emactuzumab (RG7155) / Roche, SynOx Therap - LARVOL DELTA

Primary Analysis of TANGENT: A Phase 3 Randomised Trial Evaluating the Safety and Efficacy of Emactuzumab in Patients With Tenosynovial Giant Cell Tumours (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

TANGENT: Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT) (clinicaltrials.gov) - P3 | N=128 | Active, not recruiting | Sponsor: SynOx Therapeutics Limited | Trial completion date: Sep 2027 ➔ Sep 2030

Trial completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

TANGENT study design: a phase III, randomized study of emactuzumab for the treatment of tenosynovial giant cell tumors. (PubMed, Future Oncol) - P3 | "In a phase I study, emactuzumab resulted in robust and durable responses, and a manageable safety profile in patients with TGCT, supporting further research as a treatment option to address unmet need and improve quality of life in patients with TGCT. TANGENT is a randomized, double-blind, global, phase III study (NCT05417789) to investigate the safety and efficacy of intravenous emactuzumab versus placebo in patients with TGCT not amenable to surgery.Clinical trial registration: www.clinicaltrials.gov identifier is NCT05417789 initially registered on 1 June 2022."

Clinical • Journal • P3 data • Giant Cell Tumor of Bone • Oncology • Pain • Tenosynovial Giant Cell Tumor

Effects of colony stimulating-factor 1 receptor inhibitors in an in vitro cell culture model using synovial fluids from tenosynovial giant cell tumor patients (EULAR 2026) - "The remaining cells were cultured in plates with or without exposure to a CSF1R inhibitor (kinase inhibitor (Imatinib, Pexidartinib, Vimseltinib, Pimicotinib) or neutralizing antibody (Emactuzumab)). Analyses on more samples are required to confirm these results and identify predictive factors of response to inhibitors. Image(s), graphic(s), or table(s)"

Preclinical • Giant Cell Tumor of Bone • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Tenosynovial Giant Cell Tumor • CD14 • CD163 • CEACAM8 • MERTK • NCAM1 • PTPRC • THY1

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Phase classification: P4 ➔ P3

Phase classification • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P4 trial • Oncology

SNX-301-020: A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. nPlacebo in Subjects with Tenosynovial Giant Cell Tumour (clinicaltrialsregister.eu) - P2/3 | N=100 | Recruiting | Sponsor: Synox Therapeutics Limited | Active, not recruiting ➔ Recruiting

Enrollment open • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2028 ➔ Jul 2028 | Trial primary completion date: Dec 2028 ➔ Jul 2028

Trial completion date • Trial primary completion date • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology

Pathogenic fibroblasts and macrophages localize in the synovial lining and fluid of Diffuse Tenosynovial Giant Cell Tumor. (EWRR 2026) - "Synovial fluids from D-TGCT reflected some aspects of the tumors such as high concentration of SPP1 compared to other joint diseases (osteoarthritis, rheumatoid arthritis) and abundance of CD163+ macrophages that were sensitive to several CSF1 receptor inhibitors (Imatinib, Pexidartinib, Emactuzumab) in culture. Whether the mutated fibroblasts found in the synovial fluid of D-TGCT patients could participate in disease spread and aggressiveness still remains to be explored. Image 1 Proposed model of D- and L-TGCT"

Giant Cell Tumor of Bone • Immunology • Oncology • Osteoarthritis • Rheumatoid Arthritis • Tenosynovial Giant Cell Tumor • CD163 • CXCL12 • PRG4 • SPP1 • THY1

SynOx Therapeutics Announces Positive Topline Results from the Phase 3 TANGENT Study, Supporting Emactuzumab as a Differentiated, Next-generation Treatment for Patients with Tenosynovial Giant Cell Tumor (TGCT) (GlobeNewswire) - "TANGENT met its primary and secondary endpoints with a high level of statistical significance vs. placebo at 6 months, including ORR by RECIST V1.1 and Tumor Volume Score (TVS), and clinically meaningful improvements in PROMIS-PF and other patient -relevant functional measures. Rapid onset and significant functional improvement observed. Short-course regimen demonstrated sustained and durable clinical benefits, highlighting the potential to avoid chronic treatment burden....Based on these data, SynOx plans to submit a BLA to the U.S. Food and Drug Administration for emactuzumab in TGCT in the second half of 2026 and a MAA in the EU thereafter."

EMA filing • FDA filing • P3 data: top line • Tenosynovial Giant Cell Tumor

Management of tenosynovial giant cell tumor: approved and investigational therapies. (PubMed, Expert Rev Anticancer Ther) - "Pexidartinib and vimseltinib demonstrate comparable efficacy in TGCT with objective response rates (ORR) of 39% and 40%, respectively, at week 25 of treatment; however, vimseltinib offers improved hepatic safety and tolerability, supporting its use as the preferred first-line systemic therapy. Emerging agents, including pimicotinib and emactuzumab, show potential for higher response rates and favorable safety profiles and may further reshape the TGCT treatment paradigm pending phase 3 trial results."

