Complement Therapeutics secures Innovate UK EDGE funding to collaborate with the Cell and Gene Therapy Catapult on regulatory strategy for CTx001

  • The Innovate UK EDGE grant funding is awarded to innovative companies looking to benefit from the expertise provided by Catapults or Research & Technology Organisations
  • This grant funding further recognises the innovative nature of CTx001, a gene therapy being developed for the treatment of Geographic Atrophy.

London England – 17th November 2022 – Complement Therapeutics Ltd (CTx), a biotechnology company developing novel therapeutics for complement-related diseases, today announced a collaboration with the Cell and Gene Therapy (CGT) Catapult enabled by an Innovate UK EDGE grant funding award. This award allows CTx to benefit from the expertise within CGT Catapult’s Regulatory Affairs and Non-clinical Safety team to evaluate the Company’s non-clinical, chemistry manufacturing and control (CMC), quality and clinical development plans and define a tailored regulatory strategy for its lead product CTx001.

Dr. Rafiq Hasan, CEO at Complement Therapeutics commented: “We are delighted to receive the award from IUK for CTx001, highlighting the innovative potential of this gene therapy for the treatment of GA, a condition with significant unmet need.  We look forward to continuing our collaboration with CGT Catapult, who have been an extended team to us since the formation of the Company, and we plan to strengthen our regulatory strategy through their deep understanding of the global regulatory landscape. CTx aims to maintain a constant dialogue with the regulators to ensure our lead candidate CTx001 reaches the clinic with a robust and validated development plan.’’

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

About Cell and Gene Therapy Catapult:

The Cell and Gene Therapy Catapult is part of the Catapult Network. It was established by, and works in partnership with, Innovate UK.

The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. For more information, please visit https:ct.catapult.org.uk or visit https://www.gov.uk/government/organisations/innovate-uk.

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For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com

MHRA awards Complement Therapeutics Innovation Passport for CTx001 to accelerate Gene Therapy for Geographic Atrophy

  • MHRA granted Complement Therapeutics an Innovation Passport under the new accelerated Innovative Licensing and Access Pathway (ILAP)
  • ILAP is designed to optimise the development and expedite the evaluation of innovative medicines for patients with high unmet need
  • CTx001 is being evaluated as a potential AAV gene therapy for the treatment of visual impairment due to geographic atrophy

London England – 1st November 2022 – Complement Therapeutics Ltd (CTx), a biotechnology company developing novel therapeutics for complement-related diseases, today announced its lead asset CTx001, an AAV-based gene therapy for the treatment of Geographic Atrophy (GA), has been awarded an Innovation Passport by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

CTx001 was awarded the Innovation Passport based on three criteria: that the condition addressed is seriously debilitating with a significant patient need; an advanced therapy medicinal product classified as innovative; and that the medicine has the potential to offer transformative benefits to patients.

“Receiving the Innovation Passport Designation is a key regulatory accomplishment and has the potential to help GA patients in the UK gain faster access to our novel gene therapy,” said Dr Rafiq Hasan, CEO of Complement Therapeutics. “It provides recognition from the MHRA of the unique mechanism of action of CTx001, with the potential to change the treatment landscape for GA patients. We look forward to working with the MHRA and other agencies to advance the CTx001 development programme.”

The Innovation Passport is the first step in the Innovative Licensing and Access Pathway (ILAP) by providing opportunities for enhanced regulatory support from the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and National Health Service (NHS) England. CTx will work with these agencies on a Target Development Profile (TDP) for CTx001, that will set out a roadmap for regulatory and development milestones to enable early patient access in the UK. Other benefits of ILAP, include the potential for a 150-day accelerated Marketing Authorisation Application (MAA) assessment, a rolling review and a continuous risk-benefit assessment.

About ILAP:

The MHRA launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. It provides a single integrated platform for collaboration between the developer of the investigational medicine, the MHRA and its partners. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders.

