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Munich, Germany – 9^th May 2024 – The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry; Touchlight, a company pioneering enzymatic DNA production; and Complement Therapeutics, a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announce that they have been awarded over £1 million in a grant from Innovate UK, as part of the ‘Innovative Technologies: Nucleic Acid Medicines Manufacture’ competition.

For potentially life-changing gene therapies to become more widely available to patients, there is a need to improve the manufacturing of these therapies, to increase yield and lower cost without compromising quality.

During this two-year project, Touchlight, the CGT Catapult and Complement Therapeutics will combine their expertise in gene therapy development and manufacturing to develop an innovative recombinant adeno-associated virus (rAAV) production process.

The project will use Touchlight’s enzyme-based DNA manufacturing platform to produce doggybone DNA (dbDNA™). dbDNA can be produced significantly faster than plasmid DNA which is more commonly used to manufacture rAAV gene therapies. The collaborators hope that, during the commercialisation of gene therapies, this approach will ultimately lower the cost of manufacturing AAV as well as have the additional benefit of reducing environmental burden, compared with manufacturing plasmid DNA.  

The team will use dbDNA to produce rAAV which, in turn, will be used to manufacture Complement Therapeutics’ gene therapy candidates. CGT Catapult will optimise its rAAV manufacturing and analytical platform to support this manufacturing process.

The project will enable CGT Catapult to support other rAAV manufacturers around the UK to establish their own dbDNA-based manufacturing processes. By helping gene therapy developers improve their manufacturing, this has potential to make these therapies more affordable and accessible.

Karen Fallen, Chief Executive Officer of Touchlight, said: “We are excited to combine our dbDNA technology with those of Complement Therapeutics and CGT Catapult to develop an innovative solution to AAV production. dbDNA has the potential to improve the productivity and thus, the cost of AAV manufacture, while also eliminating bacterial impurities.”

Rafiq Hasan, Chief Executive Officer of Complement Therapeutics, said: “We are looking forward to this collaboration with colleagues from Touchlight and the CGT Catapult in exploring the potential of this innovative dbDNA technology in the manufacture of our AAV gene therapy candidates.”

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “Building on Touchlight’s pioneering dbDNA platform and Complement Therapeutics’ expertise in gene therapies, we hope to develop an innovative process that streamlines viral vector manufacturing and so helps to reduce the cost of advanced therapies. We look forward to working with Touchlight and Complement Therapeutics, both experts in advanced therapies, on this valuable project.”

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About Touchlight

Touchlight is a privately-owned CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA™) to enable the development of genetic medicines. Touchlight provide rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform is being utilised by multiple clients in clinical studies and enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through development and supply, to licencing and tech transfer for use in-house.

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry 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. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/. 

Contact: Alice Deeley, communications and content manager, alice.deeley@ct.catapult.org.uk / April Six cgtcatapult@aprilsix.com

About Complement Therapeutics

Complement Therapeutics 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 GA, 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 

Munich, Germany – 14^th December 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the formation of its Medical Advisory Board which will help guide the development of the company’s innovative therapeutic pipeline including its lead investigational product CTx001, a gene therapy for geographic atrophy.

“The establishment of this medical advisory board with distinguished specialists will provide CTx with invaluable guidance across various concepts including ophthalmology, complement biology, as well as in our preclinical and clinical development activities. We are delighted that these leading experts have agreed to join the team and assist the company as we progress our lead asset, CTx001, towards the clinic with a strong development plan.” said Parisa Zamiri, MD, Ph.D, Chief Medical Officer of Complement Therapeutics.  

The Medical Advisory Board consists of six esteemed members, led by Chair, Arshad Khanani, MD, MA, FASRS. With the extensive experience and deep expertise our advisory board members, the formation of this board highlights CTx’s commitment to advance its pipeline of products and deliver therapies for diseases driven by complement system dysregulation.

“I am thrilled to chair the medical advisory board of Complement Therapeutics comprising of international experts in dry age-related macular degeneration. Gene therapy has the potential to shift the treatment paradigm for geographic atrophy and I am looking forward working with the advisory board members to help Complement Therapeutics with the development of CTx001.”, said Arshad M. Khanani, MD, MA, FASRS, Chair of the Medical Advisory Board.

