Establish the clinical development path to condition market approval

Purpose and goal

Establish the Clinical Development Plan for CellProtect. CellProtect is an innovative cell therapy product based on NaturalKiller (NK) cells where the primary indication is multiple myeloma (MM). The project is in clinical development phase and a Phase I / II trial in newly diagnosed MM has been performed at Karolinska University Hospital, Huddinge. We have successfully worked with a number of value-enhancing activities, to pave the regulatory path for CellProtect. CellProtect has received orphan status in the EU, which has meant high value for a future market approval.

Expected results and effects

A clinical development plan for CellProtect as an orphan drug. During the project period, CellProtect has received orphan drug status in the EU, which means that CPNP receives free guidance from EMA for design of Phase II trials and discuss the requirements for an application for market approval. We are working on evaluating the ongoing Phase I / II study and designing detailed synopsis for Phase II / III trials with defined clinical endpoints. The company participates as a partner and resource in several competence centers and cooperation projects for the development of ATMPs.

Planned approach and implementation

We have intensified our work in two areas A. The Clinical Development Plan for CellProtect B. Identification of potential VCs as well as partners both for outlicensing and manufacturing the study drug