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Case Study

Systems Modeling Delivers Efficiencies and Savings in Clinical Development

Discover how an IO-focused company developing immunotherapies applied QSP modeling solutions for cost-effective clinical development.

CDR-Life is a biotechnology company developing T-cell engagers (TCE) across a broad range of targets and solid cancers. The company is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC).

Therapeutic specialty

Oncology

"A crucial factor for us in choosing Applied BioMath as our partner was their expertise, flexibility, and clear communication of how our preclinical data can support the QSP approach. That was a key part of our decision. We appreciate their dedication in helping meet our timelines.”
Melissa Vrohlings, Translational Science Leader at CDR-Life

Overcoming Challenges Using Expert Solutions

CDR-Life sought to establish the initial dosage for human trials and identify the therapeutic dose range using data from their preclinical studies.

Challenge

A key objective for CDR-Life was to select an appropriate first-in-human starting dose that would be high enough to potentially demonstrate efficacy, minimizing the need for extensive dose escalation cohorts before reaching the efficacious dose range.

Solution

Applied BioMath* developed a QSP model based on preclinical data and knowledge of human disease. This model was used to support the starting dose selection which led to a higher starting dose than determined using a traditional MABEL approach and was approved by regulatory agencies.

“The QSP modeling and clinical pharmacology package you used to support our program was instrumental to the success of our study. The deep expertise and patience you brought to the program were game-changing as we now have a state-of-the-art development program for a T cell engager. The QSP-derived starting dose enabled us to start at a higher dose in the clinical trial and we are pleased to report that this starting dose was accepted for the IND and CTA for our lead T cell engager, CDR404. We look forward to updating the QSP model with real patient data as well as maintaining the ongoing collaboration with Applied BioMath.”
Swethajit Biswas, Chief Medical Officer at CDR-Life

Impact

Thought-Leadership

Applied BioMath provided subject matter expertise and provided the rationale for the QSP approach, supporting the client’s overall development and dose justification for their IND submission.

Responsiveness to Client’s Needs

Applied BioMath’s team exhibited the flexibility to accommodate the client’s requests and meet CDR-Life’s tight timelines. This allowed the client to explore their questions throughout the project

Cost and Time Savings in the Clinic

Our innovative approach using QSP modeling allowed CDR-Life to start trials with a higher starting dose, which resulted in the need for fewer patients in trials, shortened the trial duration, and provided cost savings in their clinical development stages.

Development Driven by Forward Thinking

On a strategic level, the incorporation of QSP approaches to CDR-Life’s development program underscored its innovation and cutting-edge technologies to help accelerate the drug development process.

 

“The QSP modeling and clinical pharmacology package you used to support our program was instrumental to the success of our study. The deep expertise and patience you brought to the program were game-changing as we now have a state-of-the-art development program for a T cell engager. The QSP-derived starting dose enabled us to start at a higher dose in the clinical trial and we are pleased to report that this starting dose was accepted for the IND and CTA for our lead T cell engager, CDR404. We look forward to updating the QSP model with real patient data as well as maintaining the ongoing collaboration with Applied BioMath.”
Fei Hua, VP, Modeling and Simulation Services

*Applied BioMath was acquired by Certara in Dec 2023

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