RaDaR ctDNA liquid biopsy test to be used to monitor patient response in Phase 1/2 study of MVC-101 in multiple tumor types       

Research Triangle Park, NC, USA and Cambridge, UK, 29 October 2020 – Inivata, a leader in liquid biopsy, today announces a collaboration with Maverick Therapeutics (“Maverick”) for the use of Inivata’s RaDaR™ assay for the detection and monitoring of residual disease and recurrence. RaDaR will be used to monitor circulating tumor DNA (ctDNA) in patients enrolled in the Phase 1/2 study of MVC-101, Maverick’s lead program candidate.

MVC-101 is Maverick’s lead, conditionally active, T cell-engaging COBRA™ molecule designed to target Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. As prodrugs, COBRAs are engineered to take advantage of the tumor microenvironment for T cell activation, triggering T cell-mediated tumor killing specifically at the site of the tumor while sparing damage to the patients’ healthy tissues. EGFR is expressed on a wide range of solid tumors, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non-small cell lung cancers. Maverick expects to initiate a Phase 1/2, open label, dose escalation study of MVC-101 in Q1 2021.

RaDaR is a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity, allowing both detection of residual disease following curative intent or definitive treatment, and early detection of relapse. As part of the MVC-101 clinical study RaDaR will be used to monitor response in the trial participants following treatment with MVC-101. These data will provide valuable early insights into the effectiveness of this novel bispecific platform and help to inform both the proof of concept and recommended Phase 2 dose.

Peter Collins, Chief Business Officer of Inivata, commented: “The collaboration with Maverick is in line with our strategy to secure biopharma partnerships that utilize RaDaR in clinical trial settings to enable earlier insight on the efficacy of drug candidates for solid tumors. By providing valuable insight into a particular patient’s disease state, the assay has the potential to make clinical trials more focused and efficient.”

Jeremiah Degenhardt PhD, Vice President of Translational Oncology & Bioinformatics at Maverick Therapeutics, commented: “ctDNA has shown promise as a predictive marker of early response for immunotherapies in solid tumor indications. The patient-specific design of the RaDaR assay enables the detection of residual disease with exceptional sensitivity in multiple tumor types and it is therefore a highly complementary technology to advance our Phase 1/2 study. The use of RaDaR will enable our team to more accurately measure treatment success throughout the trial for our novel COBRA platform.”

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR™ assay – allowing the highly sensitive detection of residual disease and recurrence. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow Inivata on Twitter @Inivata.

About Maverick Therapeutics

Maverick Therapeutics is establishing itself as the leader in the race to apply T cell therapy to solid tumor cancers by focusing deep integrated expertise in drug development to design and deliver a pioneering immunotherapy platform. Maverick’s highly innovative COBRA™ therapeutic platform is the most mature, conditionally active bispecific T cell engaging platform designed to eliminate solid tumors. With COBRA, T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought after trifecta in cancer care; high specificity, high potency and reduced toxicity. Founded in 2016, Maverick is led by a team of leading experts in protein engineering and T cell therapeutic research and development. In early 2017, Maverick announced $125 million of committed funding from Takeda Pharmaceuticals (“Takeda”), MPM BioVentures 2014 and MPM Capital’s UBS Oncology Impact Fund. Based on the promise of the Company’s early-stage research, Maverick entered a five-year drug development project with Takeda. For further information, please visit www.mavericktx.com.