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.

ProteinLogic Appoints Dr Nicolas Huber as Chief Executive Officer

CAMBRIDGE, UK (2018-02-19) – ProteinLogic, the biomarker discovery company, has appointed Dr Nicolas Huber as its Chief Executive Officer.

Dr Huber holds a Masters degree in electronic engineering and a PhD in Space Science from the University of Sussex. After working in the aerospace sector he transitioned to the biomedical sciences, and over the past 8 years has been focused on medical device research and commercialization. Most recently he has developed a new portfolio of devices for the treatment of cancer, and built a product development team and new business line within an established multinational. Dr Huber during this time has also been working with several start-ups in the healthcare sector as a mentor, and providing them guidance on market access and positioning.

“This is a very exciting time to be joining ProteinLogic”, Nicolas commented. “Recent positive developments with the Tuberculosis (TB) diagnostic signature demonstrate that there is a robust and compelling opportunity to realise the medical and commercial vision of the Company. The potential of ProteinLogic’s proprietary immune profiling technology, ImmiPrint®, for the early detection and diagnosis of human diseases is significant.

The most recent analysis and independent validation of multiple samples from a large prospective cohort of TB patients shows that we have achieved, and indeed exceeded, the WHO’s Target Product Profile specifications for a TB rule-out test. This has considerable commercial potential, and the potential to address a healthcare issue of profound global medical significance. The latest data has provided a definitive validation of the Company’s core platform technology, and promises to be the first of many future successes.

My focus as the incoming CEO will be on four key areas, namely: strengthening the Company’s foundations, building a winning team, defining and executing a coherent growth strategy, and ensuring the Company’s long-term financial sustainability.

I am excited to be working with the Board of Directors on making progress on these, and growing ProteinLogic to become a prominent player in the thriving Biotechnology space.”

Mr Peter Klimt, acting Chairman of ProteinLogic, stated: “We are delighted to have Nicolas on-board. His experience in commercialising new medical devices, his understanding of the broader healthcare landscape, and his energy and personality are an excellent addition to ProteinLogic just as the company is entering a phase of intense focus on commercialisation of our proprietary technology. The Board and I are looking forward to working closely with Nicolas to deliver commercial success for our unique diagnostic solutions.”

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.

48th Union World Conference on Lung Health in Guadalajara, Mexico

ProteinLogic attended the 48th Union World Conference on Lung Health held in Guadalajara, Mexico, held on 11th-14th October 2017.  The conference theme was  ‘Accelerating Toward Elimination’.

There was a focus on how to accelerate toward elimination of Tuberculosis. Numerous prominent scientists and global thought leaders emphasised the need for pro-active steps to find people with Active TB and the importance of blood based rule-out triage test for Active TB.

Delegates from more than 100 countries attended the four-day scientific programme of plenaries, symposia and abstracts presented by experts from around the world. The conference saw debate and discussion from public health professionals, researchers, scientists, civil society and the community.

Further information:

Mahesh Shah, ProteinLogic Ltd,

mahesh.shah@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing a novel diagnostic platform and diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose and predict 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 the blood and other body fluids.

In addition to the TB diagnostic test there are a number of potential follow-on products in the Company’s pipeline.

www.proteinlogic.com

ProteinLogic develops a Rule-Out Test for Active TB

CAMBRIDGE, UK (2017-08-30) – ProteinLogic, a biomarker discovery company, funded by a grant by the European Union Horizon 2020 SME programme to develop a rapid point-of-care test for the diagnosis of Active Tuberculosis (TB), has achieved a significant milestone.

In 2015, 10.4 million people fell ill with TB and 1.8 million died from the disease. Over 95% of TB deaths occur in low and middle-income countries. Whilst TB incidence has fallen by an average of 1.5% per year since 2000, there is an urgent need to accelerate this to a 4–5% annual decline. The World Health Organisation has set a 2035 target of 95% reduction in deaths and a 90% decline in TB incidence – similar to current levels in low TB incidence countries today. To achieve this the WHO has called for the accelerated development of new tools for the diagnosis of TB. A panel of international experts on TB agreed that highest on their list of priorities was the development of a rule out test that can be used by first-contact health-care providers to identify those who need further testing (the triage test). Such a rule out test can also be used as a systematic screening test for active case-finding.

A rule out test for active TB has significant potential impact on TB transmission. By enabling the early identification of those symptomatic patients who do not have TB, healthcare professionals can focus on the smaller numbers who test positive to investigate further to diagnose and treat those with Active TB. Each person with Active TB can potentially spread the disease to many others thus feeding the cycle of transmission of the disease.

The ProteinLogic TB test comprises a unique panel of biomarker proteins tested on over 1600 clinical samples from S.Africa, Uganda, Vietnam, Peru and London. In a recent study analysing 500+ high quality clinical samples, ProteinLogic scientists have achieved a level of accuracy (measured by sensitivity, specificity, negative predictive value and positive predictive value) comfortably exceeding the WHO criteria for a rule out test.

Dr Alexander Betz, Chief Scientific Officer of ProteinLogic, commented “ProteinLogic has taken great care to use state of the art statistics and validation methodology and analysed the largest sample set to date exceeding anything published in the literature. In this latest study using over 500 well characterised prospective TB samples, we obtained results that meet and in fact exceed the target product profile for a rule out test set by the WHO. Whilst we need to do further validation studies to independently verify this, we are cautiously optimistic.”

 

ProteinLogic’s Chairman Mahesh Shah said: “We are excited by the results. This would not have been possible without the help and support of the European Commission in funding this exciting project. We would also like to thank FIND (Foundation for Innovate Diagnostics) who provided clinical samples and invaluable support. This is a significant step forward in the global fight to eradicate TB.”

The estimated market size for a Rule-Out Test for Active TB is estimated to be 80million tests per annum. Whilst India, China, South Africa and Indonesia represent almost 50% of the global market, there is also a sizeable market in Europe, US and Latin America with a market potential of over 5million tests per annum. The market potential varies according to the penetration of the test into decentralized settings and the patient populations or types of TB it detects. The ProteinLogic Test has also got the potential of being useful for the more difficult cases of extra-pulmonary TB and also Childhood TB.

Further information:

Mahesh Shah, ProteinLogic Ltd,

mahesh.shah@proteinlogic.com

ProteinLogic

ProteinLogic is a biomarker discovery and exploitation company developing a novel diagnostic platform and diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose and predict 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 the blood and other body fluids.

In addition to the TB diagnostic test there are a number of potential follow-on products in the Company’s pipeline.

www.proteinlogic.com

Horizon 2020

Horizon 2020 is the financial instrument of the European Union, implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe’s global competitiveness. Horizon 2020 is the biggest ever EU research and innovation program. Through the SME Instrument, the European Union wants to finance the most innovative small companies with a high growth potential. The program promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market.

By coupling research and innovation, Horizon 2020 is helping to drive economic growth with its emphasis on excellent science, industrial leadership and tackling societal challenges. The goal is to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together in delivering innovation.

Selected SMEs, showing a strong ambition to develop, grow and internationalise, shall be supported across Horizon 2020 with a dedicated instrument to provide staged and seamless support covering the whole innovation cycle.

For more information please visit http://cordis.europa.eu/programme/rcn/664237_en.html