More background on the ILAP can be found at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

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For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com

Complement Therapeutics Announces the Establishment of its Clinical & Scientific Advisory Board

London, England – 27th September 2022 – Complement Therapeutics Ltd (CTx), a preclinical stage biotechnology company, today announced the formation of its inaugural Clinical & Scientific Advisory Board which will accelerate the development of the company’s novel therapeutic pipeline including its lead investigational product CTx001, a gene therapy for dry age-related macular degeneration/geographic atrophy. Our distinguished advisory board members come with a breadth of extensive experience and expertise in ophthalmology and the complement system and will work closely with CTx management and scientific teams to advance our pipeline of products targeting complement-related diseases.

“The creation of this expert advisory board with renowned international specialists will provide CTx with invaluable counsel across a range of topics including complement biology, ophthalmology, preclinical and clinical development. We are honoured that such esteemed experts have agreed to join our team to support the company as we continue to build our momentum and ensure we enter the clinic with the strongest possible development plan.” said Dr Rafiq Hasan, CEO of Complement Therapeutics.

Clinical & Scientific Advisory Board Members:

Robyn Guymer, Ph.D. Professor Robyn Guymer is the Deputy Director and Head of Macular Research at Centre for Eye Research Australia, leading a team that is primarily investigating AMD, and has authored over 300 peer-reviewed papers. In addition to also being a Professor of Ophthalmology at Melbourne University and a senior retinal specialist at the Royal Victorian Eye and Ear Hospital, she was named a Member in the General Division (AM) in the 2018 Queen’s Birthday Honours List for her significant service in ophthalmology, particularly AMD. Professor Guymer also sits on several pharmaceutical advisory boards including the Beckman/Ryan AMD initiative and the International Classification of Atrophy (CAM) group.

Jeff Heier, MD. Dr. Jeffrey S. Heier is the Director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston (OCB), one of the most prestigious ophthalmologic practices in the United States. He is the President of the Retina Society, on the Executive Committee of the American Society of Retina Specialists, Past President of the New England Ophthalmological Society, and a member of the Macula Society.  Dr. Heier serves or has served as the Study Chairman or Lead Principal Investigator of numerous clinical trials.  Dr. Heier has received the Secretariat and Lifetime Achievement Award from the AAO and Senior Achievement Award from the ASRS. He has authored or co-authored more than 150 works in peer-reviewed journals and has served as a reviewer for journals including the Lancet, Retina, Ophthalmology and New England Journal of Medicine.

Peter Kaiser, MD. Dr Peter K. Kaiser, M.D., is the director of Center for Ocular Research and Evaluation (CORE) and a RO1-funded prinicipal investigator at the National Institute of Health. He is actively involved in clincial research having served as Study Chairman for over 60 trials evaluating new treatments for AMD, DR, and other retinal disorders. Dr. Kaiser has been honored to receive the Lew R. Wasserman Award from the Research to Prevent Blindness and the Macula Society’s Young Investigator Award. Complementing his research endeavors, Dr. Kaiser serves on numerous scientific advisory boards and addresses his research interests as an invited speaker at national and international conferences. Dr. Kaiser has authored 7 textbooks, 30 book chapters, and more than 400 peer-reviewed papers, and is Editor-in-Chief of Retinal Physician, Associate Editor of International Ophthalmology Clinics, and serves on other editorial boards. Dr. Kaiser has been recognized by American Society of Retina Specialists Honor and Senior Honor Awards, along with the American Academy of Ophthalmology Achievement, Senior Achievement, and Lifetime Achievement Awards. He has been listed as one of the “Best Doctors in America” every year since 2002 and has appeared on the Ophthalmologist’s “Power List” in 2016, 2018 and 2020 as one of the top 100 most influential people in the world of ophthalmology.

Paul Morgan, Ph.D. Professor Paul Morgan brings over 30 years’ worth of experience in the complement system and is currently based in Cardiff University in the Division of Infection and Immunity. Professor Morgan has published over 300 research papers and is a research specialist in Clinical Immunology, and is a Member of the College of Physicians, Fellow of the College of Pathologists and Fellow of the Academy of Medical Sciences. Professor Morgan has been President of the International Complement Society (2011-2014), was elected Fellowship of Academia Europaea in 2015, and is the Group Leader at the UK Dementia Research Institute in Cardiff.