Medical Advisory Board Members: 

Arshad M. Khanani, MD, MA, FASRS: Dr. Khanani is the Chair of the Medical Advisory Board and the Managing Partner, Director of Clinical Research and Director of Fellowship at Sierra Eye Associates. Additionally, Dr. Khanani is also a Clinical Associate Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani has served as a principal investigator for more than 100 clinical trials and has authored more than 100 scientific publications. He has served as the Lead Principal Investigator for multiple gene therapy trials and is a part of numerous scientific advisory boards. Dr. Khanani is an elected member of the Macula Society, Retina Society and has received numerous awards including the Nevada Business Magazine Healthcare Heroes Physician of the Year award (2019), the Senior Honor Award from the American Society of Retina Specialists (ASRS) and the prestigious ASRS President’s Young Investigator Award in 2021.

Robyn Guymer, MD, Ph.D: Professor 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 400 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 and international working groups including the Ryan AMD initiative and the International Classification of Atrophy (CAM) group. 

Jeffrey S. Heier, MD: Dr. 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 Past 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 K Kaiser, MD:  Dr. Kaiser, is the director of Cole Eye Reading Center, has participated in numerous clinical trials as Study Chair, Executive Committee member, or principle investigator, and has been National Institute of Health RO1-funded. 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 the American Academy of Ophthalmology with a Lifetime Achievement Award and the American Society of Retina Specialists with Senior Honor Award. He has been listed as one of the “Best Doctors in America” since 2002 and has appeared on the Ophthalmologist’s “Power List” as one of the top 100 most influential people in the world of ophthalmology.

Eleonora Lad, MD, Ph.D: Dr. Lad is the Vice Chair of Ophthalmology Clinical Research at Duke University and specializes in the diagnosis and treatment of macular diseases. She is a clinician scientist and retinal ophthalmologist with the primary goal of developing novel strategies for early diagnosis and treatment of AMD and other retinal degenerative disease. Dr. Lad is the recipient of various awards, including the VA Merit Award I01, Patient-Oriented Research Career Development (K23) Award from the National Eye Institute, the 2016 Research to Prevent Blindness Ernest & Elizabeth Althouse Special Scholar Award, the 2016 ARVO/Alcon Early Career Clinician-Scientist Research Award, Heed Foundation award, and the Duke Institute for Brain Sciences incubator award. She is a member of the Macula Society, Retina Society, American Academy of Ophthalmology, Association for Research in Vision and Ophthalmology, International Society for Eye Research, Society of Heed Fellows, Society for Neuroscience and American Society for Neural Therapy and Repair.

David Steel, MD: Professor Steelis a Consultant Vitreoretinal Surgeon at Sunderland Eye Infirmary, as well as Honorary Professor of Retinal Surgery at the Bioscience Institute at Newcastle University and Honorary Visiting Professor of Ophthalmology at Liverpool University. Professor Steelhas over 25 years-experience of retinal surgery, over 300 peer reviewed publications with above 11,000 citations, and an H index of 54. He is immediate past President of the British and Eire Association of Vitreoretinal Surgeons (BEAVRS), board member of the Euretina vitreoretinal surgery and research committees, and a board member of the Club Jules Gonin of retinal specialists.

–The End– 

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 GA, 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. 

— Ends — 

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

Company Contact 

Dr Rafiq Hasan, CEO 
Complement Therapeutics Ltd 
Email: info@complementtx.com 

Munich, Germany – 09 November 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the enrolment of their first participant in the United States, an important milestone for the i-GAIN natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD).

The i-GAIN (investigating Geographic Atrophy Insights) study is a non-interventional study for participants who have a confirmed diagnosis of GA. The study, which has surpassed 100 participants in the UK, will now expand to include 10 centres in the United States. i-GAIN is designed to evaluate the relationship between genetics, blood biomarkers evaluated using the proprietary Complement Precision Medicine (CPM) Platform, and phenotypic changes in the eyes of people with GA.  Data from the i-GAIN study will ultimately support the clinical development of CTx001, an innovative gene therapy asset for the treatment of GA, enabling the identification and stratification of patients with complement-driven AMD for future interventional studies.

Dr Parisa Zamiri, Chief Medical Officer at Complement Therapeutics said, “Achieving this milestone is a great step in expanding our study and ensuring we capture meaningful, clinically relevant data to better understand geographic atrophy. We look forward to analysing this extensive database which will provide deeper insights into how the disease progresses.”

