Challenge

A group of healthcare investors with a long track record in the industry, but no biotechnology or research background, were interested in licensing a university project aimed at bladder cancer. On its face, the asset appeared to have the potential to replace BCG as a first line therapeutic option in non-muscle invasive bladder cancer. The investors asked Alacrita to conduct a "reality check" of the opportunity and provide a high level development roadmap and comment on the attractiveness of the asset to investors.

Solution

Alacrita's expert team assessed the strength of the preclinical data and interviewed the academic inventors. We concluded that the results to date were interesting but that further studies were needed to build out the dataset. One of Alacrita's clinical oncologists developed an outline clinical pathway from Phase 1 to 3, and we obtained preliminary trial feasibility, timelines and budgets from a qualified CRO. Our biologics CMC specialist drew up a manufacturing plan, with associated timeframes and associated budgets, that included technology transfer to a CDMO and manufacture of IND-enabling batches through to commercial-ready supplies. We also characterized the competitive environment and the rapidly evolving clinical standards of care, and drew conclusions about the risk-reward balance. Finally, we provided a view about the investor attractiveness and likely hurdles to success.


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