PrimePDX™: Next-Gen PDX for Clinical Simulation
Inquiry
Patient-derived xenografts (PDX) preserve tumor histology and heterogeneity in vivo, making them a critical bridge from in vitro studies to clinical translation. Building on this foundation, Alfa Cytology's PrimePDX™ combines a PBMC-humanized immune baseline with single-cell/small-aggregate initiation and early-passage use, plus optional human CAF microenvironment. The result is an integrated in vitro-to-in vivo workflow that accelerates confident decisions on candidate selection, combinations, and immune mechanisms.
Introduction to PrimePDX™ Platform
The PrimePDX™ establishes tumor PDX on a
PBMC-humanized immune background, bridging in vitro clinical simulation (
PDC/
3D) with in vivo studies to deliver immuno-oncology readouts that are closer to real-world settings. Methodologically, we use single-cell/small-aggregate initiation to improve starting uniformity and conduct efficacy in early passages to balance heterogeneity with statistical robustness; an optional human CAF xenograft increases stromal content and immune-suppressive features to emulate the "tumor fortress."
The platform is powered by a biobank of over 2,000 live tumor samples spanning major indication. It is integrated with a tumor database (pathology & multi-omics) and a patient database (clinical data & longitudinal follow-up), alongside GWAS/PheWAS, NGS, medical imaging, plasma/DNA/genotyped samples, and real-world data. This data backbone enables biomarker- and history-aware model selection, faster hypothesis testing, and a seamless in vitro-to-in vivo concordance workflow that strengthens decisions on candidate selection, dosing & scheduling, combinations, immune mechanisms, and patient stratification.
Advantages to PrimePDX™ Platform
Modeling
- Single-cell/small-aggregate inoculation improves starting uniformity and facilitates paired in vitro/in vivo mechanism testing.
- Efficacy in P2–P5 balances heterogeneity and clinical relevance with clearer group separation and stable statistics.
- Optional human CAF co-implantation heightens stromal content and immune suppression to better model antibody/cell-therapy challenges.
From In-Vitro to In-Vivo
- Use
PDC/
3D for high-throughput in-vitro stratification, then proceed to matched in vivo PDX; emphasize trend concordance and hit rate.
- Supports small molecules, antibodies/ADCs, checkpoint inhibitors, cell therapies, cancer vaccines, and oncolytic viruses.
Dual humanization
- Perform PDX efficacy and immune readouts on PBMC-humanized mice.
- Autologous pairing—same-patient PBMC × same-patient tumor in one mouse, is technically feasible and can be evaluated and custom-run subject to sample availability and ethics.
Comparison of Patient-Derived Xenograft (PDX) Model
The table compares conventional PDX, PDO, and PrimePDX™ across methodology, in vitro throughput, clinical simulation, in vivo efficacy, immune integration, and end-to-end application. Conventional PDX remains dependable for general in-vivo efficacy; PDO excels at high-throughput in-vitro screening. PrimePDX™ adds a PBMC-humanized baseline, single-cell/small-aggregate initiation, and early-passage (P2–P5) use, with optional human CAF to enhance stromal realism—delivering stronger from in vitro to in-vivo concordance, immune-relevant readouts, and a more time- and cost-efficient integrated workflow for immuno-oncology and translational decision-making.
|
PrimePDX™Model |
Traditional PDX Model |
PDO |
| Key Technical Aspects |
Patient-derived tumors are engrafted in mice to generate PDX models, followed by tissue dissociation and cryopreservation to create primary cell banks. |
PDX Fragment Biobank. |
Generation of a Biobanked Patient-Derived Organoid (PDO) Library. |
| In Vitro High-Throughput Analysis Capability |
Primary Cell Bank & High-Throughput Assays.
Strong In Vivo Data Correlation.
Cost-Competitive vs. Conventional Cell Lines. |
A key limitation is the absence of relevant in vitro models, creating a bottleneck for high-throughput screening. |
Suitable for high-throughput in vitro screening, albeit at a higher cost than primary cell-based assays. |
| Clinical Trial Simulation Capability |
Cost-effective, high-throughput clinical simulation studies, followed by verification in relevant small-scale animal models. |
Expenses and duration are multi-fold to ten-fold higher than in vitro high-throughput models. |
Suitable for in vitro clinical simulation studies, but lacks in vivo validation and is not sufficient for regulatory submission studies. |
| In Vivo Efficacy Testing Capability |
Superior Model Stability.
Enhanced Clinical Predictive Power. |
Poor quality control and model reproducibility
Loss of Clinical Relevance. |
No |
| In Vivo Model Efficacy |
Pre-Validation of Drug Efficacy in Candidate Models via In Vitro Screening.
>80% Concordance Between In Vivo and In Vitro Data. |
Inefficient Selection Strategy: Reliance on target profiling alone ignores key resistance pathways.
Major Project Delays: High rate of unresponsive models necessitates repeated in vivo studies, slowing progress. |
No |
| Degree of Humanized Immune System-Tumor Integration |
The vast majority of models can be established as dual-humanized and are suitable for drug efficacy testing. |
Poor compatibility with humanized immune system models. |
TME Modeling via Immune Co-Culture. |
| In Vitro, IND-Enabling, Clinical-Simulation Integrated Trilogy |
Universal Application: Suitable for both in vitro and in vivo studies.
