• Financing co-led by Forbion, HealthCap and new investor Bioqube Ventures
  • Funds will be used for pivotal trial of potential best-in-class, next-generation treatment for Tenosynovial Giant Cell Tumour

 Dublin, Ireland and Oxford, UK, 22 April 2024: SynOx Therapeutics Limited (“SynOx” or the “Company”), the late-stage clinical biopharmaceutical company, is pleased to announce the close of a $75m Series B financing. The financing was co-led by Forbion, HealthCap and new investor Bioqube Ventures.

The proceeds will be used to generate registrational Phase 3 clinical and CMC data for emactuzumab, SynOx’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of Tenosynovial Giant Cell Tumour (TGCT).

TGCT is a type of tumour that affects the soft tissue lining of joints and tendons and is a highly debilitating disease often impacting large, important joints such as the knee, hip and ankle.

TGCT is a chronic disease which often impacts patients throughout their lives.  It seriously impacts quality of life by causing significant loss of function of the affected joints, pain, stiffness, and limiting range of motion. While most patients receive surgical intervention, more than 50% of patients with diffuse disease experience tumour recurrence within three years of surgery1..

Emactuzumab is a novel, next-generation CSF-1R mAb with a potentially best-in-class profile.  In earlier clinical work in TGCT2. emactuzumab demonstrated substantial clinical activity with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, and significant improvements in functional ability. Importantly, these studies also indicated that emactuzumab has good tolerability and a manageable safety profile. SynOx is initiating a Phase 3 trial (TANGENT) to assess the efficacy and safety of emactuzumab in patients with localized and diffuse TGCT.

As part of the Series B financing both Dr Carlo Incerti, M.D., and Jon Edwards, PhD, have joined the Board of Directors. Dr Incerti has more than three decades of experience in the biopharmaceutical industry and brings an extensive track record in global drug development, including from his time at Sanofi Genzyme where he played a leading role in pioneering therapies for rare and genetic diseases. Jon Edwards brings a decade of therapeutic investment expertise and company creation experience, which includes several public listings and multi-billion-dollar acquisitions.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: “This is a transformational time for SynOx. This substantial funding will allow us to generate registrational data for emactuzumab in TGCT. As a highly effective, next-generation therapy with a short treatment cycle, rapid onset and long duration of response, we believe that emactuzumab is differentiated from other agents in development and will provide a much needed and valuable option for patients suffering from this grievous disease.”

Dirk Kersten, General Partner at Forbion, commented: “We are pleased to continue to support the SynOx team as it moves emactuzumab through to BLA and MAA submissions in TGCT. As a late-stage company with a clinically de-risked asset, focused on an attractive and underserved market, SynOx is a good example of the type of company Forbion Growth would typically invest in.”

Jon Edwards, Bioqube Ventures commented: We are excited to join the SynOx syndicate and work with this fantastic team and board. We believe this asset has the potential to generate best-in-class data and are excited to help the team develop the product through approval and launch.

Ton Logtenberg, Non-Executive Chair of SynOx Therapeutics, added: “The support of our existing and new investors is validation of SynOx’s strategy and its great potential as a company. I would like to welcome Carlo Incerti and Jon Edwards to the Board of Directors. Their broad experience and knowledge, particularly in driving forward cutting-edge therapies for rare diseases, and executing deals at the highest level, complement the expertise of our existing directors and will be instrumental as we accelerate the late-stage clinical development of emactuzumab.”

For the full press release, please see SynOx Series B Press Release.

References

  1. Lin F, et. al. JHEOR, 2022.
  2. Cassier et al. “Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour” European Journal of Cancer 141:162-170, 2020
  • Axel Mescheder, CMO, to present an update on phase III, registrational trial of emactuzumab for patients suffering with TGCT (TANGENT)
  • Professor David Kerr, FRCP, to present on “Emactuzumab: Target Mediated Drug Disposition”
  • CTOS virtual Annual Meeting 10-13 November 2021

Dublin, Ireland, November 12, 2021: 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 that Dr. Axel Mescheder, CMO, will be presenting plans for TANGENT at the upcoming CTOS Annual Meeting. TANGENT is a phase III multi-centre, randomized, double-blind, group comparator trial to assess the safety and efficacy of emactuzumab vs placebo in patients with TGCT. The Annual Meeting will be held virtually on 10 – 13 November 2021.

TANGENT study design is currently under review with the competent authorities.

In addition, SynOx clinical advisor, Professor David Kerr of Oxford University will also present  on the  pharmacokinetic and pharmacodynamic data generated with emactuzumab in the determination of the biologically optimal dose of emactuzumab in patients.

