A Dutch company offers a new way of looking at Alzheimer’s development by applying (epi-)genetics-based knowledge to factors that epidemiologically and/or experimentally have been linked to Alzheimer's development. For project second phase, the company is looking for a partner experienced in biosensor/like technology to develop a simple inexpensive device for screening, diagnosis and efficacy follow-up during drug development, within the frame of a joint venture or a license agreement.
The Dutch SME has a mission to improve human health and safety by detecting pathology triggered by environmental factors and lifestyle before it turns into disease.
The company transfers (epi-)genetic test methods for toxicity into fast, cheap, and minimally invasive preclinical diagnostics for three high impact pathologies (neurodegeneration, cancer, and immune-dysfunction) triggered by environmental factors and lifestyle.
The problem: Lack of tools that can identify individuals at risk for developing Alzheimer’s disease (AD) before significant brain damage has occurred results in a 99.6% failure rate for therapeutics development efforts.
Researchers focussed on direct causes of brain damage and symptoms looking downstream through the keyhole of mild cognitive impairment to understand initiation and early development of the disease. They applied animal models representing familiar (early onset) AD (<5%) and not sporadic (late onset) AD (>95%), and do not develop human pathology. A lack of understanding of the early events and early diagnostics has resulted in the current diagnostic strategy, which is performed late in AD development, takes weeks to months, includes painful interventions with risk for the patient, and has a low accuracy (<60%).
The opportunity: The market for AD diagnostics and therapeutics is looking for new approaches, while patients and healthcare workers demand a fast, non-invasive, and accurate test.
The company offers a new way of looking at AD development by applying human relevant (epi-)genetics-based knowledge, acquired by exposing established methods for toxicity testing to environmental factors that epidemiologically and/or experimentally have been linked to AD development. Subsequently, the in vitro outcome is evaluated against human peripheral clinical and control samples.
The Solution: A medical device for non-invasive diagnosis of prodromal AD.
By incorporating a minimal set of circulating biomarkers into a simple and cheap diagnostic device AD diagnosis becomes possible with reduced invasiveness and with focus on initiation and early development of AD, thus allowing for identification of patients before brain damage. The impact of such a device will be tangible at the level of screening and diagnosis (first line medical care) and in preclinical and clinical phases of therapeutics development.
Market Focus: Diagnostics, Contract Research Organizations (CROs), Biotech and Pharma
The primary markets for the diagnostic test include Diagnostics, Pharma and Biotech companies, as well as CROs that are active in the field of neurodegeneration in general, and AD in particular. The envisaged earning models include test performance by the company at a competitive price (CRO), license fees and royalties, and the sale of biomarker kits and devices.
Expected Returns: Driven by the status of the diagnostics tool.
The first milestone for returns is the availability of an evaluated diagnostic test (anticipated by end 2023) ready for full validation in collaboration with a commercial partner.
For the second phase of the project (2022 – 2023) the company is looking for a partner (preferentially a Biotech company) experienced in biosensor, biosensor/like or equivalent innovative technology to develop an algorithm and to incorporate the biomarker profile and algorithm into a simple inexpensive device for screening, diagnosis and efficacy follow-up during drug development.
Returns are expected to further increase during the validation process due to industrial application. Full validation (anticipated by 2025) and approval by the regulatory authorities (anticipated by 2028) will trigger broad application, followed by further increase of returns.
Cooperation is envisaged within a joint venture agreement or a license agreement.
- Type of partner sought: Experienced in biosensor, biosensor/like or equivalent innovative technology, micro-ribonucleic acid (microRNA) detection and specific algorithm development.
- Specific area of activity of the partner: Partner type: (preferentially Biotech company) experienced in biosensor, biosensor/like or equivalent innovative technology allowing for detection of a microRNA profile in human blood, plasma or serum for diagnosis based on a specific algorithm.
The partner is expected to develop a biosensor, biosensor/like or equivalent allowing for detection of a microRNA profile at levels of pico tot femtogram’s per millilitre in human blood, plasma or serum for diagnosis based on a specific algorithm.
Certification standards (ISO 13485) and compliance with Directive 98/79/EU under the Commission Implementing Decision (EU) 2020/439 are requested
Concept stage - A shortlist of peripheral biomarkers (N=65) with diagnostic value in a variety of cohorts of asymptomatic patients with memory deficits (Mini-Mental State Examination (MMSE) >17), when compared to age/gender matched control individuals (MMSE >27), is available and ready for (phase 1) evaluation in larger populations to confirm the validity of the biomarkers and to define a minimal biomarker profile (N<20). A TR for phase 1 is published as POD-profile TRNL20201015001. Phase 2: to develop an algorithm and to incorporate the profile and the algorithm into a simple inexpensive device for screening, diagnosis, and efficacy follow-up during drug development.