Emactuzumab
- Generic Name
- Emactuzumab
- Drug Type
- Biotech
- CAS Number
- 1448221-67-7
- Unique Ingredient Identifier
- 6FY6EI1X8R
- Background
Emactuzumab is under investigation in clinical trial NCT01494688 (A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors).
FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor Treatment, Showing 40% Response Rate
• The FDA has granted approval to vimseltinib (DCC-3014) for treating symptomatic tenosynovial giant cell tumor (TGCT), based on positive Phase 3 MOTION trial results.
• The pivotal MOTION study demonstrated a significant 40% objective response rate for vimseltinib compared to 0% for placebo, with notable improvements in patient mobility and pain.
• The twice-weekly oral medication showed a manageable safety profile, with mostly grade 1-2 adverse events, providing a new therapeutic option for TGCT patients.
Advancements in Tenosynovial Giant Cell Tumors Clinical Trials Highlighted for 2024
The Tenosynovial Giant Cell Tumors (TGCT) clinical trials landscape for 2024 showcases significant progress, with over 5 key companies developing more than 5 treatment therapies. Notable developments include the FDA's priority review for vimseltinib, a CSF1R inhibitor, and the EMA's acceptance of its Marketing Authorization Application, signaling a promising future for TGCT treatment.
Pimicotinib Achieves Primary Endpoint in Phase 3 Trial for Tenosynovial Giant Cell Tumor
• Merck KGaA's pimicotinib demonstrated a significant objective response rate (ORR) of 54% at week 25 compared to 3.2% for placebo in the MANEUVER trial.
• The CSF-1R inhibitor showed efficacy in reducing joint stiffness and pain, as measured by NRS and BPI pain scores, respectively.
• Pimicotinib is poised to compete with existing TGCT therapies, including Daiichi Sankyo's Turalio and Ono Pharma's vimseltinib.
• Abbisko Therapeutics will collaborate with Merck on the registration of pimicotinib as a systemic therapy for TGCT in China.
Pharma Update: FDA Eases CGT Path, Tharimmune Surges on EMA Feedback, Lexeo Dips on Alzheimer's Data
• The FDA is creating a more accessible regulatory environment for cell and gene therapy companies, according to executives at BioFuture 2024.
• Tharimmune's stock soared following positive feedback from the EMA regarding its phase II study of TH-104 for pruritus associated with primary biliary cholangitis (PBC).
• Lexeo Therapeutics experienced a stock dip despite releasing positive interim results from its phase I/II study of LX-1001 for APOE4-associated Alzheimer’s disease.
• Biogen and Neomorph have entered into a partnership worth up to $1.45 billion to develop molecular glue degraders for neurological and immunological diseases.
SynOx Therapeutics Raises $92 Million and Doses First Patients in Phase 3 TGCT Trial
• SynOx Therapeutics secured an additional investment in its Series B financing, bringing the total to $92 million to support the Phase 3 TANGENT trial.
• The TANGENT trial is evaluating emactuzumab, a CSF-1R inhibiting monoclonal antibody, for the treatment of Tenosynovial Giant Cell Tumour (TGCT).
• The global, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial has dosed its first patients and aims to enroll approximately 130 participants.
• Emactuzumab has shown promising results in earlier clinical studies, demonstrating substantial tumor response and good tolerability in TGCT patients.
SynOx Therapeutics Raises $92 Million and Doses First Patients in Phase 3 TGCT Trial
• SynOx Therapeutics secured $92 million in Series B funding to advance the Phase 3 TANGENT trial of emactuzumab for Tenosynovial Giant Cell Tumour (TGCT).
• The TANGENT trial is a global, randomized, double-blind, placebo-controlled study evaluating emactuzumab's efficacy and safety in TGCT patients.
• Emactuzumab, a CSF-1R inhibiting monoclonal antibody, has shown promising results in earlier trials, demonstrating a high overall response rate and good tolerability.
• The first patients have been dosed in the TANGENT trial, marking a significant milestone in the development of a potential new treatment option for TGCT.
Tenosynovial Giant Cell Tumors Treatment Market to See Significant Growth by 2034
The Tenosynovial Giant Cell Tumors (TSGCTs) treatment market, valued at approximately USD 300 million in 2023, is expected to grow significantly by 2034. This growth is driven by the increasing prevalence of TSGCTs, advancements in treatment options, and the introduction of novel therapies. Key developments include SynOx Therapeutics securing USD 75 million in Series B funding for the development of emactuzumab, a promising treatment for TSGCTs.
Drug Development Updates
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