SynOx Therapeutics has announced the completion of a $92 million Series B financing round and the commencement of its Phase 3 TANGENT trial for emactuzumab in patients with Tenosynovial Giant Cell Tumour (TGCT). The funding will support the registrational Phase 3 clinical trial of emactuzumab, a CSF-1R inhibiting monoclonal antibody.
TANGENT Trial Details
The TANGENT trial is a global, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. Approximately 130 patients are expected to be enrolled. The primary outcome measure is overall response rate (ORR). Secondary outcomes include functional and quality of life measurements, impact on tumor volume, and duration of response. The study is registered on ClinicalTrials.gov (Identifier: NCT05417789).
Emactuzumab: A Potential Best-in-Class Therapy
Emactuzumab is a humanized IgG1 CSF-1R targeted antibody that inhibits and depletes macrophages in the tumor tissue. Previous clinical studies in 63 patients with TGCT showed an overall response rate of approximately 71% with good tolerability. The drug offers a short treatment cycle, rapid onset of action, and long duration of response.
Tenosynovial Giant Cell Tumour (TGCT)
TGCT is a rare, non-malignant but aggressively growing tumor of the synovium, 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, pain, stiffness and limited range of motion. Most patients receive surgical intervention, with three-year post-surgery recurrence rates in more than 50% of patients. If left untreated complications include moderate to severe joint deformity, degenerative articular changes, and osteoarthritis, which if severe enough, can lead to cortical bone destruction and occasionally the need for arthrodesis or amputation.
Executive Perspectives
"We are pleased to add Gilde Healthcare to our impressive investor syndicate and are appreciative for their support of our team and our vision for the potential of emactuzumab to address the unmet needs, and improve the quality of life, of TGCT patients around the world," said Ray Barlow, Ph.D., Chief Executive Officer of SynOx. Arthur Franken, general partner at Gilde Healthcare, added, "We are pleased to join SynOx as an investor and help support the late-stage development of emactuzumab, which we believe has a best-in-class profile as a CSF-1R targeted antibody."
