ProteinLogic Attends the 71st AACC Meeting

CAMBRIDGE, UK (2019-08-06) – ProteinLogic, the biomarker discovery and exploitation company, is attending the 71st annual scientific meeting & clinical lab Expo of the American Association of Clinical Chemistry (AACC).

 

Dr Nicolas Huber, CEO of ProteinLogic, commented: “The AACC meeting, with its exclusive focus on laboratory diagnostics, is the most prestigious meeting to be attending in the space. Our presence here creates new opportunities for ProteinLogic for strategic collaborations with established IVD manufacturers with an interest in our assets and platform technology. Further, it allows us to stay abreast of the current thinking and developments in the field of laboratory science.”

 

ProteinLogic Completes Multi-Site Clinical Study on TB, Reports Results Exceeding WHO Requirements

CAMBRIDGE, UK (2019-08-01) – ProteinLogic, the biomarker discovery and exploitation company, today announces the completion of its multi-site study on the use of its novel diagnostic technology, ImmiPrint®, for the ruling-out of Active Tuberculosis (TB) disease from a blood sample.

Previously, the company had shown that its ImmiPrint  technology could achieve the requisite clinical accuracy in a significant internal study of approximately 1000 clinical samples on laboratory-grade immunoassay platforms.

Under an EU Horizon 2020 grant (ADVANTAGE 666308), the company built on this work and commissioned clinical studies for the collection of further blood samples from subjects suspected of Active TB disease. Prospective samples were collected from TB clinics in Brazil, South Africa, Spain and the UK. The tested combined cohort from all sites comprised 1343 genetically diverse clinical samples.

ProteinLogic’s test exceeded the WHO-mandated clinical performance of 90% and 70% sensitivity and specificity respectively. In particular, sensitivity was 91%, specificity was 75%, and Negative Predictive Value (NPV), a key measure for a rule-out test, was 94%. Such results have not been reported to date from a blood test from cohorts of mixed backgrounds, as immunoassay approaches have traditionally been optimized on local populations and do not apply well to different genetic backgrounds. Importantly, these results were obtained from analysis of the samples on a new immunoassay measurement device that could potentially be used at the Point-Of-Care, proving that the ImmiPrint technology is transferrable across platforms.

Dr Nicolas Huber, CEO of ProteinLogic, commented: “The results from our latest, multi-site study prove conclusively that ProteinLogic has achieved a significant milestone, not only as complete clinical validation of its ImmiPrint technology in TB, a very difficult to diagnose disease, but also in the development of a diagnostic test with the ability to support the fight against this deadly disease. Having built evidence of the applicability of our novel approach across measurement platforms, we are confident we are entering the market with a diagnostic solution that is readily adoptable in settings where it is needed most, and are looking forward to expanding our technology to other indications”.

ProteinLogic is preparing publications of these results in peer-reviewed journals.

The company would like to thank the EU for the support of its work through the Horizon 2020 grant mechanism. The company would also like to thank its clinical collaborators across the globe for their support in this study.

ProteinLogic Appoints Dr Adrian Woolfson as Non-Executive Director

CAMBRIDGE, UK (2019-06-01) – ProteinLogic, the biomarker discovery and exploitation company, has appointed Dr Adrian Woolfson as Non-Executive Director.

Dr Woolfson is the founder of ProteinLogic, having discovered soluble Cluster of Differentiation antigens that underpin ProteinLogic’s platform technology.

He is currently serving as Executive Vice President of Research & Development, Sangamo Inc., CA, USA. Dr. Woolfson has over a decade of biopharmaceutical industry experience in drug discovery, medical affairs and early and late stage clinical development. Previously, he served as Chief Medical Officer at Nouscom AG, a genetic cancer vaccine biotechnology company based in Basel, Switzerland, where he led the development of the company’s off-the-shelf and personalized neoantigen vaccine and oncolytic virus strategy. Prior to Nouscom, Dr. Woolfson served as Global Clinical Leader, Early and Late Stage Immuno-Oncology/Hematology at Pfizer Inc. in New York, and was responsible for defining Pfizer’s hematology immuno-oncology strategy and building its immuno-oncology hematological malignancies portfolio. Prior to that he was the Global Lead for Pfizer’s SMO inhibitor glasdegib, which received FDA approval in 2018. From 2007 to 2013, Dr. Woolfson held roles of increasing responsibility at Bristol-Myers Squibb, including Global Medical Lead for a first-in-human CDC7 inhibitor and selective JAK2 inhibitor.

