Consulting on clinical strategies for a novel cancer immunotherapy

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 a development program.

Solution

Our consultant, Rob Johnson conducted desk research and physician interviews to identify patient populations that could be amenable to cancer vaccine development.

The ideal clinical trial for a cancer vaccine is with a group of patients that have minimal residual disease, intact immune systems and at least 18 months of expected survival. There is a trade-off between patients that are most likely to respond to a cancer vaccine (i.e. early-stage disease) which would require a lengthy clinical trial, and those with aggressive disease requiring a more rapid clinical trial which may sacrifice the chances of observing a clinical benefit.

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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