Sengenics Announces New Research Collaboration with GSK Focusing on Immunology

Sengenics, the Functional Proteomics Company, announced today that it has entered into a research collaboration agreement with GlaxoSmithKline (GSK). The collaboration will combine Sengenics’ functional proteomics capabilities with GSK’s scientific expertise in immunology, especially in drug discovery.

The collaboration will leverage Sengenics’ proprietary KREX™ technology to validate novel autoantibody biomarkers in patients with autoimmune diseases. These biomarkers were identified using the IMMUNOME™ protein array, a KREX™-based array with functionally validated, full-length, correctly folded proteins.

Andrew Jackson, Global Business Unit Director – Pharma, Sengenics said, “We are very pleased to enter into this exciting research collaboration with GSK. We hope to be able to determine the diagnostic and therapeutic potential for certain immune-mediated diseases, since they are characterised by the presence of autoantibodies.”

About Sengenics

Sengenics is a Functional Proteomics company that leverages its patented KREX™ technology to discover autoantibody biomarker signatures for prediction of drug response and severe immune-related adverse events (irAEs). KREX™ can also be used to identify autoantibody biomarkers that may be used to diagnose cancer, autoimmune, neurodegenerative or infectious diseases with higher sensitivity and specificity than conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

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Sengenics Successfully Produces Functional COVID-19 Antigens and Makes Them Available for Research and Vaccine Development

Sengenics, a leading precision medicine company, today announced that the company has made full-length, correctly folded and functional COVID-19 antigens available for purchase for both research and vaccine development purposes. Sengenics has successfully expressed these antigens using the company’s patented and validated KREX™technology.

”The surge of COVID-19 infections has pushed us to accelerate the production of SARS-CoV-2 antigens using our patented KREX™ technology. We are now offering unencumbered access to these antigens for the global research community and are looking for collaborations in this space to develop a vaccine and accelerate characterisation of COVID-19,” said Dr Arif Anwar, CEO of Sengenics.

“The folded structure of a protein antigen is a key component of antibody recognition. The antigenic property of a protein is dependent on efficient epitope presentation and subsequent stimulation of B and T cells. However, since most antibodies are thought to recognise discontinuous epitopes on their target proteins, it’s critical that antigens used in serological assays or presented to B-cells for antibody-based vaccine development are in a natively-folded form. The use of our KREX™ technology for the production of the SARS-CoV-2 antigens will ensure these antigens are correctly folded, preserving all conformational antibody binding sites, and that they are highly purified, free from bacterial contaminants, ready for downstream applications,” said Professor Jonathan Blackburn, CSO of Sengenics.

KREX™-based COVID-19 antigens are now available for sale by Sengenics for both Research and Commercial use. Parties who are generating higher affinity monoclonal antibodies for commercial vaccine purposes or are interested in collaborating to develop antivirals for COVID-19 are invited to contact Sengenics at [email protected].

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Sengenics, a Leading Precision Medicine Focused Company, to Present at the Annual BIO CEO and Investor Conference

Sengenics, a leading precision medicine focused company, today announced that Dr Arif Anwar, CEO of Sengenics, will present a company overview at the 2020 BIO CEO and Investor Conference. The presentation will take place at 3:15 PM EST on Monday, February 10, 2020 in the Wilder room at the New York Marriott Marquis.

Dr Arif Anwar will present an overview of the commercialisation strategy of the company and applications of its patented KREX™ technology for autoimmune and cancer immunotherapy drug response and ADR prediction.

Sengenics is currently co-developing complementary and companion diagnostic tests for several autoimmune and cancer immunotherapy drugs through partnerships with top pharmaceutical companies. The company has commenced the process for obtaining FDA 510(k) approval for several of these tests and plans to launch them in 2020 and 2021.

Sengenics’ management team will also hold meetings with institutional investors and analysts from February 10 – 14 in New York. Accredited investors are invited to request a meeting during the conference through BIO’s One-on-One Partnering™ System.

About Sengenics

Sengenics is a precision medicine company that leverages its patented KREX™ technology to discover autoantibody biomarker signatures for prediction of drug response and severe immune-related adverse events (irAEs). KREX™ can also be used to identify autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions years before conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

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Sengenics, a Leading Commercial Stage Precision Medicine Focused Company, which Enables Pharma Companies to Identify Drug Responders, to Present at Biotech Showcase™ 2020

Sengenics, a leading commercial stage precision medicine focused company, today announced that Dr Arif Anwar, CEO of Sengenics, has been invited to present at the Biotech Showcase™ during the upcoming 38th Annual J.P. Morgan Healthcare Conference week in San Francisco.

