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Immune Checkpoint Bioassays Power Combination Immunotherapy

Richard is a Strategic Collaborations Manager focusing on building strategic relationships with biotech and pharmaceutical customers through technical introductions on early access technologies, custom assay services, and collaborative support. Prior to Promega, Dr. Somberg worked at Life Technologies where he led product development and service efforts in biochemical and cell-based assays for key target classes in drug discovery. He received his PhD in immunology from Purdue University and completed post-doctoral studies at the University of Pennsylvania.
  • Richard Somberg, PhD

  • Strategic Collaborations Manager

  • Original Webinar Date: Tuesday, September 27, 2016

Therapeutic antibodies designed to block or activate immune checkpoint receptors are a powerful new approach to the treatment of cancer and other diseases. However, due to their biologic complexity the development of therapeutic antibodies requires unique functional and analytical tools. Here we present a suite of MOA-based functional bioassays for use in antibody screening, characterization, potency testing and stability studies.

Immunotherapy strategies designed to induce, strengthen or engineer a patient's own immune system have emerged as powerful new approaches for the treatment of cancer and other diseases. Among the most promising approaches is the development of therapeutic agents that modulate the complex network of immune checkpoint receptors, which in turn regulate immune responses. These include antibodies designed to:

  • Block co-inhibitory receptors (e.g. PD-1, CTLA-4, LAG-3 TIGIT)
  • Activate co-stimulatory receptors (e.g. GITR, 4-1BB, OX40, CD40)
  • Modulate a combination of receptor signals to achieve a more robust immune response

The discovery and development of therapeutic antibodies is critically dependent on the availability of mechanism of action (MOA)-based and quantitative functional bioassays. Current methods used to measure the activity of antibody and other biologics drugs designed to target immune checkpoint receptors rely on primary human cells and measure functional endpoints such as laborious and highly variable due to reliance on donor primary cells, complex assay protocols and unqualified assay reagents. As a result, these assays are difficult to establish in quality-controlled drug development settings.

To overcome these challenges, we developed a suite of cell-based bioluminescent reporter bioassays for individual or combination immune checkpoint immunotherapy targets. Our MOA-based bioassays are available in "thaw-and-use" format and demonstrate high specificity, sensitivity and reproducibility. The bioassays are qualified according to ICH guidelines and demonstrate the performance required for use in antibody screening, characterization, potency testing and stability studies.