150th Antibody Humanization project

Fusion Antibodies, a world leading CRO, has today announced that they have successfully completed their 150th Antibody Humanization project as part of their Antibody Engineering offering.

Humanization is a critical process in the development of therapeutic drugs where the antibody has been derived from a non-human source.

Paul Kerr, CEO of Fusion Antibodies said, “We developed the multiplex and standard CDRx™ platforms in 2012 and have been humanizing antibodies from multiple species since then. We are proud to have reached our 150th Humanization project.

“I am delighted to see more than half of our first 15 clients advancing to clinical stages some as far as Phase 2. The importance of Antibody Humanization cannot be underestimated to ensure manufacturability and increasing success at later stages.”

CDRx™  was launched by Fusion Antibodies in 2012. It generates a matrix of humanized variants from the parental antibody increasing the likelihood of selecting the optimal candidate and thereby accelerating the project to clinical trials. Fusion Antibodies are experienced in delivering successful humanization projects. These projects can range from one single sequence to humanizing hundreds of molecules from B-Cell repertoires.

 

Fusion Antibodies introduces novel Affinity Maturation platform (RAMP™)

Building upon over 18 years’ experience in antibody engineering and humanization we are proud to introduce our novel Affinity Maturation platform (RAMP™) for the rapid optimization of your antibody.

Somatic hypermutation is the natural process by which immunoglobulins undergo affinity maturation and selection, as part of the adaptive immune response, in order to increase their binding affinity to their target antigen

Fusion Antibodies’ RAMP™ platform adopts lessons from nature and combines a rational approach to library design, with rapid in silico selection for both improved binding potential and predicted stability. The result is that we will generate an enriched ‘micro-library’ of variants with improved stability and affinity for the target.

We go the extra mile to deliver exceptional antibodies by applying our expert knowledge and cutting edge technologies. Our RAMP™ platform is designed to accelerate your lead selection program, providing you with the best chances of success in the clinic.

For more information on our Affinity Maturation service (RAMP™) read more here or contact us today!

Ground Breaking New Saliva Diagnostic Test Set to Help Eliminate Malaria

ERADA Technology Alliance Ltd (ERADA), pioneers of innovative, rapid diagnostic solutions for early detection of infectious diseases, have announced the imminent launch of a world first diagnostic saliva test for malaria.

The saliva-based diagnostic tool, to be marketed by ERADA as a Saliva-based Malaria Asymptomatic and Asexual Rapid Test (SMAART) for sub-clinical infection, is set to transform malaria detection worldwide in the fight against one of the globe’s most deadly diseases. Malaria, globally kills an estimated 435,000 each year, mostly children under the age of five, mainly in Sub-Saharan Africa. 1 

The SMAART detection tool is the invention of leading, U.S based, researchers in the field of malaria diagnostics whose study is published worldwide today, January 2 in the international journal, Science Translational Medicine

ERADA’s innovative solution is easy- to-use, as it includes a simple device for standardized collection of saliva that can be implemented in the community by health care professionals, teachers and parents; contrasting with invasive blood tests, which must be administered by trained clinicians. Other drawbacks to blood tests include cultural ‘blood taboos’ existing in many countries whilst, furthermore, skin-prick tests are often stressful for children and parents. 

Existing tests using blood may be invariably less reliable because sub-clinical infections with malaria-carrying parasites can be missed, leading some patients to come down with the disease, without knowing they have already been infected.

ERADA’s SMAART-1, easy-to-use saliva test, leads to early detection, treatment and prevention of the disease as well as reducing further transmission of malaria.

ERADA’s SMAART saliva test detects a unique bio-marker from female parasites circulating in an infected human who is asymptomatic, but is carrying the parasite and likely to come down with malaria within a week. Early, sub-clinical detection of malaria is crucial to malaria eradication because individuals who carry the parasite without exhibiting symptoms, known as carriers, are the reservoir that leads to infection of mosquitoes and transmission of the disease. Detecting the presence of the parasite before symptoms appear can save lives because malaria visible disease only erupts a couple of days after the mosquito bite.

The SMAART detection tool works by detecting a novel bio-marker for Plasmodium falciparum parasites. In some areas of the world, the parasites have acquired a mutation and are therefore no longer detected by current blood-based tests. But ERADA’s saliva test detects an essential protein the parasite needs for survival, which should avoid the problem of influence from the mutation and keep the test effective long-term.

 “As someone who has suffered from malaria, I know first-hand that if the parasite had been detected early, I could have been treated and cured before the symptoms of the disease made me unwell,” Dr Benji Pretorius, ERADA’s founder and Managing Director says.”

