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PDX Mouse Clinical Trials for Translational Cancer Research

Accelerate drug development with Crown Bioscience’s patient-derived xenograft (PDX) mouse models—designed for predictive insights and personalized oncology.

Enhancing Predictability: Advanced Translational Models

Oncology researchers frequently struggle with the poor predictability of standard cell lines and traditional xenografts, leading to high attrition rates in clinical trials because these models fail to accurately reflect human tumor biology and clinical response. To address this problem, Crown Bioscience's solution provides:
  • Clinically Relevant Models 
    We use patient-derived xenograft (PDX) and patient-derived organoid (PDO) models which retain the genetic and histological heterogeneity of the original human tumor.
  • Predictive Trial Design 
    Our Mouse Clinical Trial (MCT™) platform leverages large cohorts of PDX models to mimic human clinical trial design, providing statistically powerful, predictive data on drug efficacy and patient segmentation.
  • Translational Insight 
    By correlating preclinical data from these advanced models with human clinical outcomes, we offer a more reliable translational bridge, significantly de-risking your clinical development program and identifying potential responsive patient populations earlier.
PDX Mouse Clinical Trials: Bridging Preclinical and Clinical Oncology Research

PDX MCTs from Crown Bioscience provide a predictive, clinically relevant platform for oncology drug development. By preserving the genetic and phenotypic profile of the original human tumor, our PDX models enable researchers to bridge preclinical studies and clinical success—reducing attrition, accelerating biomarker discovery, and guiding more effective treatment strategies. 

Crown Bioscience's PDX MCTs, formerly known as HuTrial, are designed to bridge the gap between preclinical studies and clinical success, offering a reliable pathway to more accurate predictions and outcomes. Our services provide a comprehensive solution for drug developers seeking to optimize their pipelines, validate biomarkers, and reduce the risk of clinical attrition.

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Benefits of Patient-Derived Xenograft Mouse Clinical Trials

PDX MCT trials are used primarily to generate more predictive and clinically relevant data than traditional preclinical models. However, there are many other reasons to utilize this powerful assay, which:

Mimics Human Clinical Trials
Mimics Human Clinical Trials

PDX MCTs use a large panel of patient-derived xenograft models, each representing a unique patient's tumor. This design allows researchers to study a drug's effect across a diverse patient population, similar to a real-world clinical trial.

Identifies Responders and Non-Responders
Identifies Responders and Non-Responders

By testing a drug across a wide variety of PDX models, researchers can clearly distinguish between responding and non-responding tumors. This is crucial for developing personalized medicine strategies and defining the specific patient population that will benefit most from the treatment.

Predictive Biomarker Identification
Accelerates Biomarker Discovery

MCTs provide a powerful platform for identifying and validating predictive biomarkers. Researchers can analyze the genomic, proteomic, and spatial data from the responding and non-responding tumors to discover the molecular signatures that correlate with drug efficacy.

Offers Deeper Mechanistic Insights
Offers Deeper Mechanistic Insights

The comprehensive data generated from MCTs—including multiomics analysis, spatial biology, and advanced statistical modeling—provides a deeper understanding of a drug's mechanism of action (MoA) and potential resistance pathways.

Reduces Clinical Attrition & Cost
Reduces Clinical Attrition and Cost

The high failure rate of oncology drugs in clinical trials is often due to a lack of efficacy. By using PDX MCTs, researchers can generate robust preclinical data that more accurately predicts clinical outcomes.

Webinar

Mouse Clinical Trials: The Power Behind Study Design

Watch this webinar to learn about:

  • How the optimal number of PDX models and mice per PDX model can be determined to best suit your mouse clinical trial needs
  • How you can quantify and evaluate your drug’s efficacy
  • How study design is used to leverage biomarker discovery

Applications of PDX Mouse Clinical Trials in Oncology Drug Development

PDX MCTs are a versatile and powerful tool with numerous applications that accelerate the drug development process, such as:

Predictive Biomarker Discovery and Validation

Identify biomarkers that can be used to stratify patients, improving clinical trial success rates and supporting personalized medicine strategies.

Targeting Specific Patient Populations

Screen a drug across a wide range of PDX models to pinpoint the specific tumor types, genetic mutations, or disease subtypes where your therapy is most effective.

Exploring New Indications

Evaluate a drug's efficacy across multiple cancer types to uncover potential new therapeutic applications and expand treatment possibilities.

Drug Combination Strategies

Test drug combinations in a clinically relevant setting to identify synergistic effects and overcome resistance mechanisms.

De-Risking Clinical Trials

Generate robust preclinical data that can predict clinical outcomes, helping to justify the progression of a drug candidate to a human clinical trial and reducing the risk of costly failures.

