
Case Study · Mechanistic
ADC Platform
Challenge
The development of antibody-drug conjugates (ADCs) is fraught with challenges, including dose-limiting toxicities, nonspecific distribution to healthy tissues, and poor tumor penetration. Traditional approaches, such as in vitro assays and in vivo models, often fail to account for the complexities of ADC behavior in humans, leading to resource-intensive, time-consuming, and unreliable predictions of clinical efficacy and safety.
Our Solution
Our ADC Quantitative Systems Pharmacology (QSP) platform provides a robust and predictive solution by leveraging preclinical data to model clinical outcomes. The platform informs first-in-human dosing, optimizes therapeutic regimens, and predicts potential adverse effects, such as neutropenia and thrombocytopenia. Calibrated and validated with well-established ADCs like T-DM1 and T-DXd, it is adaptable to any ADC, offering a rigorous, scientifically grounded framework for development and regulatory submissions.
Outcome
Our QSP platform provides accurate, data-driven predictions that reduce the reliance on resource-intensive experimental methods. This approach accelerates development timelines, enhances safety assessments, and enables the creation of more effective therapies.
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Summary
Discovery
- Identify the best target combinations for a bispecific ADC
- Estimate the best affinity, avidity properties for antibodies
- Choose between multiple leads & select best payloads
- Predict FIH and Efficacious doses
- Support Investigational INDs, NDAs, BLAs, IBs, & BBs
Development
- Dose justification: RP2D, RP3D and pediatric populations
- Label recommendations
- Bridging recommendations to regulatory agencies
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