Dr Pretorius continues, “As a practicing clinician myself and following my personal experience of this debilitating disease, I was spurred on to work with my colleague Dr Richard Schmidt in our small community, Musina, in South Africa, together with a global team of scientists.” Dr Pretorius continues, “Our vision is to bring to market ERADA’s SMAART diagnostic tool as quickly as possible in the belief that it will go on to save literally millions of lives in the future.”

The World Health Organization’s recently published World Malaria Report 2018 reinforces the message that the world is currently behind 2020 milestones of the WHO Global Technical Strategy for Malaria 2016–2030. 1Reduction in malaria cases has stalled and of particular concern is the report’s finding that, in 2017, there were an estimated 3.5 million more cases of malaria in the 10 highest burden African countries. 1,3 

“The introduction of SMAART is going to play a major part in achieving effective diagnostic testing and surveillance; as well as prevention and treatment of this disease, and therefore will be a major catalyst in meeting the WHO’s 2030 target to reduce malaria incidence and mortality by 90% ,” Dr Pretorius says. 2 

Research and development of this new saliva test was assisted with funding from the Bill & Melinda Gates Foundation in 2014. This was augmented by the technical expertise of Maryland Innovation Initiative and the Dinglasan Malaria laboratory. This world-first patented technology is licensed exclusively to ERADA Technology Alliance Ltd by Johns Hopkins University and ERADA will bring this innovative diagnostic tool to market in partnership with the Dinglasan Malaria Laboratory based at the University of Florida, U.S;Oasis Diagnostics® Corporation, a U.S based oral diagnostic testing company; Fusion Antibodies in the UK and Synergyworx International Holdings, an international investee company with strong humanitarian health interests in Africa.

For more information, contact Joanna Scott at pressoffice@eradatechnology.com or visit www.eradatechnology.com

 References

  1. World malaria report. Geneva: World Health Organization; 2018: Available athttps://www.who.int/malaria/publications/world-malaria-report-2018/en/
  2. Global Technical Strategy for Malaria, 2016-2030. Geneva: World Health Organization; 2015: Available at https://www.who.int/malaria/publications/atoz/9789241564991/en/
  3. https://www.who.int/news-room/detail/19-11-2018-who-and-partners-launch-new-country-led-response-to-put-stalled-malaria-control-efforts-back-on-track

About ERADA Technology Alliance Ltd (ERADA)

ERADA Technology Alliance Ltd (ERADA), was founded by Dr Benji Pretorius and Dr Richard Schmidt, located in Musina, South Africa, and pioneers of innovative, rapid diagnostic solutions for early detection of infectious diseases, including malaria.  Dr Pretorius, the company’s Managing Director, himself an experienced medical practitioner, is an expert in the field of malaria management and has a long track record of working in the pharmaceutical, health, wellness and fitness industry. 

Fusion Antibodies and Analytics Engines to incorporate artificial intelligence into its world class antibody humanization service.

Fusion Antibodies plc, experts in antibody engineering and Analytics Engines, an advanced data analytics company, have announced a strategic collaboration to incorporate machine learning (ML) and artificial intelligence (AI) into Fusion Antibodies’ CDRx™ humanization platform. This collaboration will boost Fusion Antibodies’ continual efforts to improve its algorithms to understand the structure/function relationship of its target antibodies. The CDRx™ platform makes it possible to perform multiple virtual experiments with panels of selected antibodies to discover properties that meet desired functionality and developability requirements with the long-term goal of reducing development costs and accelerating timelines so that novel antibody drugs can reach patients faster. 

“We are delighted to have the opportunity to collaborate with the team at Analytics Engines to incorporate artificial intelligence into our CDRx™ platform. At Fusion Antibodies we want to keep differentiating our product to make sure it’s the best humanization platform in the world, and that’s our goal, keeping ourselves in front. Collaborating with Analytics Engines will allow us to drive up our quality and add more certainty and manufacturability to the products,” said Paul Kerr, CEO of Fusion Antibodies. 

“Analytics Engines are excited to be part of this collaboration, assisting Fusion Antibodies in taking the CDRx platform to the next level. Using our expertise in Machine Learning and AI, Fusion Antibodies will be able to create ML models to continually improve their antibody humanization process” said Aislinn Rice, CEO of Analytics Engines.

About Analytics Engines

Analytics Engines is a global leader in the delivery and implementation of advanced Data Analytics Solutions.  Headquartered in Belfast, Analytics Engines employs 20 people with expertise in data infrastructure, data engineering, artificial intelligence and machine learning, data analytics and visualizations.