WHITE PAPER

The Ultimate Guide to Mouse Clinical Trials

Unlock the potential of your oncology research with our comprehensive white paper. This essential resource is designed for researchers and professionals in the field of drug development.

Why Choose Crown Bioscience for
PDX Mouse Clinical Trials?

Integrated End-to-End Solutions

We offer a seamless workflow from trial design and model selection to final data analysis and reporting, ensuring consistency and quality at every stage.

Global Expertise

With decades of experience as a leading preclinical CRO, our global network of facilities and scientists provides a wide range of services with certified quality standards.

Validated Quality

We utilize our patented NGS-QC method to prevent model misidentification and contamination, ensuring the integrity and reliability of our models. All animal studies are conducted in AAALAC-accredited facilities under strict adherence to ethical guidelines.

Unparalleled Predictive Power

Our large, well-characterized PDX model library and advanced bioinformatics capabilities make our MCTs a highly predictive platform, helping to reduce the high attrition rates in clinical trials and accelerate drug development.

Searchable Database

Our PDX Model Database offers detailed characterization data, including RNA-seq (1,500+ models), whole exome sequencing (680+ models), growth kinetics, histology, and response to standard-of-care treatments.

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Crown Bioscience Features
Benefits
World's Largest PDX Model Library
Access to more than 2,500 models from diverse patient populations, ensuring high clinical relevance and accurate representation of tumor heterogeneity.
Advanced Statistical Analysis
We use Linear Mixed Model (LMM) analysis, which is more sensitive than traditional TGI, for optimized, data-driven trial designs.
Comprehensive Characterization
Every model is extensively profiled with multiomic data (e.g., RNA-seq, WES, histology, SoC response), allowing for precise model selection.
Integrated End-to-End Workflow
Seamless support from trial design to data analysis and reporting, ensuring consistency, quality, and efficiency.
Validated Quality Control
Our patented NGS-QC method prevents model misidentification, ensuring the integrity and reliability of our models.
Expert Bioinformatics Support
Our team provides consultation on study design, data analysis, and interpretation to deliver actionable insights.

Delivering Comprehensive Solutions in
PDX Mouse Clinical Trials

Our PDX Mouse Clinical Trials are designed to maximize the impact of your oncology research by offering:

  • Optimized clinical trial designs tailored to maximize predictive power and ensure clinical relevance, setting your studies up for success in oncology drug development.
  • Integrated data reports that combine biomarker discovery, PK/PD analysis, and bioinformatics to provide a holistic view of your study's outcomes.
  • Seamless service, from trial initiation to final report—our dedicated team ensures consistency, quality, and efficiency at every stage, empowering you to confidently advance in your drug development journey.

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Frequently Asked Questions

Can Crown Bioscience help select the best PDX models?

Absolutely! During the scoping phase, we provide complimentary support for study design and model selection, taking a data-driven approach to identify the ideal models. We leverage multiomics data—including genomics, transcriptomics, proteomics, and pathway activity—to find the best fit for your study.

How is the number of PDX models and animals determined for MCT?

For multi-PDX MCT studies, we use Linear Mixed Models (LMM) to generate power curves that estimate the number of models and animals based on drug potency. You can explore our published work for additional insights (Guo et al., BMC Cancer 2019).

For single PDX model studies, we apply our proprietary algorithm for sample size calculations. This tool uses historical standard-of-care (SOC) data to determine the necessary number of animals, considering metrics like Tumor Growth Inhibition (TGI) and the desired statistical power.

For more details or free access to our web-based sample size calculator, please contact us.

How are baseline factors balanced in group allocations for MCT?

Ensuring balanced group allocation is critical for reliable results. Randomization alone can lead to imbalances, so we use a proprietary algorithm that distributes baseline covariates—such as tumor size and body weight—equally across groups, minimizing bias in complex trials.

For more details or free access to this tool, please contact us.

How is drug efficacy analyzed in MCT?

To provide a comprehensive view of drug efficacy, we go beyond single time-point measurements by employing advanced metrics such as eGR (Exponential Growth Rate). This in-house metric analyzes the full tumor growth dataset, offering a holistic view of treatment impact. For more details, refer to our published work (Guo et al., BMC Cancer 2019).

What support is provided during MCT studies?

We support you throughout your MCT study, ensuring robust analysis and reliable results by focusing on:

  • Outlier Detection 
    Advanced methods are used to identify and address outliers, ensuring the data accurately reflects the treatment’s impact.
  • Design Optimization 
    Based on real-time data, we can recommend study adjustments to enhance quality, such as modifying model numbers.
  • Interim Reporting 
    Stay updated with real-time progress through interim reports available on our platform.
How are study results delivered?
Results are delivered in a traditional report format, and we also provide an interactive webpage, enabling you to explore the data dynamically in a user-friendly environment.

Contact Us