Certara & Ichnos Glenmark Innovation Collaboration Optimizes Dosing Strategy for Potential First-In-Class Cancer Drug

Core Insights - Certara, Inc. collaborated with Ichnos Glenmark Innovation (IGI) to optimize the first-in-human (FIH) dose for ISB 2001, a trispecific T-cell engager aimed at treating relapsed/refractory multiple myeloma, with results published in Nature Cancer [1][2] Group 1: Collaboration and Innovation - The collaboration focused on developing a virtual clinical trial platform using quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetics (PBPK) to enhance FIH dose selection [2][3] - The innovative approach allowed for a clinical starting dose increase of approximately 50-100 fold compared to conventional methods, reducing the risk of ineffective dosing for cancer patients [3][4] Group 2: Efficiency and Regulatory Alignment - Utilizing virtual trials for dose optimization not only saves time and costs but also aligns with regulatory goals, minimizing the need for animal studies in drug development [4][5] - The approach has been accepted by the U.S. FDA and Australian HREC, setting a precedent for determining FIH dosing for ISB 2001 and other T-cell engagers [3][4] Group 3: Company Background - Certara specializes in biosimulation software and services, serving over 2,400 clients in the biopharmaceutical sector across 66 countries, aiming to transform traditional drug discovery and development processes [6]