Wednesday April 14, 2021 0 comments
WESTMINSTER and CAMBRIDGE, Mass. -- Flagship Biosciences, a leader in data-centric pathology and tissue analysis, and Massachusetts-based Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced a partnership to use a clinically validated tumor expression assay utilizing RNAscope® and tissue image analysis.
In a poster shared this week at the American Association for Cancer Research (AACR) Annual Meeting 2021, the companies presented data on the validation of a Dickkopf-1 (DKK1) RNAscope chromogenic in situ hybridization (CISH) assay and digital image analysis solution.
DKK1 is a secreted modulator of Wnt signaling that is frequently overexpressed in tumors and associated with a poor prognosis for patients. DKN-01 is a humanized monoclonal therapeutic antibody that binds to and blocks the activity of DKK1 and has demonstrated clinical activity in gastric/gastroesophageal junction (G/GEJ) adenocarcinoma patients with elevated tumoral expression of DKK1 RNA.
The companies have demonstrated that the DKK1 RNAscope assay and accompanying digital image analysis solution is specific, sensitive, accurate and reproducible according to Clinical Laboratory Improvement Amendments (CLIA) guidelines.
The assay is currently being applied to prospectively identify G/GEJ patients with elevated tumoral expression of DKK1 for treatment with a DKN-01 plus tislelizumab combination (Leap Therapeutics; NCT04363801).
"CISH assays can be used for the interrogation of clinical samples when protein targets are not sufficient," said Flagship Biosciences CEO Trevor Johnson.
"However, reading these assays can be challenging for pathologists. At Flagship, our pathologist-driven image analysis generates unique cellular data profiles that allow for the kind of robust quantitative solution that Leap was looking for.
“Using our proprietary image analysis technology and patented, cell-based tissue analysis, we deliver the data-rich tissue interpretations to support therapeutic development."
"This is a robust laboratory developed test (LDT) that is superior to traditional DKK1 immunohistochemistry (IHC) by demonstrating improved specificity and sensitivity," said Michael Kagey, senior director of Translational Medicine.
"Furthermore, the use of the digital image analysis algorithm to quantify DKK1 signal and support pathologist interpretation is a novel approach that reduces the risk of scoring bias."
To select patients for their clinical study, Leap Therapeutics sends samples from the United States and the Republic of Korea to Flagship's centralized laboratory. Flagship conducts the RNAscope assay, image analysis, data analysis, and in-house pathologist review, providing the information needed to make clinical trial enrollment decisions.
"The DKK1 RNAscope LDT is an integral component of our clinical development strategy," said Douglas E. Onsi, president and CEO of Leap Therapeutics.
"The rapid sample turnaround time from Flagship has allowed for the prospective screening of patients to support enrollment. We look forward to our continued partnership with Flagship."