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The preclinical evaluation of novel immunotherapies in terms of efficacy and safety remains a significant challenge, primarily due to the intricate nature of the human immune system itself and its altered functions in diseased states.

  • Existing nonclinical models are insufficient in capturing the complexity of the immune system and its intricate interactions with therapeutic interventions in both immune oncology and immune inflammatory diseases.
  • Current models may fail to detect toxicities associated with immunomodulatory drugs, as they heavily rely on animal models or utilize cells obtained from healthy donors.
  • If these models are species-dependent, overly simplistic, or incomplete, they only reflect limited aspects of the human immune system, disregarding the complexities of the diseased status and patient-specific characteristics. Such limitations can lead to inaccurate predictions of adversities in humans.