 Life Science Events, Jobs, Directory, News The past year marked a proverbial inflection point for organoid models designed to uncover biological insights previously unattainable through traditional cell culture experiments or animal models.
The FDA in October approved the first-ever investigational new drug (IND) submission supported solely through human vascularized organoid-based combination studies, without relying on traditional animal efficacy proof-of-concept (POC) testing. The IND application by SillaJen enabled the South Korea-based developer of oncolytic virus immunotherapeutics to begin clinical trials for a combination therapy consisting of tislelizumab or paclitaxel and BAL0891, a dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK).
SillaJen’s combo therapy incorporating BAL0891 is being evaluated in a Phase I trial (NCT05768932) whose primary completion date is estimated at December 24. SillaJen’s IND included preclinical efficacy data generated through the vascularized tumor immune microenvironment model (vTIME) developed by Qureator.
The vTIME platform and SillaJen’s trial are early examples of the shift…
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