The immune system is a potent, flexible, and programmable ally in the fight against some of the most life-threatening clinical challenges. With the field’s current pace, immune-based therapy has become a mainstay of clinical practice, with results that were unimaginable a couple decades ago.
There is huge promise in harnessing the immune system, but misdirecting this powerful response can have serious and even life-threatening consequences for your patients. An understanding of the potential immunogenicity and immunotoxicity of your candidate/s is a regulatory requirement to support your first-in-human (FIH) program and an area where, unfortunately, “standard” in vivo toxicology assessments might lack relevance. As a result, the onus is on you, the biopharmaceutical developer, to ensure you have adequately assessed the possibility of your drug candidate/s to illicit an unwanted immune response.
In this webinar, we explore the challenges of assessing the immunosafety profile when moving a drug candidate to FIH studies. Our expert shares key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro immunotoxicity assessments add significant value by predicting risk early. This knowledge allows for modifications to the candidate or FIH package design to mitigate risk and increase the likelihood of a successful FIH study.