Certara shared the results from its collaboration with Ichnos Glenmark Innovation, IGI, on the first-in-human dose prediction and selection for ISB 2001. IGI’s drug candidate is a trispecific T-cell engager, TCE, being studied as a potential cancer treatment. Preclinical research and biosimulation findings were recently published in Nature Cancer. This publication highlighted ISB 2001’s therapeutic potential for relapsed/refractory multiple myeloma patients. As a result of this collaboration, the clinical starting dose increased by approximately 50-100 fold over the conventional starting dose. Using this higher dose reduces the likelihood of exposing cancer patients to ineffective doses. Accepted by the U.S. FDA and Australian HREC, this approach paves the way for determining FIH dosing for ISB 2001 and other TCEs.
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