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Efficacy Studies

Validated Efficacy Models for Oncology, Immunology & Metabolism

Efficacy Studies

Establishing a rational design for in vivo efficacy study requires validated mechanisms of action (MOA) and qualified models for high-resolution lead screening. At WuXi Biologics, our in vivo efficacy services focus on lead screening and dosage optimization, utilizing comprehensive oncology models such as syngeneic and CDX/PBMC models, specializing in bispecific T-cell engager (TCE) and antibody-drug conjugate (ADC) efficacy studies. For autoimmune & metabolic diseases, we have developed over 30 validated models, covering a wide range of clinical symptoms. These efficacy models are continuously updated to incorporate cutting-edge humanized platforms, offering tailored solutions to meet custom preclinical studies.

 

Key Features of Efficacy Services:

  • Diverse oncology (syngeneic, CDX/PBMC, IVIS/Orthotropic) and autoimmune & metabolic disease models
  • Rationale design for potent donor screening, T cell infiltration and IHC-validated target validation
  • Tailored to meet preclinical needs with expert support for troubleshooting and data interpretation

 

Autoimmune and Metabolic Disease Animal Models

 

Efficacy Service Details:

Service Item

Description

Turnaround Time

 

 

 

 

 

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Efficacy Study

Sample requirements:

1.     Protein amount: BW (mouse/25 g) × animal numbers × 150%

2.     Protein purity: >98%

3.     Endotoxin level: <2 EU/mg

4.     Protein concentration (mg/mL): > dosing level (mg/kg)/10 (mL/kg)

 

Deliverables:

1.     Tumor growth inhibition (TGI%) or index of disease symptoms

2.     Body weight and clinical observations

3.     IHC results for T cell infiltration or target validation

6-10 weeks

Autoimmune & Metabolic Diseases

6-10 weeks

Case Study #1: Tumor Growth Inhibition Study Using CDX/PBMC Model for Bispecific T-Cell Engagers (TCEs)

Figure A:We selected a rational tumor model using IHC target validation and routine donor screening to ensure reliable efficacy and a consistent therapeutic window. This setup enabled large-scale studies with various dosing routes, frequencies, and other critical variables. This CDX/PBMC model demonstrated high resolution and superior efficacy in tumor volume measurements for bispecific TCE projects.

Case Study #2: In Vivo Efficacy Studies Using Dextran Sulfate Sodium (DSS)-Induced Colitis Model

This case study evaluates the efficacy of an antibody treatment in a DSS-induced colitis model, a well-established preclinical model for inflammatory bowel disease (IBD).

 

Figure 1: (A) Body weight changes and disease activity index (DAI) in DSS-treated mice demonstrated significant protection by the antibody treatment (blue) compared to the untreated control group (gray). (B) Histopathological analysis of colon tissues showed reduced inflammation and restored mucosal structure in the antibody-treated group, indicated by H&E staining. Quantitative scoring of histological sections further confirmed a significant improvement in tissue morphology following treatment.

Case Study #3: Dulaglutide in Diet-induced obesity (DIO) model for Preclinical Efficacy Testing

This case study evaluates the anti-obesity efficacy of Dulaglutide in a diet-induced obesity (DIO) model. The study monitored body weight changes, glucose tolerance, and fat mass reduction to assess the therapeutic impact of Dulaglutide on metabolic dysfunction in obese mice.

Figure 1:(A) Blood glucose levels over time showed significant improvement in glucose regulation in the Dulaglutide-treated group (blue) compared to the vehicle control. (B) The treated group exhibited enhanced glucose tolerance, as evidenced by lower glucose levels during the glucose tolerance test. (C) Quantification confirmed a significant reduction in fat mass in the Dulaglutide-treated group compared to controls. (D) Imaging data from an IVIS system further validated reduced fat accumulation in the treated group, correlating with improved metabolic outcomes.

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