Förberedelser för fas II kliniska studier av Fractalkine-receptor antagonisten KAN0567 inom barncancer
|Funding from Vinnova||SEK 776 535|
|Project duration||June 2017 - June 2018|
|Venture||Swelife and Medtech4Health- Project proposals to improve health|
Purpose and goal
The purpose and goal of the project was to prepare the substance KAND567 for Phase II clinical trials in cancer through i) an efficacy study in a mouse model for neuroblastoma and ii) development and manufacturing of a solid formulation of KAND567. The results from the efficacy study are currently being evaluated. A solid formulation of KAND567 has been developed and two technical batches have been produced. The business development work has resulted in the identification of several new potential partners for the further clinical development of KAND567. The goals have largely been met.
Expected results and effects
For Phase II clinical trials in cancer, a drug product with a solid formulation of KAND567 is required. A solid formulation with suitable properties has been developed and two technical batches of drug product have been produced. A preclinical efficacy study of KAND567 has been performed in a mouse model for neuroblastoma, results are currently being evaluated. Kancera has participated in 5 international industrial meetings and identified potential partners for clinical development as well as continued discussions with companies that previously have expressed interest.
Planned approach and implementation
Kancera has conducted the business development work (WP1) and coordinated the development and production of drug product (WP3). These activities have been carried out according to plan, WP3 with the help of subcontractors. The in-vivo tolerability, PK and effect studies (WP2) have been coordinated by the Department of Women´s and Children´s Health (KBH), KI and KBH has been responsible for the in-vivo work, while Kancera has contributed with the substance and analyzes. In WP2, a planned efficacy study in a genetic mouse model could not be performed due to failed breeding.