Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, and Flagship Biosciences , the leader in data-centric pathology and tissue analysis, today announced that they have developed an image analysis RNAscope ® assay that is being used successfully
CAMBRIDGE, Mass. and WESTMINSTER, Colo., May 12, 2021 /PRNewswire/ -- Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, and Flagship Biosciences, Inc., the leader in data-centric pathology and tissue analysis, today announced that they have developed an image analysis RNAscope® assay that is being used successfully for prospective patient enrollment in a clinical trial. To the companies' knowledge, this is the first example of an RNAscope assay using a digital image analysis solution for patient enrollment. The findings were published in an article, "Validation of a DKK1 RNAscope chromogenic in situ hybridization assay for gastric and gastroesophageal junction adenocarcinoma tumors," on Monday, May 10 in Scientific Reports. It can be viewed at https://rdcu.be/ckjl5. Co-authored by a collaborative team from Leap Therapeutics, Flagship Biosciences, and Athenaeum Pathology Consulting, the article highlights how Leap is identifying patients likely to benefit from DKN-01, its anti-Dickkopf-1 (DKK1) antibody, and Flagship's ability to validate and implement complex biomarker assays using digital image analysis. Leap and Flagship's work centered on the development and validation of a 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. Leap and Flagship have validated the DKK1 RNAscope assay and accompanying digital image analysis solution as specific, sensitive, accurate, and reproducible according to Clinical Laboratory Improvement Amendments (CLIA) guidelines, and their work 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). Additionally, the companies are using the DKK1 RNAscope assay and digital image analysis solution for a retrospective analysis of G/GEJ patients treated with DKN-01 in combination with tislelizumab and chemotherapy. Biomarkers are increasingly prominent in drug development and are often applied in clinical trial design to determine the patients who are most likely to benefit from a specific therapeutic or treatment regimen. To use a biomarker strategy to prospectively identify patients, the biomarker test must be robust and precise. Because of the challenges in manual semi-quantification of RNAscope tissue staining, Leap and Flagship developed the novel digital image analysis algorithm that identifies tumor cells and quantifies DKK1 signal. "A potential challenge with RNAscope is manual scoring, which requires a pathologist to score the tissue at a high magnification to visualize and count the number of stained dots that appear in tumor cells," said Michael Kagey, Ph.D., Senior Director of Translational Medicine at Leap Therapeutics. "Since this can lead to slow, inaccurate, and non-reproducible scoring, we worked with Flagship to develop a digital algorithm. The digital algorithm reduces pathologist time, potential variability from manual scoring and allows us to reliably screen for patients who may benefit from our therapy." In addition to the prospective screening of patients, the work is also further advancing the companion diagnostic development of the RNAscope assay and could generally be used as a guide for the validation of RNAscope CISH assays with digital image quantification. "Our technology, combined with our scientific process and pathology oversight allows you to quickly find the right patients and get to your endpoints more rapidly," said Trevor Johnson, CEO of Flagship Biosciences. "Image analysis also provides a superior return on investment by saving time and helping get drugs to market more quickly. Our ability to take a completely novel pathology approach and turn it into a CLIA-validated diagnostic test to help our clients is extremely gratifying." "Our clinical development has been enhanced by the rapid, prospective patient screening that has happened as a result of using the DKK1 RNAscope CISH assay and digital image analysis solution," said Douglas E. Onsi, President and CEO of Leap Therapeutics. "As a result of the partnership between Leap and Flagship, the patients who we believe will best benefit from our drug are now being included in our trial. We look forward to further collaborating with Flagship Biosciences." About Leap Therapeutics RNAscope® is a registered trademark of Advanced Cell Diagnostics, Inc., Newark, CA, USA. FORWARD-LOOKING STATEMENTS About Flagship Biosciences For more information please contact: For Leap Therapeutics: Heather Savelle Media Contact for Leap Therapeutics: For Flagship Biosciences:
SOURCE Leap Therapeutics, Inc. |
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Company Codes: NASDAQ-NMS:LPTX |