“An expanded natural history study will provide an in-depth, data-driven comprehension of a complex and heterogeneous disease that is GA, which will contribute to the clinical development of our innovative complement-targeting gene therapy approach to provide optimised solutions for patients,” said Dr Rafiq Hasan, Chief Executive Officer at Complement Therapeutics.

About the i-GAIN Study

i-GAIN is a multicentre, prospective natural history of people over 18 who have an established clinical diagnosis of GA. No investigational medications or treatments will be provided, as it is a non-interventional study. The study is expected to enrol approximately 250 patients across 12 sites in the United Kingdom and 10 sites in the United States. Patients will undergo assessments at baseline, 6 months and 12 months. For more information about enrolling in the study, please email iGAIN@complementtx.com citing trial identifier number NCT05797896.

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 GA, 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.

— Ends —

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

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com

Munich, Germany – 3^rd August 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dr Parisa Zamiri as its Chief Medical Officer, effective immediately. Dr. Zamiri brings with her extensive experience in biopharmaceutical and small molecule drug discovery and development, drug and device safety, pharmacovigilance, and biomarker development across various therapeutic areas.

Dr. Zamiri joins CTx from Graybug Vision, Inc., where she held the position of Chief Medical Officer and was responsible for all clinical, statistics, regulatory and medical affairs activities, successfully completing phase II development of their lead asset for wet age-related macular degeneration. Prior to Graybug, Dr. Zamiri held the position of Vice President, Global Head of Clinical Development and Therapeutic Area Head for Ophthalmology at Novartis Pharmaceuticals where she oversaw the design and execution of Phase 2b-4 clinical trials in ophthalmic indications including dry eye, retinitis pigmentosa, and age-related macular degeneration.

Dr. Zamiri is a physician-scientist who received her medical degree from the King’s College Hospital, University of London prior to her ophthalmology residency at the North Thames Rotation, London. She then obtained her Ph.D. in ocular immunology at the Schepen’s Eye Research Institute of Massachusetts Eye and Ear, a Harvard Medical School affiliated institute.

“We are excited to welcome Parisa to the CTx team as CMO,” said Dr Rafiq Hasan, Chief Executive Officer. “Parisa’s clinical experience and deep expertise in ophthalmic clinical development will be crucial as we progress with the development of our novel pipeline assets, particularly CTx001 for the treatment of Geographic Atrophy secondary to AMD as well as the ongoing i-GAIN natural history study. We are thrilled to have her on board to support our vision of developing the next generation of complement medicines.”

“I am excited to join CTx to develop medicines for the underserved and ever-growing population with age-related macular degeneration. CTx001 as a single administration gene therapy has the potential to revolutionise the treatment of GA by targeting the complement system. The encouraging results from preclinical studies have shown significant complement modulation and have the potential to offer hope for millions of GA patients worldwide who currently have limited treatment options.” said Dr Parisa Zamiri, Chief Medical Officer. “With its innovative approach, CTx001 has the potential to transform the treatment landscape for GA and improve the quality of life for those affected by this debilitating condition.”

About Complement Therapeutics GmbH:

Complement Therapeutics GmbH (CTx) is a German headquartered 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 GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK.

–Ends–

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

Company Contact

Dr Rafiq Hasan, CEO and Managing Director

Complement Therapeutics GmbH

Email: info@complementtx.com

Munich, Germany – 13^th June 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the opening of their laboratory at Stevenage Bioscience Catalyst (SBC).  

The state-of-the-art laboratory facility marks a significant milestone for CTx as it expands its research and development capabilities. Equipped with cutting-edge technologies and equipment, the lab will serve as a hub for advancing the development of CTx’s pipeline assets. 

“We are thrilled to announce the opening of our new lab at Stevenage Bioscience Catalyst,” said Dr Dennis Keefe, Chief Scientific Officer of Complement Therapeutics. “This facility will be instrumental in accelerating our research efforts and driving innovation in the field of complement-mediated diseases. With the support of our growing talented team and the collaborative environment fostered at SBC, we are well-positioned to make significant progress in developing novel therapeutics.”

Dr Sally Ann Forsyth OBE, CEO, Stevenage Bioscience Catalyst, said: “We are delighted that Complement Therapeutics has joined our world-class cluster of excellence which accelerates the translation of cutting-edge science to improve people’s health and the quality of their lives. We wish the team every success as they continue to build potentially transformative therapies.” 

