A small biotech company, in the early clinical stage of development of a cell based therapeutic vaccine for the treatment of cancer, required comprehensive detailed information to motivate strategic decisions with regard to the market positioning of their technology and the prioritization of the clinical target indications to pursue.
The Sponsor was in need of a clinical development plan outlining the most feasible route to obtain Proof of Concept based on product positioning and selected target indication.
SMS-oncology assessed the therapeutic anticancer vaccine landscape which resulted in advice on how to position the Sponsor’s technology. Once the best option for positioning had been selected, a list of potential cancer indications was prepared. Four criteria were used to identify and rank the most suitable indications. Based on the positioning of the technology, the selected clinical target indications, and our “hands-on” experience performing clinical cancer trials, we were able to prepare a feasible clinical trial strategy for Phase I and II studies with the goal to obtain Proof of Concept.
We summarized the outcome of our work in a clinical development plan. The Sponsor used the plan to successfully raise venture capital money, which was used to start an investigator initiated Phase I trial.