Dr. Woolfson completed his post-graduate training in internal medicine at Addenbrooke’s Hospital, Cambridge, UK. He holds a BM BCh degree in Clinical Medicine from Oxford University and completed his PhD in molecular immunology at Cambridge University. He was the Charles and Katherine Darwin Research Fellow at Darwin College Cambridge, and a Wellcome Trust Clinical Research Fellow. He completed his doctoral and post-doctoral work in the laboratory of Nobel Prize winner and inventor of monoclonal antibodies Dr César Milstein in the Division of Protein and Nucleic Acid Chemistry at the MRC Laboratory of Molecular Biology in Cambridge, UK.

Dr Nicolas Huber, CEO of ProteinLogic, said: “We are delighted to have Dr Woolfson, the founder of ProteinLogic, back on the company board. He is joining at a turning point for the company as we have entered a commercial phase with our first clinically validated asset for the diagnosis of Tuberculosis. His extensive expertise in the field will be crucial to guiding ProteinLogic through its first commercial endeavours. His vision will ensure that the long-term direction of the company is on a firm footing for growth, beyond Tuberculosis into other indications of significant medical need. We are excited to welcome him back on board”.

ProteinLogic has patent granted in USA and EU, files 2nd patent Company expands presence in the TB biomarker space

CAMBRIDGE, UK (2019-01-17)

ProteinLogic (PL), the biomarker discovery and exploitation company, has received approval for granting of its first patent in biomarkers for the diagnosis of Tuberculosis in the USA and the EU.

At the same time, the company has filed a 2nd patent in the same space. This new patent allows the company to expand the applicability of its unique biomarker signatures in the diagnosis of Tuberculosis (TB), while introducing further unique combinations of biomarkers that can provide accurate information for the diagnosis of the disease. This patent was critically informed by the results generated from the completion of screening of large cohorts of clinical samples sourced from clinical studies commissioned by ProteinLogic, and from a successful Freedom-to-Operate study performed by the company in June 2018.

With a granted patent, and another, expanded patent under review, ProteinLogic is now well positioned to enter the market in diagnostics for TB, disrupting the current standard-of-care, and making an impact in the fight against this terrible disease.

Further information:

info@proteinlogic.com

ProteinLogic Appoints Dr Edward Gibson as Non-Executive Director

CAMBRIDGE, UK (2018-09-01) – ProteinLogic, the biomarker discovery and exploitation company, has appointed Dr Edward Gibson as Non-Executive Director.

Dr Gibson holds a holds a degree in Chemistry from Bristol University, and a PhD in Biochemistry from Oxford University, where he also performed postdoctoral research. Since then, he has held a number of senior leadership roles with Bristol-Myers Squibb, focusing on commercialization and lifecycle management within the company’s oncology department, rising to becoming a member of the European oncology steering committee. He then went on to become Senior Director for New Product Strategy and EU commercialization with AVEO, as a member of the senior executive team. Since 2013, he has held the role of Global Pharma Key Opinion Leader for the Korean Health Industry Development Institute, and has devoted himself in the development of solutions to complex issues in healthcare access a CEO of an independent consultancy.

Dr Gibson commented: “Joining the board at this critical time in the development of ProteinLogic is an extremely exciting opportunity. I am looking forward to working with the diverse and knowledgeable team members in developing and delivering credible, commercial diagnostic solutions to complex disease problems. Starting with the acute need in identifying cases of Active Tuberculosis.”

Dr Nicolas Huber, CEO of ProteinLogic, commented: “I am very excited to welcome Dr Gibson to the board of ProteinLogic. He brings a wealth of knowledge in the biotech industry, including in markets in which ProteinLogic has keen interest. With his extensive expertise in the commercialization of novel products in the field, he will be instrumental in helping the company define the most direct and profitable routes to market for our unique Immiprint diagnostic for the ruling-out of Active Tuberculosis, maximizing the value of our solution. Dr Gibson’s  joining strengthens the board of the company with unique commercial know-how that is of paramount importance to our success. I am personally very much looking forward to closely collaborating with him in the near future.”

ProteinLogic Presents at McGill Summer Institute on Advanced TB Diagnostics

CAMBRIDGE, UK (2018-06-25) ProteinLogic (PL), the biomarker discovery and exploitation company, was invited to present its latest findings at the 8th McGill University’s Summer Institute for Advanced TB Diagnostics, held on the 18th-22nd of June 2018, in Montreal, Canada.