Journal • Review • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

TANGENT: Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT) (clinicaltrials.gov) - P3 | N=128 | Active, not recruiting | Sponsor: SynOx Therapeutics Limited | Trial primary completion date: Apr 2026 ➔ Dec 2025

Trial primary completion date • Giant Cell Tumor of Bone • Tenosynovial Giant Cell Tumor

SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline (GlobeNewswire) - "SynOx Therapeutics Limited...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."

Enrollment closed • P3 data: top line • Tenosynovial Giant Cell Tumor

A phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor (TANGENT). (ASCO 2025) - P3 | "Assessments include tumor evaluation, physical examination, vital signs, electrocardiograms, questionnaires, urinalyses, and blood tests for hematology, biochemistry, and PK of emactuzumab. Safety will be assessed by laboratory assessments and evaluation of adverse events."

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Pain • Tenosynovial Giant Cell Tumor

Medical Management of Tenosynovial Giant Cell Tumor. (PubMed, Curr Oncol Rep) - "For an alternative to surgery, the CSF1R inhibitors pexidartinib and vimseltinib are approved in the United States for TGCT, and other CSF1R inhibitors are in clinical development...The potential risks and benefits of available treatments should be carefully considered in collaboration with a bone tumor-experienced, multidisciplinary team to determine the best course of care. Increased D-TGCT awareness and support through patient advocacy groups have helped to reshape the patient journey."

Journal • Review • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Solid Tumor • Tenosynovial Giant Cell Tumor

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

Fast track • Tenosynovial Giant Cell Tumor

SynOx Therapeutics Announces Board Chair Transition to Align with Advancing Regulatory and Commercialization Strategy (GlobeNewswire) - "Strengthened Leadership and Expanded U.S. Presence Positions SynOx for Regulatory Filings and Commercialization of Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)."

Commercial • Tenosynovial Giant Cell Tumor

TANGENT: A phase III, global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of emactuzumab in patients with tenosynovial giant cell tumor (Sarcoma-RC 2025) - P3 | "The Phase 3 study is enrolling patients. Trial Design Phase 3, global, double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of fixed i.v. infusions of emactuzumab in TGCT patients."

Clinical • P3 data • Giant Cell Tumor of Bone • Musculoskeletal Pain • Oncology • Pain • Tenosynovial Giant Cell Tumor

A PHASE 3 MULTI-CENTER, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF EMACTUZUMAB IN PATIENTS WITH TENOSYNOVIAL GIANT CELL TUMOR TANGENT) (CTOS 2024) - P3 | "There are currently no worldwide approved systemic therapies available for the treatment of patients with TGCT. Emactuzumab demonstrated a favorable risk-benefit profile in early phase clinical studies without the need of chronic and/or daily treatment, which has been recognized to be important for the future treatment of TGCT. The efficacy and safety of emactuzumab in patients with TGCT will be further assessed in the Phase 3 TANGENT trial.References:1."

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

SynOx Therapeutics Further Strengthens Executive Team with Appointments of U.S.-Based Chief Medical Officer and Chief Commercial Officer (GlobeNewswire) - "SynOx Therapeutics Limited...today announced the appointments of Elyse Seltzer, M.D., as Chief Medical Officer (CMO) and Robert Francomano as Chief Commercial Officer (CCO). These strategic hires come at a pivotal time as SynOx accelerates the clinical development of emactuzumab, a potentially best-in-class CSF-1R inhibiting monoclonal antibody...'SynOx expects that his experience will be vital in preparing for the potential commercialization of emactuzumab and expanding the company’s footprint in the global market.'"

Clinical • Tenosynovial Giant Cell Tumor

SynOx Therapeutics Adds New Investor and Capital to Series B Financing, Raising Total to $92 Million, and Doses First Patients in Phase 3 Trial (GlobeNewswire) - "SynOx Therapeutics Limited...announced that it has raised additional funding in a final close of its Series B financing....Proceeds from the financing are supporting a registrational Phase 3 clinical trial of emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody for the treatment of Tenosynovial Giant Cell Tumour (TGCT). In conjunction with the closing of the Series B extension, SynOx today announced that the first patients have been dosed in its Phase 3 registrational study of emactuzumab."

Financing • Trial status • Tenosynovial Giant Cell Tumor

TANGENT: Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT) (clinicaltrials.gov) - P3 | N=128 | Recruiting | Sponsor: SynOx Therapeutics Limited | Trial primary completion date: Sep 2027 ➔ Apr 2026

Trial primary completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

SynOx Therapeutics secures up to $35m debt financing with Hercules Capital to progress development and commercialisation of emactuzumab (PRNewswire) - "SynOx Therapeutics Limited...announces it has entered into a $35m loan facility with Hercules Capital....The transaction strengthens the Company's balance sheet as it executes TANGENT, a registrational Phase 3 study of emactuzumab, SynOx's potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of TGCT. This loan facility provides SynOx with flexibility to fund additional clinical work in TGCT to augment TANGENT, activities to support the successful registration and commercialisation of emactuzumab in TGCT, and potentially to explore the use of emactuzumab in other CSF-1 driven and macrophage-mediated diseases."

Financing • Tenosynovial Giant Cell Tumor