Axel Mescheder, Chief Medical Officer of SynOx, said: We look forward to sharing an update on the preparation of our Phase III pivotal development program TANGENT with the CTOS attendees. At SynOx we are excited to be moving towards the launch of this this clinical trial in the near future. In addition, Professor David Kerr will share further insight on the pharmacokinetic and pharmacodynamic results of the exploratory clinical trials investigating emactuzumab in TGCT patients.”

 

  • Plans to initiate a pivotal trial for patients suffering from Tenosynovial Giant Cell Tumours (TGCT)
  • Follows €37 M Series A investment to progress emactuzumab, a potentially best-in-class CSF-1R antibody licensed on an exclusive, worldwide basis from Roche

Dublin, Ireland, July 27, 2021: 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 appointment of a new Chairman and Chief Executive Officer and plans for a registrational trial of emactuzumab in the USA and EU.

Professor Ton Logtenberg has been appointed non-executive Chairman. Ton has over 25 years’ experience in the biopharmaceutical industry, including as Co-Founder and Chief Scientific Officer of Crucell N.V. (acquired by Johnson & Johnson for $2.4 billion) and Founder, President and CEO of Merus N.V (NASDAQ: MRUS).

Ton Logtenberg, Chairman of SynOx, said: I am delighted to be joining SynOx as non-executive Chairman.  SynOx’s mission is to focus on the unmet clinical needs of patients with TGCT, a group of rare tumours that form in the joints and is often a progressive disease that negatively impacts young adults in the prime of their life. SynOx is well funded and backed by world leading investors to enable the development of emactuzumab, a late-stage clinical asset with the potential to provide a safe and efficacious treatment for this debilitating disease.” 

Ray Barlow joins SynOx as CEO from Kiadis Pharma N.V. where he was Chief Business Officer up to the successful conclusion of its sale to Sanofi in April 2021.  Ray has over 20 years’ experience in the biopharmaceutical industry gained through leadership positions in scientific, clinical, commercial, and executive roles in global pharmaceutical companies (AstraZeneca, J&J and Amgen), publicly listed biotech companies (Emergent BioSolutions Inc, Crucell N.V., e-Therapeutics PLC and Kiadis Pharma N.V.) and a number of private biotech companies.

Ray Barlow, Chief Executive Officer of SynOx, commented: “I am excited to be joining SynOx as CEO at this critical point in the Company’s journey to establish emactuzumab as a potentially best-in-class treatment for patients with TGCT on a global basis.  Emactuzumab, an IgG1 CSF-1R targeted antibody, has already generated highly promising results as a monotherapy in over 60 patients with TGCT and we look forward to continuing to work with the regulatory agencies to enable the initiation of our upcoming registrational clinical trial (TANGENT) in the USA and EU.”

Jacob Gunterberg, Partner at HealthCap, noted: “We are delighted to welcome Ton and Ray to the SynOx Therapeutics Board and leadership team. We are confident that they will bring significant energy and experience to our mission to establish emactuzumab as the therapeutic treatment of choice for patients with TGCT. We would like to thank Nick La Thangue for his contributions as CEO in the period before the transition to the new leadership.”

Francesco De Rubertis, Partner at Medicxi, added: “We remain excited by the potential of emactuzumab as a best-in-class treatment for TGCT and are pleased to have Ton and Ray join the Company as we continue the development of the asset through confirmatory clinical trials.”

ENDS

For more information please contact:

Optimum Strategic Communications

Mary Clark, Stella Lempidaki, Vici Rabbetts

Tel: +44 (0) 208 078 4357

Email: [email protected]

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.

https://www.ejcancer.com/article/S0959-8049(20)31046-7/abstract

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

 

  • HealthCap and Medicxi co-lead, joined by Forbion and Gimv
  • Financing to develop emactuzumab to improve the lives of patients with tenosynovial giant cell tumours

Dublin, Ireland, November 19, 2020 –SynOx Therapeutics Ltd (“SynOx”), a clinical stage biopharmaceutical company, announces today the closing of a €37 million Series A financing co-led by HealthCap and Medicxi and joined by investors Forbion and Gimv.  

SynOx, a spin out of Celleron Therapeutics Ltd (“Celleron”), secured exclusive world-wide rights for the clinical development, manufacturing and commercialization of emactuzumab under a licence agreement with Roche.The financing will enable SynOx to continue the development of emactuzumab, for the treatment of diffuse tenosynovial giant cell tumours (“TGCT”), also known as pigmented villonodular synovitis (”PVNS”), and other indications.

