Challenges with Patient Stratification
Although precision medicine has advanced considerably, it remains a major challenge to predict a patient’s susceptibility to new drugs. This is especially true for cancer therapeutics targeting proteins somatically mutated in patient tumors. Tight restrictions on clinical trial enrollment based only on recurring, high-confidence gain- or loss- of- function mutations keeps enrollment small, limiting statistical confidence. While a large number of patients could benefit from any given drug, many present with Variants of Unknown Significance (VUSs), negating eligibility. Many targeted cancer therapy trials are known to be missing patients who may benefit.
The StratiVar Platform
StratiVar optimizes clinical trials enrollment by proactively assessing the susceptibility of all single amino acid variations of a targeted protein to a novel therapeutic. These assessments are derived from drug-specific Deep Mutational Scans (DMS), centered on verified human data controls, and are translated into actionable insights including drug-sensitivity profile and predicted probabilities of patient response for clinical trial designers and physicians. StratiVar enhances enrollment and lowers the barrier for acceptance of novel trial designs by the FDA.
| Program | Target | Discovery | Pre-clinical | Phase I | Phase II | Phase III | More Info |
|---|---|---|---|---|---|---|---|
| CB-01 | Lysosomal Storage Disease with High Unmet Need |
More Info
CB-01 is a discovery-stage program focused on a lysosomal storage disorder with significant unmet medical need.
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| Program | Target | Discovery | Pre-clinical | Phase I | Phase II | Phase III |
|---|---|---|---|---|---|---|
| CB001 | Lysosomal Storage Disease with High Unmet Need |
CB001 Program Overview
CB001 is a discovery-stage program focused on a lysosomal storage disorder with significant unmet medical need. The program aims to address disease progression at its molecular root cause.
| Program | Target | Discovery | Pre-clinical | Phase I | Phase II | Phase III | More Info |
|---|---|---|---|---|---|---|---|
| CB-01 | Lysosomal Storage Disease with High Unmet Need |
More Info
CB-01 is a discovery-stage program focused on a lysosomal storage disorder with significant unmet medical need.
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Increased Success Rates
By optimizing trial enrollment to patients predicted to respond, StratiVar increases the chance of a successful trial and FDA approval.
Accelerated Development
StratiVar streamlines the process of clinical trial design through the application of high-quality functional data.
Personalized patient population
By establishing the probability of drug-sensitivity and drug-resistance for all tested variants, StratiVar ensures that only the most-likely to respond patients are enrolled for clinical trials.
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