Companion Diagnostics Tests

In pharmaceutical discovery an emphasis on the personalized medicine became a reality, and many new drugs start coming to market supported by tests that will help to make the decisions of who gets what drug, what’s the appropriate dose, and who’s in the greatest danger of serious side effects.

In recognition of the value of such tests, internal research and development at Ariadne-Dx is focused on the development of companion diagnostics (CDx) for cancer and neuromuscular/neurodegenerative disorders. Our approach is based on a better understanding of mechanism of biological processes and newly available data from testing at the molecular level to characterize patients and disease.

Colorector Cancer

Colorectal cancer (CRC) is the third most common cancer in both men and women. Each year, there are an estimated one million newly diagnosed cases of CRC worldwide and approximately half of the patients are developing metastases.

mCRC-strat™- Predictive screening test for mCRC

Ariadne-Dx is developing* CDx test for metastatic colorectal cancer (mCRC):

The mCRC-strat™ test is anticipated to be a semi quantitative immunohistochemistry (IHC) assay for the determination of biomarker panel expression in mCRC routinely processed for histological evaluation, however it is expected that the test may also incorporate genetic markers.

mCRC-start will predict the likelihood of an individual patient with mCRC to respond to the drugs Erbitux™ (cetuximab; Lily, BMS) and Vectibix™ (pantumimab; Amgen). Both of these drugs are monoclonal antibodies targeted at epidermal growth factor receptors (EGFR) which have been demonstrated to be up-regulated in CRC. Both drugs are already limited in use by the application of companion diagnostic tests to determine EGFR and KRAS expression status. Despite the use of these tests, only about 40% of patients who express EGFR and wild-type KRAS respond to these drugs. Thus, nevertheless the fact that EGFR is the direct target of these agents and KRAS is a key proximal downstream regulator of the EGF cellular pathway, it is clear that the efficacy of these drugs is dependent on a far more complex array of cellular mediators and that more extensive probing of these mediators is necessary to better predict drug efficacy.

Ariadne-DX is co-developing test together with BioMarCare (Israel).

Neuromuscular and neurodegenerative disease

Neuromuscular diseases (NMDs) form a diverse group of rare heterogeneous conditions which collectively affect between 6 and 8 million people worldwide. The most frequently occurring inherited forms of NMDs include Duchenne muscular dystrophy (DMD), spinal muscular atrophy (SMA), hereditary polyneuropathies (such as Charcot Marie Tooth disease) and myotonic dystrophy. There are currently no cures and few effective therapies for these diseases.

Novel therapeutic development in rare disorders including NMD and NDD is complicated not only because of the relatively low number of patients available for clinical trials but due to critical challenges regarding identification and development of sensitive and reliable outcome measures to adequately power smaller clinical trials. For these reasons, the identification of sensitive and reliable surrogate biomarkers becomes a high priority for facilitating the evaluation of emerging therapies in drug trials and regulatory approval in NMD and NDD. Thus, the use of biomarkers for the diagnosis, prognosis, and monitoring of NMD/NDD as well as to guide the choice of therapeutic regimens is predicted to be one of the leading priorities in clinical practice.

Ariadne-Dx is a member of two EU consortia (see our collaborators) that are working on to find the panel of surrogate biomarkers to monitor these diseases and also find the potential drug targets.

• Ariadne-Dx retains rights to develop and market diagnostic tests discovered together with its collaborators

– Prognostics

– Companion Diagnostics

– Disease Monitoring

The company expects to obtain certain regulatory advantages in the marketing of these tests due to the orphan status of these diseases.

Contract Research and Biomarker Program Support

The Company offers its services in biomarker candidate discovery and validation. Ariadne-Dx tailors its offerings for each client and services include biomarker discover, assay development, assay validation and clinical studies.