Oncurious NV, an oncology company, announced that the FDA has completed the safety review of its Investigational New Drug (IND) Application and have concluded that the proposed paediatric clinical investigation can proceed. The Investigational New Drug (IND) Application is for a phase I/IIa study that will evaluate the efficacy and safety of TB-403 for the treatment of relapsed or refractory medulloblastoma. This is a rare, life-threatening brain tumour that mainly affect children.
The study, which is planned to commence in Q1 2016, will be conducted at a number of specialist centers in the United States. Initial results from the study are expected by early 2017.
TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival.
Treatment with TB-403 in pre-clinical models for medulloblastoma has demonstrated beneficial effects on tumour growth and survival. The antibody can potentially be used in other paediatric cancer indications, including neuroblastoma, Ewing sarcoma or alveolar rhabdomysarcoma.
The favourable safety profile of TB-403 has been demonstrated in previous clinical trials in healthy volunteers and adult patients with various types of solid tumours.
Dr Patrik De Haes, executive chairman of Oncurious commented, "We are delighted that the FDA has accepted our IND for TB-403. This is a major milestone for Oncurious and paves the way for us to commence a phase I/IIa study evaluating TB-403 in a range of rare pediatric brain cancers in the coming months. Based on the pre-clinical data that has been generated we are optimistic that this novel antibody could provide pediatric oncologists with a better treatment option for children afflicted with these life-threatening tumours."