Analytics Engines technology and expertise enables organisations to convert data into valuable business insights. We have developed a range of high-value solutions within the healthcare, government and private sectors. Built upon the Analytics Engines XDP™ data platform, the company has also developed a range of products for smart cities, healthcare, and governmental bodies.

To find out how Analytics Engines can help you gain value from you data visit us at – www.analyticsengines.com

Read more here or contact us today!

 

Towards translational ImmunoPET/MR imaging of invasive Pulmonary Aspergillosis: The Humanized Monoclonal Antibody JF5 detects Aspergillus Lung Infections in Vivo

Objective

Invasive pulmonary aspergillosis (IPA)is a frequently fatal lung disease of neutropenic patients caused by the ubiquitous airborne fungus Aspergillus fumigatus. Diagnosis of IPA is a major challenge as clinical manifestations of the disease are nonspecific, and methods for the detection of circulating biomarkers such as β-D-glucan or galactomannan (GM) in the bloodstream lack specificity or sensitivity. 

In a previous study, ISCA Diagnostics and co-workers developed a novel non-invasive procedure for IPA diagnosis based on antibody-guided positron emission tomography and magnetic resonance imaging (ImmunoPET/MRI) using a [64Cu]DOTA-labelled mouse monoclonal antibody (mAb), mJF5. The highly specific tracer allows repeated imaging of A. fumigatus lung infections and differentiation of IPA from pulmonary inflammation and from infections caused by bacteria.

To enable translation of the tracer to a clinical setting, ISCA Diagnostics’ aim was to develop a humanised version of the antibody JF5 (hJF5), and to evaluate its performance in pre-clinical imaging of lung infection using a [64Cu]NODAGA-hJF5 tracer.

Process

Fusion Antibodies developed a humanized version of JF5 (hJF5), using CDR grafting and applied its proprietary CDRx™ platform. Fusion Antibodies delivered the following package of Antibody Humanization services:

Results and conclusion

The results show both mJF5 and hJF5 bind to the antigenic determinant β1,5-galactofuranose (Galf) present in the target mannoprotein antigen. ELISA tests reveal unlabelled humanized hJF5 and hJF5-NODAGA antibodies exhibit increased binding with the purified mannoprotein antigen compared to murine mJF5 and mJF5-NODAGA. Furthermore, uptake of humanized hJF5-NODAGA in the lungs of infected mice was significantly higher compared to murine mJF5. This trend in uptake was further evidenced by ex vivo autoradiography of the lungs of infected mice.

Fusion Antibodies successfully developed a humanized version of the Aspergillus-specific mAb JF5. The improved imaging capabilities of hJF5 provides an excellent platform for clinical studies of IPA detection using antibody-guided molecular imaging (Thornton [2018] Frontiers in Microbiology 9: 691).

The JF5 humanization project represents another successful project for Fusion Antibodies and is a case study example of the robust nature of Fusion Antibodies’ CDRxTM Humanization platform.

Fusion Antibodies announces partnership with Protein Alternatives to develop world class humanized antibodies for therapeutic development

Fusion Antibodies plc, a UK-based contract research organisation and Protein Alternatives, a biotechnological organisation, are pleased to announce their delight at entering into a revenue share partnership to develop world class humanized antibodies for therapeutic development. Fusion Antibodies will apply its proprietary CDRx™ platform to humanize a Protein Alternatives’ lead monoclonal antibody to bring them one step closer to clinical trials.

“We are delighted to have the opportunity to collaborate with the team at Protein Alternatives and look forward to delivering high quality humanized antibodies using our CDRx™ platform which now incorporates our ADD™(Antibody Developability by Design) to ensure we find the best lead candidate in functionality and manufacturability. The work Protein Alternatives is doing on the development of novel targeted therapies for the treatment of late stage metastatic cancer is cutting edge and it is a privilege to be involved,” said Paul Kerr, CEO of Fusion Antibodies.

“By targeting the RGD domain of the Cadherins (CDHs), the tissue-specific activators of metastasis-promoting integrins, we discovered a novel and highly promising way to combat late stage, metastatic cancer”, said Juan Ignacio Imbaud, COO of Protein Alternatives. “We are excited to initiate the preclinical development of our anti CDH17-RGD specific monoclonal antibody PA-0661 in partnership with Fusion Antibodies. This strategic collaboration with the antibody humanization experts at Fusion will be essential for our successful progression to the clinic”.

About Fusion Antibodies plc

Fusion Antibodies is a Contract Research Organisation (CRO) located in Belfast, Northern Ireland, UK. With over 17 years of experience in antibody development within the therapeutic & diagnostic industry and >110 humanization projects successfully completed to date (from Rabbit, Rat, Mouse, Chicken, Llama), including multiple antibodies in clinical and pre-clinical trials. Fusion Antibodies have extensive experience in accelerating therapeutic drug research towards and into the clinic.

