Neomed Labs Pacific Biomarkers PAIRimmune are now Nexelis
 

Immuno-Oncology

Immuno-oncology (IO) expertise at Nexelis is founded on our immense depth of experience in assay development. IO encompasses a great deal, but at its heart is an immune response. Immunogencity is a Nexelis core competency.

In immuno-oncology, Nexelis continues to expand our service offering. Preclinical and clinical exploratory solutions are available globally, supported by teams with decades of experience to provide scientific and technical solutions using a multi-platform approach to support your clinical investigation in oncology.

With our flexible and custom programs, we stay at the cutting edge of scientific excellence in IO. Nexelis brings speed and improved decision-making to your development program. Similarly, your scientific and project management points of contact remain consistent for the project duration. We commit to providing exceptional service to improve the success of your program.

Case Studies

EXAMPLE ONE

An IO customer approached our Early Development scientists in Gosselies, Belgium, following lead candidate selection. This client was interested in determining functionality and potency of their chosen compound.  ImmunXperts, a Nexelis company, developed various in vitro bioassays to mimic the tumor environment. 

The bioassay we designed screened the functionality of new IO candidates. Dependent on the target of the candidate, specific immune cells are used such as T cells, myeloid cells (macrophages), natural killer (NK) cells, and other immune cells. The immune cells are conditioned to mimic the phenotype of the immune cell within the tumor environment like exhausted T cells, regulatory T cells (Tregs), and M2 macrophages. Our various models monitor their behavior (functioning) in the presence of test compounds.

Recently, in support of personalized medicine therapeutics, ImmunXperts designed in vitro models to monitor the neoepitope-specific immune response. The personalized therapy targets specific mutations in the tumor of the patient. The team developed an assay that consists of an optimized enrichment protocol to allow detection of low frequent T cells in the PBMC samples using fluorospot or cell sorting to measure the antigen-specific immune response. The assay results allow monitoring of the strength and breadth of the immune response in the presence of their therapy.

EXAMPLE TWO

A client approached our CAP/CLIA-certified laboratory in Seattle, Washington, to execute a technology transfer to achieve validation for a novel bispecific antibody. The biomarker assay was ELISA-based utilizing mesoscale discovery (MSD) to measure B-cell activating factor, a ligand within the tumor necrosis factor in human sera. 

The technology transfer and validation followed a defined quality-controlled protocol and measured sensitivity, precision, and recovery efficiency. The scientists preserved long-term stability of the assay and reagents, a critical step for consistent assay performance. The validation success not only met the critical timeline but also met regulatory and industry acceptance criteria. Following the validation, this assay was utilized to test clinical trial samples to support several Phase I clinical trials. 

The Nexelis team successfully executed the technology transfer, meeting both the scientific data output and timeline the client required. Our team optimized the assay to test clinical trial samples in batches to ensure sample throughput met required report delivery timing and to minimize variability between batches.

Our Oncology Credentials

  • Experience with a wide range of therapeutics
  • Small and large molecules including monoclonal antibodies, mRNA, bispecific antibodies, peptides and cell therapy
  • Support for discovery, preclinical, and clinical testing
  • Premier biological assay laboratory supporting:
    • Cell-based assays
    • Flow cytometry
    • Ligand binding assays
    • Molecular assays
    • Chromatographic assays

Oncology: Discovery to Clinical

Immunotherapies, Gene and Cell Therapies, Vaccines

  • Epitope prediction
  • MHC-Associated Peptide Proteomics assay (MAPPS)
  • Primary cell functional assay (e.g., macrophage polarization, T‑cell exhaustion killing assays)
  • Immunogenicity
    • Humoral, cellular, and innate immune response
  • Preclinical efficacy
    • Humanized models
    • Tumorgenicity models
    • Immuno-oncology models
    • T-cell exhaustion models
  • Customized qPCR
  • Biodistribution and shedding
  • T-cell response using ELISpot
  • Cytokines and chemokines using MSD or Luminex
  • Customized assays within our immune monitoring services
  • Biostatistical analysis of exploratory clinical data

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Nexelis can help you in the advancement of your project.

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