Dr Arif Anwar will present an overview of the commercialisation strategy of the company, as well as applications of its well-differentiated and patented KREX™ technology for intra-disease stratification and autoimmune and cancer immunotherapy drug response prediction. The identity of the autoantibody biomarkers discovered from these applications can also guide drug development decision-making for the pharmaceutical industry, allowing for the early elimination of poor drug candidates. For clinical stage candidates, this can result in very significant cost savings as well as acceleration of the best candidates towards faster FDA drug approval. For commercially launched drugs, KREX™ offers unparalleled opportunities to gain market share by identifying new true responders.

Sengenics currently has partnerships with 9 out of the top 20 pharma to co-develop complementary and companion diagnostic tests for autoimmune and cancer immunotherapy drugs. The company has commenced the process for obtaining FDA 510(k) approval for several of these tests and plans to launch them in 2020. Sengenics’ key value drivers, which are derivatives from enhancing precision medicine, are primarily based on maximising the probability that drugs are prescribed only to patients who have a greater than 90% chance of responding to them. These new Sengenics tests offer a compelling business case for the pharmaceutical industry as well as medical insurance companies, whilst ultimately delivering upon the promise of precision medicine for autoimmune and cancer immunotherapy drugs.

Details of Sengenics’ presentation are as follows:

Event: Biotech Showcase™ 2020

Date: Tuesday, January 14, 2020

Time: 2:30 PM Pacific Time (5:30 PM Eastern Time)

Title: Realising the Potential of Precision Medicine for Autoimmune and Cancer Drugs using Sengenics’ KREX™ Technology

Location: Franciscan B (Ballroom Level), Hilton San Francisco Union Square – 333 O’Farrell Street

The presentation document will be available on the Sengenics website in the “Downloads” section on the same day.

About Sengenics

Sengenics is a functional proteomics company that leverages its patented KREX™ technology for production of full-length, correctly folded and functional proteins. KREX™ was invented and patented by Professor Jonathan Blackburn whilst he was a member of the faculty at the University of Cambridge.

The key application of KREX™ is the discovery of autoantibody biomarkers for two core medical use cases. Firstly, stratification of patients undergoing treatment with autoimmune or cancer drugs into responders, non-responders and those that may exhibit severe immune-related adverse events (irAEs). Secondly, identification of autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions years before conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

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Renal Cancer Research by Sengenics and the University of Leeds Awarded Early Detection Primer Grant Funding from Cancer Research UK

Sengenics, the functional proteomics company, together with researchers at the University of Leeds have been awarded an Early Detection Primer grant by Cancer Research UK to explore the use of tumour-associated autoantibodies in the early detection of renal cancer. Cancer Research UK’s Early Detection Primer Award scheme supports researchers at all stages to develop early, novel and outside-the-box ideas and collaborations to build and make progress in the Early Detection field.

The University of Leeds has established a public-private partnership between the proteomics team at Leeds and Sengenics through a Research Collaboration Agreement. Working with Sengenics as the industry partner, this collaboration will focus on discovery of novel biomarkers for renal cell carcinoma (RCC), with the goal of developing an autoantibody panel for this disease.

Led by Dr Naveen Vasudev and Professor Rosamonde Banks from the University of Leeds’ School of Medicine, Sengenics’ KREX proteomics technology will be used to discover tumour-associated autoantibodies that may have clinical utility as both diagnostic and therapeutic biomolecules. Serum samples will be screened using the Sengenics IMMUNOME protein array, a KREX-based array with more than 1600 full-length, correctly folded and functional proteins, including >200 known cancer testis and cancer-related antigens.

There were over 400,000 new cases of kidney cancer in 2018 with 650,000 new cases estimated to be diagnosed annually by 2040. RCC constitutes approximately 90–95% of all kidney neoplasms and 25–30% of all patients had metastatic disease upon its diagnosis. The early detection of renal cancer represents a major opportunity to improve outcomes as surgical removal or ablation while the tumour is still small and localised to the kidney offers 5 year survival rates in excess of 90%.

