After a seed investment, a startup biotech had built an IP portfolio in the field of glucosinolates, chemicals found in brassica vegetables, that are potent inducers of cytoprotective enzymes and inhibitors of carcinogenesis. The company was preparing for a Series A financing to support the preclinical and early clinical development of the company’s lead compound and was putting together a business plan to underpin this process.
They asked Alacrita to provide a rational development strategy based on the research data accumulated to date, which suggested that the compound could have efficacy in a broad range of cancer types. The challenge was to identify the lead indication with the strongest scientific, clinical and commercial rationale.
Alacrita established an indications strategy for the client's novel oncology compound, delivered an expert toxicology report and acted as a ‘technical champion’ during investor presentations.
Following desk research, we worked with two leading oncologists to narrow the number of indications to two. We analyzed them to develop a clinical strategy that would generate value-creating data in a one- to two-year timeframe. This involved an assessment of the cancer biology, a selection of target patient populations, a review of clinical and non-clinical endpoints and determining the effect required to be clinically relevant.
After our client’s board approved the clinical strategy, we used an activity-based model to accurately forecast the time and costs required to execute the development program. The model calculated the overall cost of setting up the trial, recruiting patients, completing the clinical visits, monitoring, data collection, data entry into relevant databases, statistical analysis and clinical report production. We provided costings for a number of different development scenarios.
To further strengthen the investment proposition, the client commissioned Alacrita to conduct a literature review and write an expert report based on the underlying science. This report summarized the literature (epidemiology, mechanistic research, preclinical work and clinical work to date), set out what additional toxicology and preclinical efficacy studies would be required by regulatory authorities prior to starting clinical trials and provided best-estimate costings for such work.
Throughout the investment process, we provided ongoing advice and joined the client’s CEO at investor presentations to provide technical support. The company subsequently announced the first closing of the investment.