Emactuzumab is a clinical-stage humanised IgG1 CSF-1R targeted antibody designed to target and deplete macrophages in the tumour tissue. It has shown a favourable safety profile in patients and encouraging efficacy for TGCT, a rare disease characterised by the proliferation of macrophages in the synovial tissue in the joint and tendon sheath.

Professor Nick La Thangue, Chief Executive Officer of SynOx, commented: “We are very excited to be developing emactuzumab as a breakthrough treatment for the extreme and debilitating effects of TGCT.  SynOx will be focused on generating all necessary data to register this new therapy in a time- and cost-efficient way.”

Jacob Gunterberg, Partner at HealthCap, said: “With the objective to develop a new therapy for TGCT patients who suffer from a significantly reduced quality of life, the involvement in the establishment and investment in SynOx fits very well with our investment strategy.”

Francesco De Rubertis, Partner at Medicxi, commented: “We are excited to support SynOx in its continued development of emactuzumab, an agent which has demonstrated profound efficacy in over 60 TGCT patients treated to date.”

The SynOx Board will consist of Jacob Gunterberg (HealthCap), Francesco De Rubertis (Medicxi), Dirk Kersten (Forbion), Michaël Vlemmix (Gimv), Declan Doogan (chairman of Celleron) and Nick La Thangue.

For more information please contact:

Optimum Strategic Communications
Mary Clark, Shabnam Bashir, Manel Mateus
+44 (0) 20 3922 1906
[email protected]

About SynOx Therapeutics

SynOx is a clinical stage biopharmaceutical company. It is a spin out from Celleron Therapeutics Ltd, an oncology company focused on the clinical development of new and innovative therapies to treat cancer. SynOx is developing  emactuzumab, a best-in-class CSF1R targeted therapeutic antibody designed to target and deplete tumour-associated macrophages in the tumour tissue.  SynOx is led by a team of experts that combines biotech and pharma experience with a successful track record of developing and bringing products to market. It is backed by a strong investor syndicate – HealthCap, Medicxi, Forbion and Gimv.

Please visit us at: https://synoxtherapeutics.com/ and on Twitter: @SynOx_Tx

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 https://www.ejcancer.com/article/S0959-8049(20)31046-7/abstract

About Celleron Therapeutics

Celleron is an oncology company focussed on the clinical development of new and innovative therapies to treat cancer. Celleron is developing a novel group of clinical products, supported by predictive companion diagnostics, that act through defined molecular mechanisms to prevent cancer cell growth. The company’s lead products are in clinical trials, supported by a biomarker platform that allows responsive patients to be identified. The company has deep relationships with Oxford University and is located on the Oxford Science Park, United Kingdom. Please visit us at: https://cellerontherapeutics.com

Investor Syndicate Details:

About HealthCap

HealthCap is one of the largest specialized providers of venture capital within life sciences in Europe. Since the start in 1996, HealthCap has backed and built more than 100 companies. HealthCap’s investment strategy focuses on diseases with high unmet medical needs and breakthrough therapies which have the potential to be transformative and improve the lives of patients suffering from these conditions. Please see: www.healthcap.eu and on Twitter: @HealthCapVC

About Medicxi

Medicxi is a European venture capital firm with the mission to create and invest in companies along the full drug development continuum. Medicxi was established by the former Index Ventures life sciences team, which has been active for over 20 years, and invests in both early and late-stage assets with a product vision that can fulfil a clear unmet medical need. GSK, Johnson & Johnson Innovation – JJDC, Inc., Novartis and Verily (an Alphabet company) have invested in Medicxi funds.

For more information, please visit us at www.medicxi.com and follow us on Twitter: @medicxi

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion manages well over EUR 1.25 billion across multiple fund strategies that cover all stages of (bio)pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 69 companies. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fund Investment”. For more information, please visit: www.forbion.com

About Gimv

Gimv is a European investment company, listed on Euronext Brussels, with 40 years’ experience in private equity and venture capital. The company currently has a portfolio of EUR 1.2 billion of investments in around 50 portfolio companies, with combined turnover of EUR 2.5 billion and 14,000 employees. As a recognized market leader in selected investment platforms, Gimv identifies entrepreneurial, innovative companies with high growth potential and supports them in their transformation into market leaders. Gimv’s four investment platforms are Connected Consumer, Health & Care, Smart Industries and Sustainable Cities. Further information on Gimv can be found on: www.gimv.com

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 (CSF-1R) monoclonal antibody and were followed up for up to 2 years after the start of treatment.

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