Matthew Pickering, Ph.D. Matthew Pickering is Professor of Rheumatology and Wellcome Trust Senior Fellow in Clinical Science at the Centre for Inflammatory Disease, Department of Immunology and Inflammation, Imperial College London. He is an established international expert on the complement system and its role in health and disease. His clinical expertise includes systemic lupus erythematous and complement deficiency states. His research has achieved international recognition for elucidating the relationship between uncontrolled complement activation and kidney disease. His research program uses genetic characterization of families with complement-mediated renal disease, in vitro studies of complement regulatory proteins and the generation of unique models of complement-mediated kidney disease. He implemented C3 glomerulopathy as a new disease classification within the international kidney pathology and nephrology community and has elucidated the mechanistic basis underlying many types of C3 glomerulopathy. Prof Pickering joins our advisory board on an independent basis through Imperial Consultants.

Nadia Waheed, MD, MPH Dr. Nadia Waheed was the Chief Medical Officer at Gyroscope Therapeutics and previously the Director of the Boston Image Reading Center.  She also established the Retina Unit at the Shifa Hospital. She is currently a Professor in Ophthalmology and attending physician specialising in vitreoretinal disorders and surgery and ocular imaging at the Tufts University Department of Ophthalmology. Dr. Waheed has authored over 100 papers in peer-reviewed publications, has co-authored and edited three books in Ophthalmology, and has participated as a principal investigator or co-investigator in multiple clinical trials. She has been recognized by both the American Academy of Ophthalmology and the Macula Society with an Achievement Award.

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For more information please contact:

Complement Therapeutics Ltd

Dr Rafiq Hasan, CEO

Email: rafiq@complementtx.com

Notes to Editor

About Complement Therapeutics Ltd

Complement Therapeutics (CTx) is an early stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases as well as developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform.

The Company is backed by Forbion and Biogeneration Ventures, two of Europe’s leading investors and is based on the pioneering research of its founders into novel targets within the complement cascade and its quantification. The CPM platform employs a unique methodology to quantify over 30 complement cascade proteins.

Our lead investigational product (CTx001) is a gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

Complement Therapeutics Ltd announces appointment of Dr Dennis Keefe as Chief Scientific Officer

London, England – 10th August 2022 – Complement Therapeutics Ltd (CTx), a preclinical stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases, announces the appointment of Dr Dennis Keefe as Chief Scientific Officer. Dennis will be responsible for developing and executing the Company’s  overall scientific and research strategy as it advances its innovative pipeline of assets addressing unmet needs in complement mediated diseases such as geographic atrophy due to dry age-related macular degeneration, a major cause of vision loss and blindness globally.

Dennis is an accomplished biopharmaceutical executive with over 15 year’s experience in the sector. He is a skilled drug developer with comprehensive experience across multiple therapeutic platforms including biologics, small molecules, RNA medicines and gene therapy. Dennis was previously CSO of Prothelia where he was responsible for all preclinical and nonclinical development efforts. Prior to this role, Dennis held numerous roles of increasing responsibility at Millenium Pharmaceuticals, Shire Pharmaceuticals and Stealth Biotherapeutics, where he led the preclinical development of the ophthalmology pipeline. In addition to ophthalmology, Dennis brings significant expertise in autoimmune, neurodegenerative and rare disease drug development.

Dr Rafiq Hasan, CEO, Complement Therapeutics Ltd commented, “It is a real pleasure and a privilege to welcome Dennis to the CTx team. His expertise and experience in both complement mediated conditions and ophthalmology will be invaluable to the company as we drive development of our novel pipeline and analytics platform with the potential to have a tremendous impact on the quality of life of those affected with vision loss and blindness.”

Dennis Keefe, Chief Scientific Officer, commented, “I am excited to be joining CTx at this juncture and look forward to working with the growing team to develop a portfolio of innovative treatments and medicines to address the significant unmet need in both ophthalmology and broader complement driven diseases.”

Dennis has a PhD from Tufts University and an MBA from Northeastern University and will be based in Boston, MA.