The strategic location of the lab within the Stevenage Campus provides CTx with access to a vibrant ecosystem of leading researchers and industry experts. This proximity to scientific expertise and the potential for collaborative partnerships will enhance CTx’s ability to translate scientific discoveries into groundbreaking treatments for diseases with high unmet clinical need.  

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered 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 GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

About Stevenage Bioscience Catalyst

Stevenage Bioscience Catalyst is a world-leading cluster of global significance and located at the centre of one of the largest groups of cell and gene therapy companies in Europe. It provides a supportive environment to help organisations grow by providing access to specialist equipment, mentoring and finance suited to their stage of development.  Since its opening in 2012, occupier companies have secured £2.9bn in finance making the cluster one of the most attractive for investment in biotechnology in the UK.

–Ends– 

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

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

Munich, Germany – 27^th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dominic Moreland as its Chief Financial Officer. Dominic brings with him extensive experience in finance and operations, having held senior leadership roles in several biotech companies previously.  

Dominic is a seasoned biopharmaceutical executive with many years experience in the sector and previously served as the finance lead at Autolus Therapeutics through the company’s IPO and NASDAQ listing. He led the MBO and subsequent trade sale of a division of Genzyme Therapeutics UK and prior to that held finance positions with Baxter Healthcare and Zeneca. Dominic is a Chartered Accountant and holds a B.Sc from the London School of Economics. 

“We are thrilled to welcome Dominic to the Complement team as CFO,” said Rafiq Hasan, Chief Executive Officer. “Dominic’s experience in financial management will be invaluable as we continue to grow the organisation and develop our pipeline. He played a critical role in the recent successful Series A funding round and we are excited to have him on board to help transform the treatment landscape for complement-mediated diseases.”  

“Joining Complement Therapeutics at this stage in the company’s development is a truly exciting opportunity. I believe the team has the potential to make a real difference in the lives of patients with complement-mediate diseases, and I am delighted to be part of it. I look forward to working with the great team we have assembled and building a strong financial foundation for the company as we progress to the clinic.” said Dominic Moreland. 

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered 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 GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

–Ends– 

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

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

Munich, Germany – 20^th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced that pre-clinical data for its lead asset, CTx001, a gene therapy focused on treating geographic atrophy, a form of dry age-related macular degeneration, will be featured in posters at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2023 to be held on 23-27^th April 2023 in New Orleans, USA.  

ARVO Poster Details: 

Title: CTx001, a gene therapy for the treatment of geographic atrophy in aged-related macular degeneration 

Session: 414, Gene and Cell Therapy, April 26, 2023, from 10:30 AM to 12:30 PM 

Presentation Number: #3852 

Poster Board Number: #B0132 

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered 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 GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

–Ends– 

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

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

• Round led by Gimv, a Belgian based private equity and venture capital firm
• Round comes just 1 year after raising €5 million seed funding in February 2022
• Company aims to transform the treatment of complement mediated conditions

Munich, Germany – 17th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement mediated diseases, today announced the completion of a €72 million Series A financing. The round was led by Gimv, a Belgian-based private equity and venture capital fund, co-led by Forbion as existing investor and further joined by BioGeneration Ventures (BGV), Panakès Partners, Cambridge Innovation Capital (CIC), Hadean Ventures and Seroba Life Sciences.

With this new round of financing, CTx will continue the development and complete a Phase Ib clinical proof of concept of its lead product CTx001. CTx001 is a highly innovative AAV gene therapy for the treatment of Geograpic Atrophy (GA) secondary to dry age-related macular degeneration (dry-AMD). Additionally, proceeds from this financing will be deployed to grow its laboratory-based activities in Stevenage (UK), evaluate CTx’s pipeline assets for non-ocular indications as well as further develop the novel Complement Precision Medicine (CPM) platform.

CTx was spun out of the University of Manchester with initial funding from BGV in 2021 and subsequently received €5 million seed funding in February 2022 from Forbion and BGV. With that funding, CTx has advanced CTx001 through preclinical proof-of-concept, secured an Innovation Passport by the Medicines and Healthcare products Regulatory Agency (MHRA) and initiated a non-interventional natural history study in the UK (i-GAIN). The i-GAIN study results will help support the clinical development planning for CTx001.

“With a potentially highly differentiated lead asset combined with a precision medicine approach, we are excited by the opportunity to further develop CTx001 for the treatment of GA through to the clinic.” said Dr Rafiq Hasan, CEO and Managing Director at Complement Therapeutics GmbH. “The support of this broad syndicate enables us to generate additional data demonstrating CTx001’s unique and differentiated mechanism of action, with the potential to transform the treatment landscape in geographic atrophy.”

