The Promarker™ Pipeline

Proteomics International’s Promarker™ Platform for protein biomarker discovery is a multi-step process. Grey lines in above image indicate the progress of a project since July 2020.

Biomarker discovery, verification and analytical validation is available as a fee for service model, or through a collaborative partnership with Proteomics International. Read more.

The Promarker™ Platform is currently being used to investigate the protein ‘fingerprints’  associated with the following diseases of unmet need:

 

Diabetic Kidney Disease

Status update: Commercialised

Three biomarkers for Diabetic Kidney Disease identified by the Promarker™ Platform have been verified, validated, and developed into a commercially available test: PromarkerD.

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Endometriosis

Status update: Proof of Concept study completed. Clinical studies pending.

In March 2020, Proteomics International announced it had identified and filed a patent application describing a panel of novel protein biomarkers with the potential to be developed into a simple blood test for endometriosis [ASX: 23 March].

Endometriosis occurs when the tissues that line the uterus spread outside of the uterine cavity and surround other organs. The debilitating disease affects one in nine Australian women, with the current gold standard for detection being a surgical procedure. Direct medical costs (outpatient and hospitalisation) associated with endometriosis in the United States surpass US$17.3 (A$29.3) billion annually.

Given the large unmet medical need and the only existing diagnostic tool being invasive surgery, Proteomics International believes there will be significant commercial interest in this program post successful clinical study validation.

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Parasite infections: Giardia

Status update: Proof of concept study completed. Validation study pending.

Proteomics International continues its development of an improved diagnostic test for the parasite Giardia in collaboration with the Murdoch University Veterinary School and a leading US veterinary company

Giardia is one of the most common parasitic human diseases globally. About 10% of those infected have no symptoms. In 2013, there were about 280 million people worldwide with symptomatic giardiasis. In some developing countries Giardia is present in 30% of the population, and in the USA it is estimated that it is present in 3-7% of the population.

The risk for human health is that some Giardia strains that affect pets can cross into humans (zoonotic), whilst others are host specific. Current tests cannot easily differentiate between the host specific and zoonotic strains.

Proteomics International has identified strain specific Giardia targets and developed a prototype immunoassay, which is pending validation using field samples. There is a large market opportunity for Proteomics International given that current tests have low accuracy and cannot easily be used to test if pets infected with Giardia present a risk to their owners.

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Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Status update: Ethics approved; Discovery study pending

Proteomics International has received ethics approval for a discovery study to identify biomarkers for asthma and chronic obstructive pulmonary disease, which cost health care systems tens of billions of dollars a year. The program was placed on hold whilst the company focused on PromarkerD clinical studies and other diagnostics projects, however, the discovery phase will commence shortly using the Promarker™ pipeline.

The study is in collaboration with the Busselton Population Medical Research Institute, which gives Proteomics International access to the globally-recognised Busselton Health Study, one of the longest running epidemiological research programs in the world.

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Plant Dieback (Phytophthora cinnamomi)

Status update: Discovery study ongoing.

The Company’s approach to developing diagnostic tests and identifying potential drug targets is not limited to human medicine. Proteomics International has an ongoing collaboration with the Centre for Crop and Disease Management, Curtin University to target the plant pathogen Phytophthora cinnamomi, which is responsible for plant dieback.

The pathogen has already infected more than 1 million hectares of Western Australian bushland, and also infects premium crops such avocados, macadamias and pineapples. Phytophthora attacks the roots of vegetation and inhibits them from being able to take up water and nutrients, resulting in death (termed Dieback). The estimated cost to the Australian economy is $160 million per year for damage to natural vegetation alone.

Current investigations are focused on proteomic analysis (determining the protein maps) of the life stages of the organism and how it infects its host. This has the potential to identify weaknesses in the pathogen that could be targeted to help eradicate this disease.

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Diabetic Retinopathy

Status update: Ethics approved. Discovery study pending.

Following the success of its diabetic kidney disease project, Proteomics International has signed a new collaboration agreement with The University of Western Australia to seek early markers for diabetic retinopathy.

Diabetes adversely affects the body’s blood vessels leading to a range of complications including heart (cardiovascular), kidney (nephropathy), nerve (neuropathy) and eye (retinopathy) damage. Currently a third of patients with diabetes have diabetic retinopathy – vision impairment caused by damage to blood vessels at the back of the eye.

Diabetic retinopathy is the major cause of blindness in the USA, responsible for approximately 20,000 new cases each year, but finding and treating diabetic retinopathy early can reduce the risk of blindness by 95%. An early diagnosis has the ability to transform quality of life outcomes, with commensurate billion dollar socioeconomic benefits.

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Markers for Oxidative Stress – ‘2-tag’ technology

Status update: Commercialisation discussion (Proof of concept study completed. Clinical validation pending).

Proteomics International has been in a long-term collaboration with The University of Western Australia to develop methodology that could become the next generation of medical diagnostic tests. The patented technology called “2-tag” measures the oxidative stress in a system [ASX: PIQ Prospectus 2015]. The Company’s intellectual property consists of granted patents in the USA (US 8,043,824 B2) and Australia (AU2006/001757) directed to a “Method to determine the redox {oxidation} state of proteins (‘2-tag’)”.

Every person has a base level of oxidative stress at all times – the human body requires oxidative stress to function. However, very high levels of oxidative stress can be dangerous and have been linked to a wide range of chronic diseases including stroke, heart attack, Parkinson’s disease, and muscular dystrophy and muscle damage.

The technology has now matured with the 2-tag test demonstrating proof of concept with several publications targeting Duchenne muscular dystrophy and new exploratory work in aquaculture and sports management. Proteomics International is currently examining commercial opportunities with The University of Western Australia to exploit this innovative technology

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Biomarkers for cancer

Status update: In-licensing discussion (Proof of concept study completed. Clinical validation pending).

Proteomics International is in discussion with a pre-eminent Australian medical research institute to in-license a novel mass spectrometry based cancer diagnostic test. The Company will provide further details as this develops.

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Novel disease biomarkers – ARC Centre for Personalised Therapeutics Technologies

Status update: In-licensing discussion (Ethics approved. Discovery study pending).

The Australian Research Council Centre for Personalised Therapeutics Technologies is a $3.1 million Federally funded Industrial Transformation Training Centre (ITTC) in which Proteomics International is working alongside leading university-based researchers to apply the Promarker™ technology to Complementary Diagnostics [ASX: PIQ Annual Report 2019].

Proteomics International is in advanced discussion with other consortium members for a discovery project in an area of significant unmet medical need. The Company will provide further details as this develops.

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COVID-19

Status update: Programs initiated.

Proteomics International has initiated COVID-19 research programs seeking to develop a rapid diagnostic test for the identification of the SARS-CoV-2 virus, and to isolate biomarkers that give insights into the progression of the COVID-19 disease.

These programs aim to build upon Proteomics International’s unique network of commercial and research partners and the Company’s experiences across diagnostics development, drug characterisation and biomarker discovery. The Company will provide further details as these programs develop.

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