From clinical development plan to phase I/IIa study
A private biotech company required assistance to realize their ambition to turn their targeted brain delivery technology platform into a medicinal product. As a first assignment, SMS-oncology prepared a (pre)clinical development plan outlining the strategy to obtain Proof of Concept with the Sponsor’s lead compound for the treatment of brain metastases and primary brain cancers. Subsequently, SMS-oncology developed the protocol for the Phase I/IIa study, which has been executed by SMS-oncology in patients with glioblastoma multiforme or brain metastasis from solid tumors. In further support of the ongoing clinical development, SMS-oncology performed a global feasibility assessment for a follow-on Phase IIb study to take place in 11 countries.
From clinical development plan via healthy volunteer study to phase I study
A stock exchange listed biotech company with a first-in-human, first-in-class, targeted agent initially asked SMS-oncology to prepare a clinical development plan that should specifically address the choice for target profile and positioning, target indications and tumor type(s), drug combination(s) and trial design.
SMS-oncology prepared a de-risked clinical development plan including a clinical trial strategy to obtain Proof of Concept. SMS-oncology’s main recommendation was to consider performing a healthy volunteer study before entering specific patient populations as this step would save time and money, as well as provide the safety/tolerability and pharmacokinetic data required to continue clinical development. The clinical development plan and the recommendations were endorsed by two leading cancer experts.
Due to the close collaboration throughout the strategic planning and healthy volunteer study, upon successful completion of the latter, SMS-oncology seamlessly executed a continuous infusion, “3+3 design” dose escalating Phase Ib study in patients with solid tumors at two European cancer centers.
Clinical development plan helps to raise venture capital money
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.