Fusion Antibodies has the knowledge and expertise to build and deliver a tailored package of the services required to achieve outstanding results. Fusion Antibodies provides Antibody Humanization of Monoclonal Antibodies, using their next generation in silico CDRx™ technology, they have modernized CDR grafting technique which now incorporates ADD™ Antibody Developability by Design. Fully humanized monoclonal antibodies are an essential step in the progression of therapeutic drugs to the clinic, and the in-house expertise at Fusion Antibodies ensures development success. Fusion provide a range of services from Cell line Development, RAMP™ Rapid Affinity Maturation Platform and cGMP services to take antibodies from Discovery to the Clinic.

About Protein Alternatives and its specific therapeutics in oncology

Founded in 2006 and based in Tres Cantos, Spain, Protein Alternatives (ProAlt) is leading the development of novel targeted therapies for the treatment of late stage metastatic cancer with current limited treatment options and low survival rates. At the end of 2017 ProAlt has selected PA-0661 as development candidate for the treatment of metastatic colorectal cancer (mCRC). PA-0661, a monoclonal antibody directed against the Cadherin 17-RDG domain, prolonged survival significantly and achieved complete tumor eradication in a highly aggressive metastatic CRC tumor animal model.


Contact Information:

Fusion Antibodies plc
1 Springbank Road
Springbank Industrial Estate
Belfast, UK
BT17 0QR
Contact: Dr. Paul Kerr, CEO
Email: paul.kerr@fusionantibodies.com 
Website: www.fusionantibodies.com

Protein Alternatives SL (ProAlt)
Ronda de Poniente 16
Tres Cantos, 
Madrid, Spain
28760
Contact: Dr. Juan Ignacio Imbaud, COO
Email: jimbaud@proteinalternatives.com
Website: www.proteinalternatives.com

Non-phosphorylated and Phosphorylated Signal Transduction Peptide (STP) of Tissue Factor (TF) in Urine are Potential Biomarkers for Bladder and Colon Cancer.

Objective

Tissue factor (TF, CD142) is commonly associated with the initiation of blood clotting. Many studies have shown that solid cancers including colon, breast, prostate, bladder and pancreas express high levels of TF and there is evidence that TF plays an integral role in the carcinogenic process as well as in metastasis.

The objective of this study was to develop immunoassay methods to investigate the TF-STP (signal transduction peptide) domain in urinary microvesicles from healthy individuals and patients with various tumour types. Using immunological methods to quantitate unphosphorylated TF and TF phosphorylated at ser253 and ser258.

Process

Fusion Antibodies generated monoclonal antibodies (Anti-TF2 Mab and Anti-TF2-PSer253 Mab) to specifically target two peptides in the STP region of TF. Both polyclonal and monoclonal antibodies directed against various phosphorylated and unphosphorylated peptides were used to construct three ELISAs that specifically recognise unphosphorylated TF and TF phosphorylated at ser253 or at ser258. Urine samples were obtained from healthy individuals and from patients with various solid tumour types.

The results were presented as ng/ml of urine for each of the 3 anayltes in each sample. ROC curves were plotted for each diagnostic measurement and the area under the curve calculated. Optimal cut-off points were calculated from the ROC curves using the Youden Index. Sensitivities, specificities, positive predictive value (PPV) and negative predictive values (NPV) were calculated for each of the diagnostic measurements.

Results and conclusion

In summary, three highly sensitive ELISA assays were developed by Fusion Antibodies to quantitate unphosphorylated TF, TF-Pser253 and TF-Pser258 in urine. TF-Pser258 represents a potential new urinary biomarker for bladder cancer including early disease. Unphosphorylated TF is also a novel marker for advanced bladder cancer and their concurrent use may allow a nuanced approach to the diagnostics of bladder cancer from the outset. TF-Pser253 had a sensitivity of 71% and specificity of 69% at 0.55 ng/ml cut-off determined by ROC analysis. Suggesting that TF-Pser253 could be a promising urinary marker for early diagnosis of colon cancer.  

For more information:

Tam Herd CEO of C-Term Diagnostics will be presenting at the Annual Scientific and Standardization Committee meeting on July 18-21, 2018. 

Visit poster PB514 at the conference centre, Dublin or read more on our case study page!

Queen’s University Belfast researchers at the Centre for Cancer Research and Cell Biology (CCRCB) alongside Fusion Antibodies plc have secured a prestigious Medical Research Council (MRC) award to develop a new antibody drug for the treatment of pancreatic cancer.

