke is a seasoned biotechnology executive with a distinguished track record in building and leading innovative companies across immuno-oncology and rare diseases. With over two decades of experience, he has successfully guided multiple organizations from early-stage through to BLA filing with the United States Food and Drug Administration (FDA) and accompanying commercial launch preparations. He has raised over $1.5 billion in capital and held key leadership roles at Replimune Group Inc, where he currently serves as Executive Chairman, uniQure N.V, and BioVex Group Inc. Notably, at BioVex he played a central role in the development of the first FDA-approved oncolytic virus and oversaw a $1 billion acquisition by Amgen. Mr. Astley-Sparke provides SynOx deep expertise in transatlantic biotech operations, in-house manufacturing scale-up, execution of initial public offerings (IPOs), and strategic growth. About Tenosynovial Giant Cell Tumour (TGCT) Tenosynovial Giant Cell Tumour (TGCT), previously termed pigmented villonodular synovitis (PVNS), is a type of tumour that affects the soft tissue lining of joints and tendons. TGCTs are categorised as fibrohistiocytic tumours by the WHO classification and are subclassified based on growth patterns (localised and diffuse types) and location (tendon sheath, intra- and extra-articular forms). TGCTs are locally destructive and can be aggressive. The disease causes significant joint pain, stiffness, loss of function and reduced quality of life. While most patients undergo surgery, more than 50% of those with diffuse TGCT experience tumour recurrence within three years. If left untreated, TGCT can cause joint deformity, degenerative changes, and even lead to arthrodesis or amputation in severe cases. About CSF-1 and Emactuzumab CSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor (CSF-1R), expressed on macrophages and other immune cells. Emactuzumab is a humanised IgG1 monoclonal antibody targeting CSF-1R, designed to inhibit and deplete macrophages in tumour tissue. Originally developed by Roche, emactuzumab has shown substantial efficacy in clinical studies in TGCT, including an objective response rate of ~71%, rapid tumour reduction, functional improvement, and good tolerability with a manageable safety profile. Emactuzumab may also have utility in other macrophage-driven diseases, and SynOx is actively exploring further development opportunities in these areas. SynOx recently announced the initiation of the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. Additional study details can be found on ClinicalTrials.gov (Identifier: NCT05417789). About SynOx TherapeuticsSynOx Therapeutics Limited is a Dublin and Oxford-based, late-stage clinical biopharmaceutical company developing emactuzumab, a best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, HealthCap, Bioqube Ventures, Medicxi, and Gilde Healthcare. Contacts: SynOx Therapeutics Ray Barlow Chief Executive Officer Tel: +44 (0) 208 058 5619 Email: enquiries@synoxtherapeutics.com Vida Strategic Partners (on behalf of SynOx) Tim Brons (Media) 415-675-7402 tbrons@vidasp.com

Executive ChangePhase 3IPO

100 Deals associated with Emactuzumab

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KEGG	Wiki	ATC	Drug Bank
D11234	Emactuzumab	-	DB14905

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Giant Cell Tumor of Tendon Sheath	Phase 3	Netherlands	Synox Therapeutics Ltd.	28 Jun 2022
Non-Hodgkin's lymphoma refractory	Phase 1	United States	Hoffmann-La Roche, Inc.	14 Mar 2018
Locally Advanced Malignant Solid Neoplasm	Phase 1	United States	Hoffmann-La Roche, Inc.	19 Jan 2015
Locally Advanced Malignant Solid Neoplasm	Phase 1	Belgium	Hoffmann-La Roche, Inc.	19 Jan 2015
Locally Advanced Malignant Solid Neoplasm	Phase 1	France	Hoffmann-La Roche, Inc.	19 Jan 2015
Locally Advanced Malignant Solid Neoplasm	Phase 1	Spain	Hoffmann-La Roche, Inc.	19 Jan 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02323191 (Pubmed \| J Immunother Cancer)	Phase 1	Advanced Malignant Solid Neoplasm	221	Emactuzumab + Atezolizumab	bdazsnuxlx(rijstjeyqe) = Grade ≥3 treatment-related adverse events occurred in 25 (11.3%) patients of which fatigue and rash were the most common (14 patients (6.3%) each) jwyimjquhn (nyydstiulr )	Positive	01 May 2022
NCT01494688 (Pubmed \| Eur J Cancer Care (Engl) \| Eur J Cancer) Manual	Phase 1	Pigmented Villonodular Synovitis	63	Emactuzumab	oekcczpwnf(yqbcsiaguf) = pruritus, asthenia and oedema eozotbljdq (hhwblbnjiy )	Positive	01 Dec 2020
NCT01494688 (Pubmed \| Ann Oncol) Manual	Phase 1	Solid tumor	99	paclitaxel+emactuzumab	gpcozgwygk(upffdnxnrm) = No maximum tolerated dose was reached in either study arm bjebgxpfmf (gruuksbusm )	Negative	01 Aug 2019
NCT01494688 (Pubmed \| Ann Oncol) Manual	Phase 1	Solid tumor	99	emactuzumab		Negative	01 Aug 2019
NCT01494688 (Pubmed \| Lancet Oncol) Manual	Phase 1	Giant Cell Tumors	25	emactuzumab	ssayffahgf(bsvfuvnwbt) = 5 events in 5 pts [lupus erythematosus（2 pts）, periorbital oedema（1 pt）, erythema（1 pt）, dermohypodermitis（1 pt）] wahdtbskdc (mfsgclfkla ) View more	Positive	01 Aug 2015

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