Alan Schafer our new CTO discusses the potential of personalized liquid biopsy in clinical trial development and recruitment
The potential of personalized liquid biopsy in clinical trial development and recruitment
Throughout much of my working career I have focused on genetic and molecular diagnostics, making the move to Inivata as Chief Technology Officer a logical choice and a very rewarding experience. What is highly compelling, and clear to me, is that Inivata’s innovative and pioneering technology offers the potential to transform cancer treatment and thus transform the lives of cancer patients.
In cancer care, there is a strong need to assess the ongoing impact of a specific treatment and consequently guide the therapeutic actions by specifically and sensitively tracking the status of an individual patient’s unique tumor. Inivata is well positioned to meet this need with its RaDaR assay, a personalized tool for the detection of minimal residual disease (MRD) and recurrence.
Personalized, highly sensitive assay
The RaDaR assay is an innovative liquid biopsy technology in several ways. Built on Inivata’s proven InVision liquid biopsy platform technology, RaDaR has been developed to track up to 48 tumor-specific variants in a patient from a blood sample, regardless of tumor type. With exceptional sensitivity, it can be used in multiple cancers for detection of MRD as well as for early detection of recurrence. This provides valuable insights into a patient’s disease state which may influence the clinician’s recommended treatment path.
When detecting MRD and recurrence, sensitivity is a key factor for effective liquid biopsy technologies. Higher sensitivity should allow earlier detection and potentially earlier action directed at recurrence or residual tumor. RaDaR’s tumor DNA detection sensitivity of 97% and specificity of 100% at 20 parts per million (equivalent to 0.002%) was demonstrated in data recently presented at AACR 2020. Such exceptional sensitivity resulting from the assay’s innovative design enabled the detection of circulating tumour DNA (ctDNA) up to a year ahead of clinical progression in early-stage non-small cell lung cancer (NSCLC) patients. These features demonstrate the critical information that RaDaR can provide, and by extension, reinforce its applicability to biopharmaceutical companies within their clinical trials for development of cancer therapies.
Significant impact on drug development and clinical trials
A good example of RaDaR’s use by a biopharma company is the recently announced collaboration with Maverick Therapeutics. Using the RaDaR technology, levels of ctDNA will be monitored in patients enrolled in Maverick’s Phase 1/2 study of MVC-101, its lead program candidate, in solid tumor indications. Data from the assay will be used to monitor participants’ responses following treatment with MVC-101, thereby providing valuable early insights into the effectiveness of the drug candidate, and helping inform both the proof of concept and recommended Phase 2 dose. The opportunities for biopharma companies to use RaDaR in clinical trial settings to enable earlier insight into the efficacy of drug candidates for solid tumors, and to make the trials more focused and efficient, are vast. We have been delighted by the high level of interest expressed to date by potential biopharma partners.
In addition to providing early visibility of drug efficacy, RaDaR also has huge potential for use in guiding patient selection to enrich clinical trial populations. The use of RaDaR can increase recruitment rates by identifying a broader range of treatment candidates than is possible with current technologies.
I have been most fortunate to join Inivata at a great stage in its development and look forward to progressing its technology to drive forward the company’s strategy. But even more so I am eager to support and enable RaDaR’s wider application and to help demonstrate its clinical value and positive impact on cancer treatment and patients lives.