Navigate BioPharma Services, Inc. Launch Assay for Precise Measurement of Radioligand Therapy Response in Tumors

CARLSBAD, Calif., May 31, 2024 /PRNewswire/ -- Navigate BioPharma Services, Inc., a specialty laboratory offering high-quality, innovative precision medicine solutions and bioanalytics for clinical development and diagnostic applications, launch a new assay for quantifying pharmacodynamic markers of radioligand therapies in tumors. The development of this assay was presented in a poster entitled "Quantifying pharmacodynamic markers of radioligand therapies (RLTs) in tumor by multiplex immunofluorescence and automated quantitative analysis (AQUA) algorithms" at the American Association for Cancer Research (AACR) 2024 Annual Meeting held in San Diego, CA.

Navigate BioPharma Services' new image-based test measures the changes in the cancer cells and the tissue after RLT. This innovative assay utilizes multiplex immunofluorescence (mIF) combined with automated quantitative analysis (AQUA) algorithms to precisely measure changes in key protein markers within tumor tissues following radioligand therapy. For example, ionizing radiation produced by radioisotopes linked to antibodies causes double stranded breaks either directly or via generation of reactive oxygen species. This type of DNA damage is associated with an increase in markers for cell cycle arrest (e.g., p21/CIP1) and DNA repairing proteins (e.g., CHK2 and gH2Ax). Additionally, proliferating cells (identifiable by Ki67) are most susceptible to ionizing radiation as DNA is exposed during mitotic phase of cell cycle. These biologically verified markers are incorporated into a single multiplexed fluorescence immunohistochemistry (mFIHC) assay for robust quantitation of the pharmacodynamic activity of RLTs and to gain insights into DNA damage response and mechanism of efficacy from minimal tumor biopsy. This approach offers a comprehensive exploration of a therapy's impact on cell cycle and DNA damage within a tumor and tumor microenvironment.

"Radioligand therapies hold immense promise for targeted cancer treatment," said Jennifer Bordeaux, PhD, Associate Director of Digital Pathology at Navigate BioPharma Services. "Our new assay provides drug developers with a powerful tool to assess the therapeutic effects of these agents, ultimately accelerating drug development and improving patient outcomes."

The key advantages of Navigate BioPharma Services' assay include:

• Multiplex analysis: Enables simultaneous evaluation of multiple protein markers, providing a more holistic view of RLT's mechanisms of action.
• AQUA algorithms: Ensures robust and objective quantification of biomarker changes, reducing variability and improving data quality.
• Improved sensitivity: Detects subtle changes in protein levels, offering a more accurate assessment of therapeutic efficacy.

This assay underscores Navigate BioPharma Services' commitment to developing innovative solutions that empowers the biopharma industry to advance new therapies. The company's expertise in mIF, biomarker development, and other advanced analytical techniques positions them as a valuable partner for pharmaceutical and biotechnology companies developing novel radioligand therapies.

About Navigate BioPharma

Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development and companion diagnostic applications. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions.  The company has a proven track record of success in developing and validating assays for a wide range of therapeutic and diagnostic applications. Their extensive expertise offers high-quality, accurate, and reliable solutions for its customers and partners to make informed decisions about drug development and patient care. For more information about Navigate BioPharma's services, please visit www.navigatebp.com or connect with them on LinkedIn at www.linkedin.com/company/navigatebp/.

• Media and Customer Contact information: To incorporate this new assay or any other proprietary Navigate technology in an upcoming clinical trial study contact: Nick Sanna, Head of Business Development & Strategic Alliances, Navigate BioPharma Services, Inc. Phone: (760) 602-1409. Email: [email protected].

SOURCE Navigate BioPharma Services, Inc.