FDA Recommended Assays

Vivia Biotech is groundbreaking research in the field of T Cell Engager (TCE) through significant progress in ex vivo pharmacology studies for patients with hematologic malignancies

Vivia ex vivo TCE assays not only validate the scientific rationale behind bispecific antibodies but also offer insights into their potential efficacy and immunotoxicity, this approach follows FDA recommendations on bispecific antibodies development https://www.fda.gov/media/123313/download.
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Our ex vivo assays enable researchers to assess the efficacy and toxicity of ADCs in a patient-specific context, providing crucial insights into treatment response and aiding in the selection of optimal therapeutic strategies.
ImageADC
Our ex vivo assays enable researchers to assess the efficacy and toxicity of ADCs in a patient-specific context, providing crucial insights into treatment response and aiding in the selection of optimal therapeutic strategies.
Vivia Experience
FDA
Vivia Biotech offers comprehensive assays aligned with key FDA recommendations for TCEs development
  • Access to patient samples with hematological malignancies:
    • Fresh samples for multiple indications (AML, MM, CLL, NHL,…)
    • Large collection of frozen samples fully molecular characterized
    • Complete clinical data
  • Patented native environment assays, fostering a more physiologically relevant approach
  • Efficacy assays using flow cytometry:
    • Determination of the recommended first in human dose (FIH)
    • Perform different dual targeting strategies to show that blocking two targets yields additive or synergistic efficacy compared with a monospecific counterpart
    • Conduct cross-linking assays to show that simultaneous cross-linking of two receptors improve efficacy vs a monospecific product
    • Measure the target expression of your TCE revealing the interpatient variability
  • Evaluation of immunotoxicity:
    • Selective killing and hematotoxicity assays on tumor and normal bone marrow samples
    • CDC / ADCC assays to measure immunotoxicity potential by evaluating cytolytic processes through complement or antibody-depended interactions for cell lysis
    • Flow cytometric assessment of proliferation and activation markers to detect immune-mediated damage in nontarget cells
  • Cytokine release assays
  1. Tailored Assay Selection:
    We select the assay that best suits your ADC payload, whether it involves assessing depletion or proliferation dynamics. Our tailored approach ensures that the assay aligns optimally with the specific characteristics of your compound, leading to more accurate and insightful results.
Tailored Assay Selection For ADC Compounds
  1. Tailored Assay Selection:
    We select the assay that best suits your ADC payload, whether it involves assessing depletion or proliferation dynamics. Our tailored approach ensures that the assay aligns optimally with the specific characteristics of your compound, leading to more accurate and insightful results.
Tailored Assay Selection For ADC Compounds
Toxicity Analysis For ADC Compounds
  1. Off-Target Toxicity Analysis:
    Our comprehensive approach includes analyzing toxicity not only in target cells but also in off-target populations or even in normal bone marrow (NBM) cells. This thorough assessment provides valuable insights into the safety profile of your ADC.
  1. Off-Target Toxicity Analysis:
    Our comprehensive approach includes analyzing toxicity not only in target cells but also in off-target populations or even in normal bone marrow (NBM) cells. This thorough assessment provides valuable insights into the safety profile of your ADC.
Toxicity Analysis For ADC Compounds
  1. Internalization-Activity Correlation:
    We investigate the correlation between internalization and killing efficacy. We explore the impact of both competitive or non-competitive monoclonal antibodies (MAb) that compete or not with your ADC target, as well as ADCs conjugated with pH-sensitive probes. Our approach facilitates an understanding of how internalization dynamics influence the overall therapeutic effectiveness of your ADC.
Internalization Activity Correlation
  1. Internalization-Activity Correlation:
    We investigate the correlation between internalization and killing efficacy. We explore the impact of both competitive or non-competitive monoclonal antibodies (MAb) that compete or not with your ADC target, as well as ADCs conjugated with pH-sensitive probes. Our approach facilitates an understanding of how internalization dynamics influence the overall therapeutic effectiveness of your ADC.
Internalization Activity Correlation
Target Expression Activity Correlation
  1. Target Expression-Activity Correlation:
    We measure the cell surface expression of diverse markers across various pathologies using the mean Receptor Density (RD). Through the assessment of ADCs activity via the AUC, we unveil the correlation between cell surface expression (RD) and activity (AUC). This provides valuable insights into the mechanisms driving your ADC efficacy.
  1. Target Expression-Activity Correlation:
    We measure the cell surface expression of diverse markers across various pathologies using the mean Receptor Density (RD). Through the assessment of ADCs activity via the AUC, we unveil the correlation between cell surface expression (RD) and activity (AUC). This provides valuable insights into the mechanisms driving your ADC efficacy.
Target Expression Activity Correlation
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