Non-human primate (NHP) studies provide important translational evidence when advancing innovative therapeutics, specifically biologics such as antibody-based therapies (monoclonal antibodies, bi-specifics and antibody-drug conjugates (ADCs)), vaccines, gene- and cell-based therapies toward the clinic.
OncoBone provides translational expertise for study planning, protocol development, monitoring study execution, data interpretation and reporting for your drug development programs. We are flexible and work to provide an integrated approach designed around your specific needs and objectives – whether you need information about pharmacokinetics, pharmacodynamics, target engagement, biomarkers, biological activity and/or safety of your therapy.
Why are NHP studies needed?
NHP studies help to answer important questions during drug development, such as what exposure is achieved at different doses, what dose provides the desired pharmacological response, what potential safety risks emerge at clinically relevant exposures and which organs or tissues may be affected, are observed adverse effects reversible, and what is the relationship between exposure, pharmacodynamic activity and toxicity. This information is needed for IND before proceeding to clinical development.
Are you not sure if NHP studies are needed for your program? Contact us to discuss how to evaluate if the drug binds to human-relevant target, is the target pharmacologically active in NHPs, and are NHPs an appropriate species for evaluating potential adverse effects.
NHP Study Capabilities
NHP study capabilities are categorized in three groups that may overlap, depending on the study objective. We will work with you to prepare a study design where you can get the most out of your study with minimal time and associated costs to maximise the project impact on your development program.
Pharmacokinetics and Pharmacodynamics (PK/PD)
The objective is to characterize exposure and pharmacological response to help establish relationships between dose, exposure and biological effect. Studies can include:
- PK profiling
- Exposure assessment
- Pharmacodynamic endpoints
- Target engagement
- Dose–response characterization
Safety and Tolerability (preliminary and GLP-tox)
The objective is to generate comprehensive data to characterize the safety and tolerability of your candidate and identify findings that may inform subsequent development. Studies can include:
- Clinical observations, including body weight and physiological assessments
- Clinical pathology, including clinical chemistry and hematology
- Pathology and histopathology
- Toxicokinetic assessment
Biomarkers & Immunogenicity
The objective is to integrate biomarker strategies into NHP studies to strengthen understanding of mechanism, biological activity and translational relevance. Studies can include:
- Biomarker analysis
- Target engagement
- Immune-response assessments
- Cytokine and other relevant biomarker endpoints
- Anti-drug antibody (ADA) assessment, where applicable
Why work with OncoBone?
After 30 years in preclinical CRO business we understand that preclinical data must be generated with appropriate attention to scientific expertise, honouring animal welfare, uncompromised data quality, and applicable regulatory requirements.
When you work with us your studies are conducted according to an appropriate study design including applicable standards (GLP, where applicable), with appropriate quality oversight and documentation. From study initiation to final report, we maintain transparent communication and provide data to support your next development decision.
If you are interested to learn more, please contact us at info@oncobone.com.