Speaking on the collaboration, Dr Vasudev and Professor Banks, co-leads of the Clinical and Biomedical Proteomics group at the University of Leeds based on the St James’s University Hospital campus and interfaced with the Leeds Teaching Hospitals NHS Trust said, “Autoantibody production is a key indicator of several diseases. As they may be detectable many years before disease manifestation, autoantibodies have the potential to be excellent biomarkers for early diagnosis of cancers. The Sengenics KREX technology is a powerful tool for characterising serological responses with exceptional specificity and sensitivity. Using the KREX technology, we will examine the presence and clinical utility of tumour-associated autoantibodies in RCC. We are looking forward to working closely with Sengenics in achieving our goal of developing an autoantibody-based diagnostic test for Renal Cancer.”

Professor Jonathan Blackburn, CSO of Sengenics, said, “Early detection of RCC remains a major clinical gap because current screening tools suffer from low specificity and sensitivity. We are excited to collaborate with the Leeds team and anticipate that use of Sengenics’ unique protein array technology will ultimately lead to improved diagnostic tests for RCC disease.”

About Sengenics

Sengenics is a functional proteomics company that leverages its patented KREX technology for production of full-length, correctly folded and functional proteins. KREX was invented and patented by Professor Jonathan Blackburn whilst he was a member of the faculty at the University of Cambridge.

The key application of KREX is the discovery of autoantibody biomarkers for two core medical use cases. Firstly, stratification of patients undergoing treatment with autoimmune or cancer drugs into responders, non-responders and those that may exhibit severe immune-related adverse events (irAEs). Secondly, identification of autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions years before conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

About University of Leeds

The University of Leeds is one of the largest higher education institutions in the UK, with more than 38,000 students from more than 150 different countries. The University is a member of the Russell Group of research-intensive universities and plays a significant role in the Turing, Rosalind Franklin and Royce Institutes.

The University is also a top ten university for research and impact power in the UK, according to the 2014 Research Excellence Framework, and is in the top 100 of the QS World University Rankings 2020.

Awarded a Gold rating by the Government’s Teaching Excellence Framework in 2017, the University of Leeds is recognised for its ‘consistently outstanding’ teaching and learning provision. Twenty-six of its academics have been awarded National Teaching Fellowships – more than any other institution in England, Northern Ireland and Wales.

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About Cancer Research UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit http://www.cancerresearchuk.org.

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Sengenics Partners with the Foundation for the National Institutes of Health Biomarkers Consortium

Sengenics, the functional proteomics company, today announced that it has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium. As a member of the consortium, Sengenics aims to further accelerate the identification and commercialisation of autoantibody biomarkers for early diagnosis of cancer and autoimmune diseases as well as development of new companion diagnostics tests.

The FNIH Biomarkers Consortium was co-founded by the U.S. National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Centers for Medicare & Medicaid Services (CMS) and BIO. It counts amongst its list of contributing members, major pharmaceutical companies such as Novartis, GSK and Merck; as well as not-for-profit organisations such as the Alzheimer’s Drug Discovery Foundation and the American Heart Association.

Sengenics will work with the FNIH Biomarkers Consortium to provide expertise about the discovery of autoantibodies for diagnostics, companion diagnostics and therapeutics applications, particularly through its proprietary KREX technology. As KREX-based protein arrays use antigens that are correctly folded and functional, autoantibodies are detected with very high specificity and sensitivity. The technology has already been applied to discover autoantibody biomarkers with both diagnostic and protective potential for cancers, autoimmune diseases and neurodegenerative disorders. KREX protein arrays have also been used for stratification of patients into responders, non-responders and those exhibiting immune-related adverse events (irAEs). This has been achieved with very high positive predictive values (PPV) and negative predictive values (NPV) for patients on autoimmune or immune checkpoint inhibitor drugs.

Joseph P. Menetski, Ph.D., Associate Vice President for Research Partnerships, FNIH said, “Autoantibodies are fundamental biomarkers for cancer and autoimmune disease diagnostics. We believe that Sengenics’ expertise will be complementary to the FNIH Biomarker Consortium’s key focus areas in terms of the rapid identification, development and qualification of potential high-impact biomarkers for improvements in drug development, clinical care and regulatory decision-making. We are looking forward to Sengenics making a positive contribution in terms of advancing medical diagnostics and research within the consortium.”

Speaking on the collaboration, Chief Scientific Officer of Sengenics, Jonathan Blackburn, D.Phil., said, “We are delighted to join the FNIH Biomarkers Consortium. We see this as an important vehicle to collaborate with industry experts and partners across the biomarker discovery and commercialisation chain. In the last year, we have seen our technology becoming established as the benchmark for high specificity and sensitivity autoantibody detection by both the pharmaceutical industry as well as leading academic institutions. Our fundamental aim going forward is to apply our technology to patient-centric, autoantibody-based, translational diagnostics tests for both precision medicine and early disease detection applications.”

