Certara announced the successful results of its partnership with Ichnos Glenmark Innovation (IGI) for the first-in-human dose prediction and selection of ISB 2001, a trispecific T-cell engager (TCE) intended for the treatment of multiple myeloma that has relapsed or is resistant. Leveraging Certara’s expertise in quantitative systems pharmacology and physiologically-based pharmacokinetics, the collaboration developed an innovative virtual clinical trial platform to optimize the FIH dose for ISB 2001. This approach addressed the traditional challenges of translating preclinical data to human patients, ensuring both patient safety and efficacy. The preclinical research and biosimulation findings, published in Nature Cancer, underscore the therapeutic potential of ISB 2001 for cancer patients.
The collaboration led to a significant increase in the clinical starting dose, by approximately 50-100 fold over conventional doses, minimizing the risk of ineffective dosing in cancer patients. This methodology has been accepted by both the U.S. FDA and Australian HREC, setting a new precedent for determining FIH dosing for TCEs. The virtual trial approach also proved to be time- and cost-efficient, aligning with regulatory goals to expedite drug development and reduce reliance on animal studies. Certara’s advanced biosimulation technology has accelerated ISB 2001’s path to patients, demonstrating the company’s commitment to transforming drug discovery and development across its global clientele of over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies in 66 countries.
