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 News Release - August 3, 2021

SynOx Therapeutics Further Strengthens Team with Appointments of Chief Medical Officer and Chief Technology Officer

Seasoned team to drive forward pivotal trial for patients suffering from Tenosynovial Giant Cell Tumours (TGCT)

Follows recent appointments of Professor Ton Logtenberg as non-executive Chairman and Ray Barlow as Chief Executive Officer

DUBLIN, Aug. 3, 2021 -- (Healthcare Sales & Marketing Network) -- SynOx Therapeutics Limited ("SynOx" or the "Company"), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumours (TGCT), today announces the appointments of Axel Mescheder, MD as Chief Medical Officer and Broes Naeye, PhD as Chief Technology Officer, as it accelerates activities to support a registrational trial of emactuzumab in the USA and EU.

Axel Mescheder, MD, Chief Medical Officer has over 25 years of clinical development and regulatory experience in biotechnology and pharmaceutical companies, including Hoffmann-La Roche and MorphoSys, where he held a range of senior leadership positions. Axel has a strong track record of executing clinical development programs, resulting in successful product registrations and label extensions. His expertise includes oncology, immunology, and inflammation.

Axel Mescheder, MD, Chief Medical Officer of SynOx, commented: "I am privileged to join SynOx at this stage of development. I am impressed by the comprehensive research and compelling early clinical data in the treatment of TCGT. I look forward to supporting the team in the further clinical and regulatory development of emactuzumab to help TCGT patients."

Broes Naeye, PhD, Chief Technology Officer has more than 10 years of experience in development and commercialization of biopharmaceuticals. Most recently, he served as Global Product Supply Lead at Sanofi, where he was responsible for the global supply of Dupixent®. Previously, he was Head of Commercial Supply and CMC Project Lead at Ablynx.

Broes Naeye, PhD, Chief Technology Officer of SynOx, said: "I am excited to be joining SynOx and I am looking forward to developing a robust CMC foundation for emactuzumab as we enter into confirmatory clinical trials and begin preparations for commercialisation."

Ray Barlow, Chief Executive Officer of SynOx, added: "We are delighted to welcome Axel and Broes to the SynOx Senior Management Team. We are confident that their experience of developing biological products through to approval and commercialisation will help drive the continued development of emactuzumab as a potentially best-in-class treatment for patients with TGCT on a global basis."

About SynOx

SynOx Therapeutics Limited is a Dublin, Ireland-based, late-stage clinical biopharmaceutical company developing emactuzumab, a best-in-class monoclonal antibody against CSF-1R, for the treatment of tenosynovial giant cell tumours (TGCT) and other macrophage related disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialisation. It is backed by a strong syndicate of premier life science investors including HealthCap, Medicxi, Forbion and Gimv. Other shareholders include Celleron Therapeutics and Roche.

About Tenosynovial Giant Cell Tumours (TGCT)

Tenosynovial Giant Cell Tumours (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, and intra- and extra-articular forms). TGCTs are locally destructive and aggressive tumours.

TGCT is a rare disease, with a prevalence of 44.3 per 100,000 persons for local-TGCT and 11.5 per 100,000 for diffuse-TGCT (Ehrenstein et al. 2017). While TGCT is not in itself a life-threatening disease, it does result in important functional impairments, significant joint damage, and decline in quality of life, which carries a high healthcare burden and loss of work productivity.

In diffuse TGCT, the tumour is multinodular, infiltrative of soft tissue mass with villous projections, largely composed of immune cells and transformed osteoclast-like cells drawn to the joint by the over-expression of CSF-1. This creates an inflammatory milieu, where diseased tissue diffusely borders healthy tissue, which has implications for the unsatisfactory success rate of surgical excision.

TGCT is clinically characterised by pain, swelling, and range of movement limitations with significant impact on quality of life as a result. It is predominantly a mono-articular disease, typically affecting the lower limbs (knee, hip, ankle), although shoulder, elbow and smaller joints may also be altered. Unique instances of poly-articular disease have been documented.

Symptoms typically progress slowly. If left untreated complications include moderate to severe joint deformity, degenerative articular changes, and osteoarthritis, which if severe enough, have led to cortical bone destruction and occasionally the need for arthrodesis or amputation.

About CSF-1 and Emactuzumab

CSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor, expressed on macrophages and certain other cells, with effects on production, differentiation, and function of these cells.CSF-1R is a tyrosine kinase transmembrane receptor and member of the CSF-1/PDGF receptor family of tyrosine-protein kinases. The CSF-1/CSF-1R pathway is important in regulation of osteoclast proliferation and differentiation, the regulation of bone resorption, and is required for normal bone and tooth development. It is also required for normal male and female fertility, and for normal development of milk ducts and acinar structures in the mammary gland during pregnancy.

In disease, important features include promotion of reorganization of the actin cytoskeleton, formation of membrane ruffles, cell adhesion and cell migration, and thus may promote cancer cell invasion.

Emactuzumab is a clinical-stage, humanised IgG1 CSF-1R targeted antibody designed to target and deplete macrophages in the tumour tissue. Emactuzumab was originally discovered and developed by Roche and has been tested in several phase 1/b studies as a monotherapy and in combination with other agents, including chemotherapeutics and immunotherapies. In clinical studies as a monotherapy in 63 patients with TGCT, emactuzumab has shown a substantial impact on tumour size (ORR of ~71%) and a favourable safety profile.

A paper on emactuzumab was published in the European Journal of Cancer, Volume 141, December 2020 edition, Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour.

Emactuzumab may also have utility in other macrophage driven diseases and the company is actively considering potential options in these areas.

Source: SynOx Therapeutics

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