Biomarker-selected clinical trial supported by RNA detection technology

Merrimack Pharmaceuticals is utilising RNAscope technology, from Advanced Cell Diagnostics (ACD), to select patients for its Phase 2 clinical trial of its product candidate MM-121. The technology enables robust single RNA molecule detection in routine formalin-fixed, paraffin-embedded (FFPE) clinical specimens.

In previous Phase 2 clinical trials, RNAscope has been used to detect the mRNA of heregulin, a ligand for the drug target of MM-121. MM-121 is a fully human monoclonal antibody that targets the HER3 receptor, which has been identified as a critical tumourigenic node in several types of cancer.

Gavin MacBeath, senior vice president of translational research at Merrimack, noted that multiple clinical studies have “repeatedly demonstrated the potential of heregulin as a promising biomarker in predicting the therapeutic benefits of MM-121”. As such, the latest trial will solely include cancer patients with a high heregulin biomarker profile, as determined by RNAscope.

“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,” MacBeath said. “RNAscope’s ability to detect heregulin within the confines of tumour cells, compatibility with existing automation instruments and [compatibility] with small tissue specimens, such as fine needle aspirates and core needle biopsies, were all important considerations in our decision to work with ACD.”

Dr Yuling Luo, the founder, president and CEO of ACD, said the company is “delighted that Merrimack has selected RNAscope as the biomarker platform for their MM-121 clinical program”.

“We believe that RNAscope’s robust capabilities and open platform make it an ideal foundation on which to develop highly capable CDx solutions that maximise trial efficiency by enabling drug developers to more effectively zero in on those patients most likely to benefit,” he said.