Gain critical insights earlier in the oncology drug development process

Traditional mouse models can show encouraging data, but these responses often fall short in later-stage trials. Presage's CIVO® (Comparative In Vivo Oncology) microdosing technology delivers quantitative evidence of a drug's effects on a patient’s tumor in the Phase 0 setting.

+ A bridge between cancer biology and clinical responses

Clinical development of novel oncology agents takes years, costs millions of dollars, and the likelihood of FDA approval is less than 10%.
Phase I trials provide preliminary safety and pharmacokinetic data, but the investigational effect on the tumor is still unclear.
Often, the anti-tumor drug activity observed in laboratory and mouse models are not sustained when patients are treated with the same agents during clinical trials, because preclinical tests are unable to replicate the complexities and unique behaviors of the human immune system and tumor microenvironment.

Presage is pioneering a new early oncology drug development process using patented CIVO® technology. CIVO simultaneously evaluates microdoses of multiple drugs or drug combinations in a patient’s tumor to determine drug responses and their impact on the tumor microenvironment.

CIVO is intended to:

  • Save development time with rapid analysis
  • Evaluate multiple drug candidates and combinations in parallel, providing insights on mechanism of action, efficacy, and immune modulation of a drug based on real tumor microenvironment response
    • When evaluating multi-drug combinations:
      • The synergistic mechanisms can be elicited, rather than extrapolating from the proposed additive effects
      • Resistance pathways can be evaluated to identify optimal drug combinations
  • Reduce patient exposure to potentially toxic drugs
  • Prioritize more promising drug candidates and combinations to accelerate development timelines and efficiently use valuable resources
T cell attacking cancer cell

Obtaining results with CIVO means more time focused on the investigational assets that hold the most promise for patients.

See how CIVO works

+ A network of support for our clinical collaborators

Our team is experienced in all aspects of the clinical drug development process—from operations and scientific leadership to quality assurance and regulatory support. We integrate seamlessly into your drug development process so you can continue focusing on developing life-saving therapies.

Clinical Operations

  • Clinical site qualification, training, and oversight
  • Shipment of clinical supplies
  • Data management and biostatistics

Scientific Leadership

  • Strategic study design
  • Development and quantitative analysis of drug-specific response biomarkers
  • Histology, image analysis, statistics, and reporting

Quality Assurance

  • Setting standards for health and authority acceptance and actionable client deliverables

Regulatory support

  • Study sponsorship
  • FDA communication
  • Document preparation and submissions

Additionally, our team is constantly working with new partners to qualify them as clinical sites, which expands the network of support for CIVO.

Find out how CIVO technology can enhance your drug discovery approach.

+ A defined regulatory pathway

In 2006, the FDA recognized the potential of Phase 0 trials and released guidance for industry on microdosing studies. Since then, the agency has simplified the process for using exploratory investigational new drugs which aligns perfectly with the CIVO platform's capabilities.

The Center for Drug Evaluation and Research and Center for Devices and Radiological Health recognize CIVO as an accepted research tool.* To allow for clinical trial efficiencies, the Master Access File for CIVO can be cross-referenced for any new trial that uses CIVO.

*Does not require a pre-market approval or 510k submission.

See how CIVO is helping to advance the science of oncology drug innovation

See ongoing trials

QUESTIONS ABOUT HOW TO INTEGRATE CIVO INTO YOUR ONCOLOGY DEVELOPMENT STRATEGY?

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