CEO Nicolas Huber presented PL’s exciting developments in TB diagnosis to participants from the global TB community, including members of the medical community, NGOs, epidemiologists, national TB program leaders, and industry experts. The results garnered significant interest for further implementation for collaboration and implementation of PL’s diagnostic in clinical practice, which avenues the company in now actively exploring.

Further information:

info@proteinlogic.com

ProteinLogic Joins BIVDA

CAMBRIDGE, UK (2018-06-06) – ProteinLogic the biomarker discovery and exploitation company has become an affiliate member of the British In Vitro Diagnostics Association (BIVDA). BIVDA is the national trade association for companies with major involvement and interest in the In Vitro Diagnostics (IVD) industry and has represented manufacturers and distributors of IVD products for over 25 years. Through BIVDA, ProteinLogic now has the opportunity to work with other members who share a common interest; participate and gain insight in many areas impacting the IVD industry such as regulatory updates and Brexit; be involved in championing the industry to politicians and policy makers; and help play a leading role in overcoming global health challenges such as Antimicrobial Resistance.

Further information:

info@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing novel diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The first product in the pipeline is a novel diagnostic blood test for tuberculosis. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in blood and other body fluids.

ProteinLogic Presents At Bio€quity 2018, Ghent, Belgium

CAMBRIDGE, UK (2018-05-17) – ProteinLogic attended 19th Bio€quity Europe event, held in Ghent, Belgium. Bio€quity Europe pioneered the turf-neutral concept, creating an open door for all members of the financial community and business development and licensing professionals to do business with independently selected presenting companies.

ProteinLogic was invited to present to a panel of investors and life-science professionals, garnering significant interest.

Further panel discussions of significant interest included topics on access to the Chinese market and investment, as well as the future of EU Biotech.

Further information:

info@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing novel diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The first product in the pipeline is a novel diagnostic blood test for tuberculosis. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in blood and other body fluids.

ProteinLogic At BioTrinity 2018, London, UK

CAMBRIDGE, UK (2018-04-26) – ProteinLogic attended BioTrinity 2018, Europe’s leading biopartnering and investment conference. During the event, ProteinLogic delegates took advantage of the partnering environment to provide exposure of our technology, and our validated TB diagnostic to investors and life-sciences key players.

The event included panel discussions of significant interest, especially regarding market access globally, the new life-science investment landscape, and alternative sources of funding.

Further information:

info@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing novel diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The first product in the pipeline is a novel diagnostic blood test for tuberculosis. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in blood and other body fluids.

ProteinLogic Appoints Darleen Welford as VP of Regulatory Affairs and Quality Assurance

CAMBRIDGE UK (2018- 03- 05) –  ProteinLogic, the biomarker discovery and exploitation company has
appointed Darleen Welford as VP of Regulatory Affairs and Quality Assurance (RA/QA) to bring
valuable global regulatory expertise, and to further the company’s RA strategy.

Darleen has over 19 years’ experience in the field of In Vitro Diagnostic Medical Devices and brings
with her a variety of regulatory and quality skills across the whole product life cycle, including
experience of global product registrations, risk management, quality management systems and
clinical study management.

Before joining ProteinLogic, Darleen worked in similar roles in the IVD sector, where she has gained
experience in both start-up and more established environments. Darleen has worked closely with a
number of regulatory authorities including the FDA and has attained ISO certification, GMP
certification and successful IVD registrations globally, including in the EU, Australia, Korea and Japan.

“I am very excited to be joining ProteinLogic at this important stage of the business” said Darleen. “I
am very much looking forward to working within the ProteinLogic team to accomplish the
commercialisation of our TB diagnostics, and making a significant impact in the field of diagnostic
medicine by further realising the full potential of the ProteinLogic proprietary technology
ImmiPrint®, in line with the commercial vison of the company.”

Nicolas Huber, ProteinLogic CEO, stated: “Darleen brings an extensive breadth and depth of
knowledge of the industry, as well as excellent knowledge of the regulatory landscape, which will
play a key role in the definition of our market-access strategy. In addition, moving into a more
commercial phase of the company, Darleen will ensure the high quality of our processes and our
products will make ProteinLogic a respectable player in IVDs. It is a pleasure to be welcoming
Darleen on board, and I am more than looking forward to be working with her moving forward.”

Further information:

info@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing novel diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The first product in the pipeline is a novel diagnostic blood test for tuberculosis. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in blood and other body fluids.