According to the FDA, 89% of drugs that enter phase 1 trials across the biopharma industry ultimately fail to advance to regulatory approval. We think this is unacceptable.
Presage is leading a fundamental revolution in the way cancer drugs are developed. The power of the CIVO™ technology lies in its potential for testing experimental drugs in human patients years earlier than possible with conventional means. Development decisions can be made based on signs of efficacy in the most important context, the human cancer patient, without exposing that patient to toxic levels of a drug. Our vision is to increase the rate of clinical success from 10% to over 50% in the next decade. While ambitious, we believe that with the earlier and improved understanding of patient responses to investigational drugs and combinations that the CIVO™ platform enables, Presage will be able to help deliver what patients deserve.
Presage’s CIVO™ technology can be applied to cancer drug development in two primary ways.
- Enabling a new type of clinical trial study in human patients
Traditional clinical trials are and will remain the gold standard of establishing the clinical value of drug candidates. To maximize chances of success in clinical trials, an understanding of the optimal patient populations for those trials is critical. Translational studies employing preclinical models often are used to understand responsive tumor contexts and generate hypotheses for subsequent testing in the clinic. However, translation of data from preclinical models to human patients is imperfect.
Presage’s CIVO™ microinjection platform provides a path to study response directly in the human patient, but far more quickly than traditional studies, with multiple drugs in each patient, and without exposing the patient to toxicity from systemic dosing. This approach allows for interrogation of more patient stratification questions in drug programs at an earlier stage, avoiding failures later in clinical development.
The benefit of the Presage approach in the clinic is even more profound when studying drug combinations. There are simply too many permutations of drug combinations and patient populations to afford investigation of every option. Presage provides an elegant means of solving this problem. By assessing up to eight different drug combinations in each patient, Presage’s clinical approach can address the factorial problem facing drug developers. The platform has the potential to understand sensitivity and response to several different combinations of drugs in dozens of different tumor types. This information can be invaluable in driving decision-making for drug combination programs.
- Identifying novel, effective drug combinations in preclinical models
Researchers throughout the cancer field are using increasingly more sophisticated preclinical animal models that better represent patients in the clinic, including models of drug sensitivity and resistance, and patient-derived xenografts to represent interpatient disease heterogeneity.
Presage enables this type of preclinical modeling to be taken a step further. Our direct, intratumoral microinjection allows for drug combination studies to be conducted at a scale not previously feasible for in vivo work. The CIVO™ technology allows for the direct comparison of multiple drug candidates and combinations in a single tumor model, both reducing the need for large numbers of animals and allowing rapid prioritization of dozens to hundreds of drug combinations. Instead relying on broad, often misleading in vitro screens, our partners can now evaluate a broad range of drug combinations in a greater range of more informative, in vivo models of cancer.