Exploratory Pharmacology

Cynbiose performs exploratory studies that provide a wealth of in vivo data regarding the drug candidate, through the association of pharmacokinetic, pharmacodynamic, histological and early safety pharmacology parameters on small to mid-sized animal cohorts.

The obtained data are critical to successfully translate preclinical results into the clinical trials. This “derisking” approach mitigates the risks before engaging in further development phases involving  significant financial commitments.

Preclinical research services

Cynbiose performs pharmacokinetics, pharmacodynamics and biodistribution studies in the clinically relevant non-human primate model. This model is indeed well-suited for drugs developed in oncology and other therapeutic areas :

• Our scientists have core competences and in-depth experience in conducting in vivo PK, PD and biodistribution studies in a translational in vivo model,
• Our teams work closely with sponsors to define customized study designs, going from the number of animals to the measured parameters necessary to generate high value-added data:
  • Administration regimen (single-dose, multiple-dosing, …), wide range of route of administrations (more information),
  • Various sampling sites and types (more information)

Pharmacokinetics / Pharmacodynamics

Our preclinical services include:

• Circulating drug kinetics following most routes of administration (more information)
• Cutting-edge expertise for in vivo central pharmacokinetics (Discover our proprietary platform Kine C3)
  • Blood sampling
  • Cerebrospinal fluid (CSF) drug levels
  • Brain microdialysis to monitor neurotransmitters, drugs or metabolites in the extracellular cerebral fluid.
• Daily clinical monitoring for the early detection of adverse effects
• Monitoring of physiological parameters and other biomarkers of interest
• Bioanalysis (more information)

Biodistribution

Biodistribution studies in a translational animal model provides critical information to support the early development of biotherapeutics, immunotherapies, gene therapies or NCE targeting specific organs.

Our services include:

• For gene therapies: unique capacity to screen animals before purchase based on clinically validated assays for antibodies against viral vectors, adenovirus, AAV, etc.
• Chronic or terminal collection of a wide range of organs, tissues and fluids (including deep biopsies guided by ultrasound imaging)
• Histology and Immunohistochemistry analysis
• Functional imaging (PET, MRI, …)

These biodistribution studies are particularly relevant for the nonclinical assessment of innovative drugs or formulations:

• Biopharmaceuticals
• Drugs targeting the CNS
• Immunotherapies
• Viral vectors such as adeno-associated viruses (AAV), adenoviruses, lentiviruses, …
• Advanced therapy medicinal products (ATMPs) such as cell therapies, CAR-T, tissue-engineered medicines
• Gene therapy medicinal products (GTMPs)
• Nanomedicines