Challenge:

A US-based cancer vaccine company developing a peptide-based product was in clinical trials in its lead indication. Recent laboratory research had revealed the target antigens were also expressed on a number of other solid tumor types, and the company wanted to assess which of those indications were the most attractive for expanding the program.

Solution:

Alacrita conducted desk research and physician interviews to identify the patient populations that could be most amenable to cancer vaccine therapy and clinical development. Findings suggested that the ideal clinical trial for a cancer vaccine enrolls a group of patients that have minimal residual disease, intact immune systems and at least 18 months of expected survival. We also found a clinical planning trade-off between patient disease stage (and consequent likelihood of response to a cancer vaccine), and anticipated clinical trial duration. We identified a number of possible clinical development options that met our client’s requirements, including an exploratory clinical trial that could be conducted rapidly to provide evidence of biological activity to help justify investment in a larger, randomized clinical program.


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