Lymphoma patients are monitored during treatment to determine whether the lymphoma is responding or is refractory to treatment, and for several years after treatment to determine whether the lymphoma is relapsing. Monitoring is performed using general health checks and positron emission tomography/computed tomography (PET/CT) imaging to measure vital tumor tissue. However, use of PET/CT imaging is limited by its cost, the radiation it exposes patients to and its low positive predictive value (meaning that a positive test, may not correlate with disease burden). This delays detection of refractory or relapsing lymphoma and subsequent decisions on treatment by clinicians, negatively impacting outcomes for patients and raising costs for health care systems. Interviews with clinicians and pharma execs have confirmed that there is an unmet need for a simple, accurate and cost effective test to monitor lymphoma.
To address this, ExBiome BV is developing its proprietary ExmiR technology platform, which enables detection of cancer from a simple blood sample (so-called “liquid biopsy”). The ExmiR technology identifies and measures RNAs which are modified in disease and released into the blood in organelles called extracellular vesicles (EV). ExBiome has reached proof of principle with its ExmiR(Lymph) test, which measures EV-bound RNA markers that correlate with disease burden in lymphoma patients. The test comprises of a simple EV purification and RNA detection kit, that can be used on standard equipment found in diagnostic laboratories. It is being developed for use by clinicians and drug developers to:
- Prognose treatment outcome early and support decisions on treatment and
- Monitor patients for relapse of disease, to enable early treatment with improved outcomes.
There are two markets for the ExmiR(Lymph) test: the pharmaceutical clinical trials market (estimated at €90m for lymphomas) and the hospital market (estimated at €450m for lymphomas), with no competitive products on the market. ExBiome is targeting these markets sequentially because a relatively simple technical validation will enable the ExmiR(Lymph) test to be sold as an ancillary test in pharma clinical trials, while longer term clinical validation and registration are required to enter the in vitro diagnostic hospital market.
Importantly, the ExmiR platform is highly differentiated and scalable. The modifications in EV-bound RNAs which it detects, appear to be tied to the cellular dysregulation that characterises all cancers. This differentiates it from DNA-based liquid biopsy tests that are in development for a number of cancers, because these focus only on the minority of cancers identified with highly prevalent “DNA-driver mutations” (DNA driver mutations are genetic alterations that may drive a particular cancer). Consequently, ExBiome will focus on the many cancers such as lymphoma and multiple myeloma, which lack common DNA-driver mutations, ensuring that the ExmiR platform can readily gain competitive advantage and can be scaled in the future.