Accelerating Oncology Drug Discovery Through Translational Preclinical Research

In Vivo Pharmacology

Evaluating Therapeutic Efficacy in Relevant Oncology Models

Successful oncology drug development requires clear evidence that a therapeutic candidate produces meaningful anti-tumor activity, engages its intended target, and demonstrates disease-modifying potential. Franklin Biolabs provides customized in vivo pharmacology studies designed to evaluate therapeutic efficacy, characterize dose-response relationships, and assess target engagement across a broad range of clinically relevant cancer models.

Our scientists collaborate closely with sponsors to design and execute studies that generate robust, reproducible, and decision-enabling data. By integrating clinically relevant tumor models with translational endpoints, we help advance programs from early proof-of-concept through candidate selection and preclinical development.

Our capabilities include:

• Proof-of-concept and therapeutic efficacy studies
• Dose-ranging and dose-response characterization
• Combination therapy studies
• Disease progression and tumor growth inhibition assessment
• Customized study design and protocol development
• Syngeneic tumor models
• Xenograft and patient-derived xenograft (PDX) models
• Humanized mouse models
• Orthotopic tumor models
• Metastasis models
• Longitudinal study designs supporting preclinical decision-making

Oncology Drug Delivery & Administration

Enabling Precise Therapeutic Delivery

Successful oncology therapeutic development often depends on accurate and reproducible delivery to target tissues. Franklin Biolabs provides expertise in specialized administration techniques across multiple species, supporting studies involving biologics, small molecules, antibody-drug conjugates (ADCs), radiopharmaceuticals, cell therapies, gene therapies, and advanced delivery platforms.

Our capabilities include:

• Intravenous administration
• Intratumoral administration
• Intraperitoneal administration
• Oral dosing
• Subcutaneous administration
• Image-guided dosing procedures
• Localized tumor delivery techniques
• Support for biologics, small molecules, ADCs, viral vectors, radiopharmaceuticals, and cellular therapies

Tumor Biology & Functional Assessment

Measuring Outcomes That Matter

Understanding therapeutic efficacy requires more than measuring tumor size alone. Franklin Biolabs provides comprehensive tumor biology and functional assessment services that evaluate anti-tumor activity, disease progression, immune responses, and treatment mechanisms across a variety of oncology models.

By integrating tumor response outcomes with molecular biomarkers, PK/PD analyses, imaging, and histopathological findings, we help sponsors develop a comprehensive understanding of therapeutic activity, from target engagement and biological response to meaningful anti-cancer effects.

Our capabilities include:

• Tumor volume measurement
• Tumor growth inhibition (TGI) assessment
• Survival studies
• Metastasis evaluation
• Immuno-oncology response assessment
• Tumor microenvironment characterization
• Cell proliferation and apoptosis analysis
• Functional outcome measures

Bioanalysis, Biomarkers & PK/PD

Connecting Drug Exposure to Biological Activity

Generating translational data is critical for understanding how therapies engage their targets and produce meaningful pharmacological effects. Franklin Biolabs provides integrated biomarker and PK/PD support to help sponsors characterize mechanism of action, establish exposure-response relationships, and strengthen confidence in candidate selection.

Our approach combines pharmacokinetic evaluation, pharmacodynamic assessment, target engagement strategies, and biomarker analysis to establish clear relationships between drug exposure, biological response, and efficacy outcomes.

Our capabilities include:

Pharmacokinetics & Pharmacodynamics

• PK analysis
• PD assessment
• Exposure-response modeling
• Target engagement studies
• Mechanism-of-action evaluation

Biomarker Analysis

• Tumor-specific biomarkers
• Predictive and prognostic biomarkers
• Immune response biomarkers
• Cytokine and inflammatory markers
• Translational biomarker selection

Bioanalysis

• Plasma and tissue bioanalysis
• LC-MS/MS drug quantification in plasma, tumors, and tissues

Biodistribution

• Biodistribution studies
• Tumor and tissue distribution analysis
• Radiolabeled compound studies
• Vector genome quantification (qPCR/ddPCR)

Immunogenicity

• Anti-drug antibody (ADA) testing
• Humoral immune response
• Cellular immune response
• T-cell response characterization
• Immune monitoring assay

Preclinical Oncology Imaging

Visualizing Therapeutic Distribution, Tumor Progression & Response

Advanced imaging technologies complement biomarker and PK/PD analyses by providing non-invasive assessment of therapeutic distribution, target engagement, tumor progression, procedural accuracy, and treatment response. Franklin Biolabs offers preclinical imaging capabilities that support translational oncology research by helping sponsors correlate imaging findings with molecular, pharmacological, and functional endpoints throughout preclinical development.

Imaging also enables longitudinal evaluation of tumor growth and therapeutic response within the same subjects, strengthening translational confidence while supporting efficacy studies, biodistribution assessments, image-guided procedures, and treatment monitoring.

Our capabilities include:

• Bioluminescence imaging (BLI)
• Fluorescence imaging
• Magnetic Resonance Imaging (MRI)
• Computed Tomography (CT)
• Positron Emission Tomography (PET)
• Ultrasound imaging
• Longitudinal imaging assessments
• Imaging biomarker evaluation
• Image-guided procedures

Toxicology & Safety Pharmacology

Assessing Safety and Functional Risk

Comprehensive safety evaluation is essential for advancing oncology therapeutics toward clinical development. Franklin Biolabs provides oncology-focused toxicology and safety pharmacology services designed to assess treatment-related adverse effects, target organ toxicity, immune responses, and overall safety profiles.

Our capabilities include:

• Oncology safety pharmacology studies
• General toxicology studies
• Dose-escalation assessments
• Target organ toxicity evaluation
• Immunotoxicity studies
• Safety biomarker assessment
• Tolerability studies

Oncology Pathology & Tissue Analysist

Understanding Biological Impact

Histological and tissue-based analyses provide critical insight into tumor biology and therapeutic response. Franklin Biolabs offers comprehensive oncology pathology and tissue analysis services that help characterize treatment effects at the cellular and molecular level.

Our scientists employ quantitative and qualitative approaches to evaluate tumor architecture, proliferation, apoptosis, immune cell infiltration, angiogenesis, and biomarker expression, providing the biological context needed to support preclinical development decisions.

Our capabilities include:

• Histopathology
• Immunohistochemistry (IHC)
• Multiplex immunofluorescence
• In situ hybridization
• Tissue biomarker analysis
• Tumor microenvironment characterization
• Quantitative pathology
• Cellular and molecular characterization
• Tumor and metastatic tissue analysis