Advanced Cell Diagnostics, Inc. (ACD) a company that provides a sensitive and specific RNA hybridization technology, recently announced that Merrimack Pharmaceutical is utilizing their leading technology to choose participants for a new Phase 2 clinical study to test the efficacy of the company’s drug candidate MM-121.
ACD’s RNA scope technology will be used to select patients that have heregulin positive, advanced or metastatic non-small cell lung cancer (NSCLC). This new trial is the first in which Merrimack’s will evaluate MM-121 only in patients with a high heregulin biomarker profile. MM-121 was previously examined in other Phase 2 studies where it showed effective benefits when combined with other traditional therapies.
“Our selection of the RNAscope-based heregulin test for this clinical trial is the culmination of multiple clinical studies in which we evaluated RNAscope. These trials have repeatedly demonstrated the potential of heregulin as a promising biomarker in predicting the therapeutic benefits of MM-121,” stated Gavin MacBeath, Senior Vice President of Translational Research at Merrimack in a recent press release. “We believe that the high sensitivity and specificity that RNAscope provides are necessary to identify the patients most likely to benefit from MM-121 in this Phase 2 clinical trial. RNAscope’s ability to detect heregulin within the confines of tumor cells, compatibility with existing automation instruments and with small tissue specimens such as fine needle aspirates and core needle biopsies were all important considerations in our decision to work with ACD.”
“We are delighted that Merrimack has selected RNAscope as the biomarker platform for their MM-121 clinical program. This marks the first of many examples of RNAscope’s adoption to support the development of companion diagnostic tools for pharma and biotech companies. We believe that RNAscope’s robust capabilities and open platform make it an ideal foundation on which to develop highly capable CDx solutions that maximize trial efficiency by enabling drug developers to more effectively zero-in on those patients most likely to benefit,” added Dr. Yuling Luo, Founder, President and CEO of ACD, in a news release.
RNAscope Technology is a novel in situ hybridization (ISH) assay for detection of target RNA within intact cells. The assay represents a major advance in RNA ISH approaches with its proprietary probe design to amplify target-specific signals but not background noise from non-specific hybridization.