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For more information please contact:

Complement Therapeutics Ltd

Dr Rafiq Hasan, CEO

Email: rafiq@complementtx.com

Notes to Editor

About Complement Therapeutics Ltd

Complement Therapeutics (CTx) is an early stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases as well as developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform.

The Company is backed by Forbion and Biogeneration Ventures, two of Europe’s leading investors and is based on the pioneering research of its founders into novel targets within the complement cascade and its quantification.

Our lead investigational product (CTx001) is a gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions. The Company is also developing the CPM platform, which employs a unique methodology to quantify over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

Complement Therapeutics Ltd announces appointment of Steve Axon to its Board of Directors

Complement Therapeutics Ltd announces appointment of Steve Axon to its Board of Directors

London, England – 18th July 2022 – Complement Therapeutics Ltd (CTx), a preclinical stage biotechnology company, announced today the appointment of Steve Axon to its Board of Directors. Steve joined the Board in May 2022 as an independent director and will support CTx in addressing unmet needs in complement mediated diseases such as geographic atrophy due to dry age-related macular degeneration, a major cause of vision loss and blindness globally.

Steve is a seasoned biopharmaceutical executive with over 20 years experience in the sector. Steve is currently the CEO of Glycomine, a clinical-stage company focused on developing new therapies for serious unserved orphan diseases. He previously served as CEO of Prothelia, a preclinical company focused on muscular dystrophy, as Chief Business Officer at Apellis Pharmaceuticals (Nasdaq: APLS), a leading global pharmaceutical company focused on complement driven diseases and as Senior Vice President of Business Development at Merck KGaA.

Dr Rafiq Hasan, CEO, Complement Therapeutics Ltd commented, ‘It is a real pleasure and privilege to welcome Steve to our Board. His expertise and experience in both complement mediated conditions and the sector more broadly will be invaluable to the company as we drive forward our novel pipeline and analytics platform’. 

Steve Axon, independent director, commented ‘I am excited to be joining the Board of CTx at such an exciting time and look forward to working with the growing team to develop innovative medicines addressing significant unmet need in both ophthalmology and broader complement driven diseases’. 

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For more information please contact:

Complement Therapeutics Ltd

Dr Rafiq Hasan, CEO

Email: rafiq@complementtx.com

Notes to Editor

About Complement Therapeutics Ltd

Complement Therapeutics (CTx) is an early stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases as well as developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform.

The Company is backed by Forbion and Biogeneration Ventures, two of Europe’s leading investors and is based on the pioneering research of its founders into novel targets within the complement cascade and its quantification. The CPM platform employs a unique methodology to quantify over 30 complement cascade proteins.

Our lead investigational product (CTx001) is a gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

Complement Therapeutics Ltd raises EUR 5 Million Seed Financing by BGV and Forbion and appoints Dr Rafiq Hasan as CEO

  • Next-generation Complement Therapeutics based on the role of Factor H-related proteins in complement-mediated diseases
  • Company emerges out of stealth mode with plans to raise a Series A round in 2022 to fund further preclinical and early clinical development
  • Dr. Rafiq Hasan appointed as CEO with Dr. John Ford as independent director

London, England – 23 February 2022 – Complement Therapeutics Ltd (CTx), a preclinical stage University of Manchester spinout, announced today the completion of its EUR 5 million seed financing round from BioGeneration Ventures (BGV) who provided the initial seed-funding in early 2021 and Forbion, two leading European venture capital firms.

Built on the pioneering research carried out by its three founders at the University of Manchester, Prof Simon J. Clark, Prof Paul Bishop, and Dr Richard Unwin, the CTx team will focus on addressing unmet needs in complement mediated diseases such as geographic atrophy due to dry age-related macular degeneration, a major cause of vision loss and blindness globally. In particular, the founders have conducted highly innovative research into the pathophysiology of complement driven diseases, having recently published work on the role of factor H related (FHR) proteins in age related macular degeneration (AMD; see references). In addition to its pipeline of therapeutic candidates, CTx has developed a precision medicine diagnostic platform allowing it to stratify patients based on their complement-activation profile with the potential to enable both patient selection and serving as an efficacy biomarker in future clinical studies.