About Sengenics

Sengenics is a functional proteomics company that leverages its patented KREX technology for production of full-length, correctly folded and functional proteins. KREX was invented and patented by Professor Jonathan Blackburn whilst he was a member of the faculty at the University of Cambridge.

The key application of KREX is the discovery of autoantibody biomarkers for two core medical use cases. Firstly, stratification of patients undergoing treatment with autoimmune or cancer drugs into responders, non-responders and those that may exhibit severe immune-related adverse events (irAEs). Secondly, identification of autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions years before conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit fnih.org.

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Sengenics Partners with Olivia Newton-John Cancer Research Institute to Enhance Safety of Cancer Immunotherapy Drugs

Sengenics, the functional proteomics company, today announced signing of a collaboration agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) focusing on profiling Immune-related Adverse Events (irAEs) using the patented Sengenics KREX™technology. The study will focus on Melanoma patients undergoing cancer immunotherapy using immune checkpoint inhibitor drugs and will be performed by Dr. Jessica Duarte in the Tumour Immunology Laboratory led by Dr. Andreas Behren.

Cancer immunotherapy has shown massive clinical potential but has been beset with safety concerns. In various clinical trials, up to 90% of patients show some grade of adverse reaction, with more than 30% of patients exhibiting serious grade 3 irAEs. Up to 2% of patients have life-threatening irAEs resulting in death. ONJCRI and Sengenics will leverage the KREX™technology which consists of microarrays of thousands of correctly folded and functionally verified proteins to discover autoantibody biomarkers in patients following administration of immunotherapy drugs. Discoveries based on the KREX™technology will then potentially be applied to stratify patients in terms of those that are at risk of developing high-grade irAEs.

Professor Jonathan Cebon, Medical Director of ONJCRI said, “Patients treated with checkpoint inhibitors often develop inflammatory reaction or irAEs as a result of immune system activation. The Sengenics KREX™ protein array technology has proven to be a very powerful tool for characterising serological responses of immunotherapy patients with exceptional specificity and sensitivity. We found that patients who developed clinically severe irAEs exhibited immune reactivity against a broad panel of autoantigens. The data generated from a small group of patients showed that patients experiencing high-grade irAEs could readily be distinguished on the basis of these autoantibodies. This technology may provide an early means for identifying patients at risk from developing severe irAEs during cancer immunotherapy.”

Speaking on the collaboration, Sengenics’ CSO, Professor Jonathan Blackburn said, “Collaborating with ONJCRI investigators with a 25-year track record of ground-breaking research into successfully integrating cutting-edge cancer science with deep clinical expertise has highlighted the potential of the KREX™ technology as an ideal platform for identifying cancer immunotherapy irAEs monitoring and toxicity prediction. Our ultimate aim is to work closely with ONJCRI to translate existing and future discoveries to improve the safety and efficacy of cancer immunotherapy drugs.”

Sengenics is currently involved in research collaborations encompassing 17 different cancers and has 5 patent applications involving the discovery of multiple autoantibody biomarkers for the early diagnosis, stratification and potential treatment of cancer. This year alone, the company has also started collaborations with high-level international institutions, including 8 of the top 10 global pharmaceutical companies and top tier universities such as Harvard, MIT and Stanford.

About Sengenics

Sengenics is a functional proteomics company that leverages its patented KREX™ technology for production of full-length, correctly folded and functional proteins. KREX™ was invented and patented by Professor Jonathan Blackburn whilst he was a member of the faculty at the University of Cambridge. Jonathan is the CSO of Sengenics.

The key application of KREX™ is the discovery of autoantibody biomarkers for two core medical use cases. Firstly, stratification of patients undergoing treatment with autoimmune or cancer drugs into responders, non-responders and those that may exhibit severe immune-related adverse events. Secondly, identification of autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions years before conventional diagnostic tests.

About Olivia Newton-John Cancer Research Institute

The Olivia Newton-John Cancer Research Institute (ONJCRI) is an independent medical research institute located in Heidelberg, Australia. ONJCRI’s mission is to discover and develop breakthrough therapies for cancers of the breast, bowel, lung, melanoma, prostate, liver, gastrointestinal and brain. Our researchers and clinicians are running more than 200 clinical trials, giving patients access to potential new treatments including immunotherapies and personalised medicine.