Case Study: Ichnos Glenmark Innovation optimizes first-in-human dosing with Certara QSP modeling

QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy

Ichnos Glenmark Innovation, a clinical-stage biotechnology company, faced the challenge of selecting a first-in-human dose for its tri-specific antibody cancer therapy, ISB 2001. A traditional, overly conservative approach risked prolonging the clinical trial timeline and costs by exposing initial patients to subtherapeutic dosing levels. The company engaged Certara and its Quantitative Systems Pharmacology (QSP) Center of Excellence to address this.

Certara developed a specialized QSP model using a Minimal Pharmacologically Active Dose (MPAD) approach. This model, which received regulatory approval from bodies like the US FDA, allowed for a starting dose 50-100 times higher than the traditional method. The solution optimized dose selection for Ichnos Glenmark, reducing the number of patients on subtherapeutic doses and streamlining the trial timeline and overall cost, accelerating the path to getting the treatment to patients.

Ichnos Glenmark Innovation

Mario Perro

Head of Biologics Research