The company also announced the appointments of two highly experienced industry executives, Dr Rafiq Hasan as Chief Executive Officer and Dr. John Ford as an independent director.

Dr Hasan has pursued a highly successful career in the pharma industry globally, including senior positions in ophthalmology with Bayer and Novartis. Most recently as SVP and Global Head of Ophthalmology at Bayer, Dr Hasan grew the business of Eylea® from launch to over USD 2.5bn in 5 years, including its launch in 5 indications in 3 years.

Dr Rafiq Hasan, Chief Executive Officer, CTx commented: “I am very excited to be joining CTx to advance innovative therapeutic modalities for the treatment of complement driven diseases such as dry AMD. With the ongoing support from our investors BGV and Forbion, I look forward to establishing the company as a leader in the field.”

Dr John Ford is an experienced biotechnology entrepreneur having co-founded Xention (CSO), Ario Pharma (CEO) and Metrion Biosciences (co-owner). “Having worked with BGV and Forbion for many years, I am confident that we can continue to contribute to the growth of the CTx team.”

Dr Geert-Jan Mulder, Managing Partner at Forbion and CTx Board member commented: “We are pleased to have the opportunity to continue our successful track-record in investing in innovative companies in ophthalmology. Dr Dmitrij Hristodorov, Partner at Forbion and CTx Board member added: “Rafiq and I have been successfully working together at Bayer and I am excited to continue this collaboration with him and his team advancing new science towards products for patients that make a difference. CTx has all the ingredients to become the next-generation complement company for diseases of the eye and beyond.”

Dr Max Klement, Principal at BGV commented: “BGV identified Complement Therapeutics as a promising opportunity in complement biology late 2020. Together with the founders and the team, we developed the plans for the lead indication in ophthalmology and other indications. With this additional financing and support of Forbion, our longstanding joint venture partner, CTx is well positioned to develop novel ground-breaking therapies for patients suffering from complement driven diseases.”

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For more information please contact:

Complement Therapeutics Ltd

Dr Rafiq Hasan, CEO

Email: rafiq@complementtx.com

Forbion and BGV

Laura Asbjornsen

Email: laura.asbjornsen@forbion.com

Consilium Strategic Communication

Ashley Tapp, Sue Charles

Email: forbion@consilium-comms.com

Tel: +44 (0)20 3709 5700

Notes to Editor

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.8 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 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. 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 Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

For more information, please visit: www.forbion.com

About BGV

BioGeneration Ventures (BGV) is a venture capital company, with a focus on early-stage European biotech companies. The Company has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class companies.

BGV manages over EUR 225 million of funds investing in areas where true scientific innovations, the unmet medical need, and the potential to demonstrate a significant proof of concept all come together.

BGV strives to work with founding teams to mature science and build companies. The Company uses its experience to guide progress into clinical trials, ultimately leading to successful drug development and value realization for its investors. BGV applies its expertise in a rigorous process to select the most compelling opportunities with the best prospects for exit.

BGV is based in Naarden, The Netherlands. For more information, please visit:  www.biogenerationventures.com

About Complement Therapeutics Ltd

Complement Therapeutics (CTx) is an early stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases as well as developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform.

The Company is a spin out from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade and its quantification. The CPM platform employs a unique methodology to quantify over 30 complement cascade proteins.

Our lead investigational product (CTx001) is a gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.


References

Cipriani, V. et al. Beyond factor H: The impact of genetic-risk variants for age-related macular degeneration on circulating factor-H-like 1 and factor-H-related protein concentrations. American Journal of Human Genetics (2021).

Lorés-Motta, L. et al. Common haplotypes at the CFH locus and low-frequency variants in CFHR2 and CFHR5 associate with systemic FHR concentrations and age-related macular degeneration. American Journal of Human Genetics (2021).

Cipriani, V. et al. Increased circulating levels of Factor H-Related Protein 4 are strongly associated with age-related macular degeneration. Nature Communications (2020).

Clark, S.J., et al. Bruch’s Membrane Compartmentalizes Complement Regulation in the Eye with Implications for Therapeutic Design in Age-Related Macular Degeneration. Frontiers in Immunology (2017).


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