Reutilization & Data Integration: A platform approach with a closed-loop data system.
Dramatic Cost Reduction: Cuts project costs to 1/2 - 1/3 of traditional PDX pathways. |
Solely For In Vivo Research |
Solely For In Vitro Research. |
Workflow for Generating a PDX Model in PBMC Humanized Mice
PBMC Humanization Modeling
- Isolate PBMCs, condition recipients, engraft and reconstitute.
- Proceed when human leukocyte reconstitution meets the project-defined threshold.
Tumor Processing
- Gently dissociate patient tumor to single-cell or small aggregates.
- Verify viability/phenotype and align with matched
in vitro models (
PDC/
3D).
PDX Engraftment
- Inoculate via Subcutaneous / Orthotopic / IV systemic / Brain.
- Optional human CAF co-implantation to boost stromal context.
- Enable IVIS if applicable.
Early-passage Expansion & QC
- Track P0→P2–P5.
- Confirm growth stability, histology/molecular retention, and group separation suitable for efficacy statistics.
Case Study
Case 1 PrimePDX™ -PDC (Patient-Derived Tumor Cell) In Vitro Efficacy Platform
- Model Introduction
This study evaluates the concordance of PDC-based in-vitro stratification for PD-L1 high NSCLC with in vivo efficacy on PBMC-humanized PrimePDX™. The aim is to test whether PDC results predict tumor response to immune checkpoint inhibitors (ICI) in the PD-L1 high, EGFR/ALK wild-type NSCLC model.
- Model Information
- Model: PrimePDX™ – NSCLC in PBMC-humanized mice
- Age：6–8 weeks
- Weight：18–22 g
- Passage：P2–P5 for efficacy
Model Characteristics
- Simulated Clinical Efficacy Testing
- Applicable for Small Molecule Drugs, Antibodies, Oncolytic Viruses, Immunotherapies, and Cancer Vaccines
- Cost-effective (Comparable to Tumor Cell Line Assays)
- Rapid Turnaround (<2 Weeks)
- High-throughput Cohort Screening
The in vitro and in vivo efficacy of the same model demonstrate high consistency
Case 2: PrimePDX™ -Next-Generation PDX Models with Enhanced Stability
- Model Introduction
This case study tests the efficacy of an ADCC-enabled antibody in PBMC-NK PrimePDX™ for HER2-positive breast cancer, focusing on dose optimization and immune response. The model evaluates immune-mediated efficacy and tumor infiltration dynamics, with in vivo readouts aligned to the ADCC mechanism.
- Model Information
- Model: PrimePDX™ – HER2-Positive Breast Cancer in PBMC-humanized mice
- Age：6–8 weeks
- Weight：18–22 g
- Passage：P2–P5 for efficacy
Model Characteristics
Stable tumor growth
- Tumor growth stability similar to CDX models.
- Allow usage of early passages.
Early passage for efficacy study
- Normally using P2-P5 for efficacy study.
- Early passages have a higher similarity to patient tumors.
Dual humanized models
- Stable PDX growth and PBMC reconstitution
- T, NK reconstitution.
Guaranteed High Success Rates
- Pre-screening with in vitro PDC models identifies optimal PDX models, ensuring a high success rate in subsequent in vivo efficacy studies
Superior Stability
- Demonstrates improved tumor growth stability and more significant intergroup differences for precise efficacy evaluation.
Preserved Clinical Relevance
- Utilizes early-passage PDX modeling to better retain the original tumor heterogeneity and drug response profile.
Streamlined Workflow Integration
- Enables efficient in vitro screening to select the most predictive models, boosting in vivo study success.
Why Choose Us
- Complies with the Standards of the Human Genetic Resources Regulations
- Comprehensive Patient Clinical Background
- Enhanced Usability & Stability: >50% vs. Conventional PDX Models
- Unique PBMC Compatibility: Enabling PBMC-PDX Dual-Humanized Models
FAQs
Do you support "same-patient PBMC × same-patient tumor in one mouse"?
It is research-feasible but limited by PBMC yield and patient condition. Our standard offering is PDX on PBMC-humanized mice; autologous designs require dedicated feasibility assessment.
How do you manage window and variability?
Via humanization subtype selection and SOP control with predefined dosing/observation windows, plus early-passage use and redundancy in readouts.
When is PrimePDX the best fit?
For immune-mechanism-centric programs—checkpoint, ADCC, NK modulation, bi/tri-specifics, cell therapies, vaccines—requiring integrated in vitro-to-in vivo evidence.
Leverage Alfa Cytology's PrimePDX™ Platform for reproducible, clinically relevant immuno-oncology readouts. From model provisioning and study design to dosing & monitoring, immune profiling, multi-omics/pathology, IVIS imaging, and statistical reporting, our expert team delivers standardized yet configurable workflows that align in-vitro findings with in-vivo evidence. Whether you're validating mechanisms, prioritizing candidates, optimizing combinations, or building biomarker packages, we help you move faster—and smarter.
Contact us to explore collaboration and request a custom study proposal
For research use only.
