Espicom View: This agreement highlights the expansion of companion diagnostic development into further fields than oncology. Espicom has noted the beginning of companion diagnostics use in neurology, and now the trend for personalised medicine is becoming apparent in the autoimmune arena. As the focus on biomarkers increases and the use of companion diagnostics to expedite development times becomes more common, we are likely to see increasing numbers of companion diagnostic agreements in other therapy areas.
Can-Fite BioPharma has signed an agreement with Smart Assays to develop a commercial biomarker blood test kit for the A 3 adenosine receptor (A 3AR). Can-Fite's A 3AR predictive biomarker kit is designed for use at any molecular biology laboratory prior to treatment to help identify an individual patient's responsiveness to the company's drugs, thus providing personalised medicine.
Can-Fite's proprietary drugs target and bind to A 3AR, causing cancer and inflammatory cell apoptosis. This creates a targeted anticancer and anti-inflammatory effect, while leaving normal cells unharmed. The US PTO recently issued Can-Fite a patent for the utilisation of A 3AR as a biomarker to predict patient response to its drug, CF101, in autoimmune inflammatory indications.
In a Phase IIa rheumatoid arthritis (RA) study, it was found that 70% of patients had high A 3AR baseline levels. These patients were the most responsive to CF101, an A 3AR agonist. In December 2013, Can-Fite reported favourable results from a Phase IIb RA trial for CF101. Only patients with elevated baseline expression levels of the biomarker A 3AR were enrolled in the study. CF101 met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA.
CF101 is in Phase II/III trials for the treatment of psoriasis and Can-Fite is preparing for a Phase III CF101 trial for RA as well as a Phase II trial for osteoarthritis. Can-Fite's liver cancer drug, CF102, is in Phase II trials and has been granted orphan drug designation by the FDA. CF102 has also shown proof of concept to potentially treat other cancers, including colon, prostate and melanoma.
Personalised Medicine Market
Personalised medicine is fast becoming an attractive field, with the benefits already being seen in oncology. Companion diagnostics are quickly being utilised to guide a drug's development and secure regulatory approval. In some cases, a deal to bring a companion diagnostic into development at an early stage has even expedited development, allowing developers to utilise the FDA's Fast Track or Priority Review approval pathways.
As the success of companion diagnostics grows in the oncology field, we are seeing an increasing number of agreements in other therapy areas. In the neurology arena, as targeted drugs are being developed for treatment of Alzheimer's disease, Parkinson's disease and dementia, among other neurology disorders, the uptake of companion diagnostics is increasing.
The use of companion diagnostics is now entering the autoimmunology field. In January 2013, QIAGEN made a strategic equity investment in Drug Response Dx, with the option to obtain worldwide rights to biomarkers for evaluation of RA patients to guide treatment with TNF-alpha inhibitors, which are widely prescribed for treatment of RA. Companion diagnostics are rare in the RA market, and Can-Fite will be one of many that are developing a targeted approach to the treatment of RA. It is likely that further companion diagnostic partnerships will occur biomarkers that play a role in the disease are discovered.