The recent FDA approval of the first intravitreal treatment for GA is a significant milestone for GA patients and the retina community, and further validates the critical role that the complement system plays in the development and progression of GA whilst highlighting the importance of targeting complement as a therapeutic strategy. CTx001 gene therapy with its novel mechanism of action has the potential to provide superior efficacy compared to competitive drugs and to lower the burden of treatment among patients through a “one and done” approach and thereby transforming the treatment landscape in GA.

Michaël Vlemmix, Principal in the Life Sciences platform of Gimv said: “We are proud to have been able to build this syndicate and look forward to supporting Complement Therapeutics in its next phase of development. The company and its team combine deep research insights, strong industry background, and a robust understanding of complement-mediated conditions, in particular GA secondary to AMD. These strengths, coupled with a focus on addressing the significant unmet need in GA, positions the company to change the way the disease is addressed and potentially achieve meaningful therapeutic impact.”

“We are delighted with the rapid progress made by Complement Therapeutics in the last 12 months. Patients impacted by complement-mediated diseases often have to cope with debilitating symptoms throughout their lifetime and this can lead to a significant burden on them and their families. We look forward to supporting the Company as it drives forward a pipeline of novel assets addressing these unmet needs in complement-mediated diseases” said Dr Dmitrij Hristodorov, Partner, Forbion.

Alongside the financing, Michaël Vlemmix (Gimv), Rob Woodman (Panakès), Anne Horgan (CIC) and Roger Franklin (Hadean Ventures) will join the board as new members.

About Complement Therapeutics GmbH:

Complement Therapeutics GmbH (CTx) is a German headquartered 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 GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK.

–Ends–

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

Company Contact

Dr Rafiq Hasan, CEO and Managing Director Complement Therapeutics GmbH
Email: info@complementtx.com

London, UK – March 29^th 2023 – Complement Therapeutics Ltd (CTx) and Pharmaron are delighted to announce a strategic partnership for the Development and Clinical Manufacture of lead investigational product (CTx001) – a Gene Therapy for the treatment of Geographic Atrophy (late dry age-related macular degeneration), which causes significant vision loss and is estimated to affect 5 million people globally.

The project commenced in December 2022 with initiation at Pharmaron’s state-of-art gene therapy clinical development and GMP manufacturing facilities in Liverpool, UK. The Pharmaron CMC team has a wealth of technical know-how and experience in the development of ocular gene therapy medicines. 

CTx001 is in pre-clinical development as an Adeno Associated Virus (AAV) based gene therapy for the treatment of Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). CTx001 harnesses the unique mechanism of action of a highly potent complement regulator to maximise efficacy in a broad range of patients with complement-driven GA. This partnership will allow the delivery of clinical-grade drug products for the supply for first-in-human clinical trials anticipated to commence in H2 2024.  

Dr. Rafiq Hasan, CEO of Complement Therapeutics said, “Collaborating with Pharmaron is a critical component in our strategy to bring CTx001 through clinical proof of concept. Their track record in delivering gene therapies for ophthalmic diseases, technical expertise and state-of-the-art facilities make them an ideal partner in delivering a robust and scalable CMC platform. Our team looks forward to a productive and collaborative partnership, accelerating the development of CTx001 in a cost-effective manner, with the ultimate aim to improve the quality of life of patients with GA.”

Dr. Derek Elliison, VP Biologics Services Europe, Pharmaron Biologics & CGT, commented, “I am extremely pleased that Complement Therapeutics, has recognised Pharmaron’s advanced analytical and process development capabilities to develop their lead investigational product. This project is a great fit for our multi-disciplinary expertise team given the many years’ prior experience working on gene therapy ophthalmic indications out of our Liverpool site and we are excited at the opportunity to make a difference in fighting this debilitating cause of vision loss in such a large patient group.

About Complement Therapeutics Ltd:

Complement Therapeutics Ltd (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.

The Company’s lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs 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 the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

Contacts

For further information please contact:

Pharmaron:

Ellen Cabral
Senior Marketing Director
Tel: +1 617 901 2216,

Email:ellen.cabral@pharmaron.com

Complement Therapeutics:

Dr Rafiq Hasan

CEO

Email: info@complementtx.com