Globally pancreatic cancer is still one of the most difficult cancers to treat, and new treatments are urgently required.

Recent statistics from Cancer Research UK shows that in the UK alone, almost 10,000 new cases are detected annually and the outlook for patients is much poorer than those suffering other cancers.

Queen’s researchers are addressing this gap by designing an antibody that specifically targets the surface of the cancer cells. Professor Dan Longley, Chair of Molecular Oncology at the CCRCB explains that, “this approach, called immunotherapy, has been heralded as a game-changing approach for other cancers such as skin melanomas, but new innovations are required to treat pancreatic cancer and this is the focus of our current work.”

To create the antibodies the Queen’s team will work with therapeutic antibody development specialists Fusion Antibodies plc to develop these prototype molecules.

Explaining the concept behind this new award, Professor Chris Scott, Chair of Pharmaceutical Biosciences at CCRCB at Queen’s University describes, “Pancreatic cancer is the 6th most common cause of cancer death in the UK.

“Our aim is to develop a new antibody drug that will re-arm and trigger the patients’ own immune systems to combat the disease. This exciting project is very much in line with the research ethos of Queen’s University, which is centred on Global Challenges. With this discovery, we hope to change the lives of people across the world who are diagnosed with pancreatic cancer.”

Dr Paul Kerr, Chief Executive at Fusion Antibodies said, “We are delighted to use our expertise in drug development and antibody engineering to collaborate with Queen’s University to generate new drug candidates for pancreatic cancer”.

This current project builds on a successful research programme funded by the Northern Ireland Health and Social Care Research & Development Division.

The research team are also kindly supported by generous donations through the Queen’s Foundation into pancreatic research. Speaking on behalf of this group, Mrs Sharon Martin said, “as part of our fundraising campaign for Queen’s we are organizing proceeds from the first night of the new play ‘Hello Georgie, Goodbye Best’ on the 22nd May, at the Strand Theatre in Belfast and would be delighted to see the support of the local community at this event.”

Notes to Editors

1. Professor Chris Scott from Queen’s University Belfast is available for interview. Bids to Sian Devlin at Queen’s Communications Office on: s.devlin@qub.ac.uk or tel: 028 9097 5292.

2. Media inquiries to Sian Devlin at Queen’s Communications Office on: s.devlin@qub.ac.uk or tel: 028 9097 5292.

3. For more information on Fusion Antibodies, please see www.fusionantibodies.com Media inquiries 028 90432800

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Fusion Antibodies has announced plans to create 28 new jobs. This recruitment drive, supported by Invest NI, will help Fusion Antibodies deliver its services to its growing international customer base.

Invest NI has offered Fusion Antibodies £213,000 towards its job creation and marketing activities.

Fusion Antibodies, Managing Director, Paul Kerr, said: “Invest NI continues to provide excellent support as we look to expand the business rapidly and to capitalise on our position as a successful international CRO providing a range of antibody engineering services.

“The work to more than double the capacity of our laboratory and office space is expected to be completed by the end of the summer, ahead of our original schedule. The new employees will include technically skilled staff working to deliver our current services to biopharma companies.

“We are also recruiting scientists with specialised skills to work in our new product development team on the establishment of our antibody affinity maturation service and the creation of a mammalian antibody library. In addition, our growth strategy, focused on reinvigorating and expanding our new business development and sales function, will benefit from further resource in this area.”

Invest NI, Director of Life Sciences, Grainne McVeigh, said “This expansion is an exciting milestone for Fusion Antibodies which is among a dynamic group of companies contributing to our growing Life and Health Sciences sector.

“Invest NI has been working alongside the business for many years and we are delighted to be helping Fusion Antibodies to scale up its workforce and target market opportunities with drug development and diagnostics companies across the globe.”

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We are delighted to showcase the progress of Phase 1 of our ambitious expansion project that is now well underway.

As many of you will remember, in December 2017 Fusion Antibodies became one of only three companies in Northern Ireland to trade on the London Stock Exchange. Here at Fusion, we wanted to take the opportunity to give an update on some of the exciting happenings that have been going on since then.

Through raising funds on the Stock Exchange, our intention was to secure additional space in the building on our existing site, enabling us to more than double our facilities and our intentions are to complete the fit out of the new laboratory by the end of 2018.

We are delighted to say that Phase 1 of our ambitious expansion project is well underway. Over the past month, there have been countless contractor’s, architects, builders and more, working tirelessly to turn a large empty warehouse space into a modern, colourful, comfortable open plan office space that perfectly shows off the culture of Fusion Antibodies. Although it is not completed, we are really pleased with the progress and we wanted to share a few pictures with you.

Let us know what you think!