BioInvent International announces that the FDA has completed the safety review of its Investigational New Drug (IND) application and have concluded that the proposed pediatric clinical investigation can proceed.
The 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 tumor that mainly affects 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 tumor growth and survival. The antibody can potentially be used in other pediatric cancer indications, including neuroblastoma, Ewing sarcoma or alveolar rhabdomysarcoma.
A favourable safety profile of TB-403 has been demonstrated in previous clinical trials in healthy volunteers and adult patients with various types of solid tumors.
“We are delighted that the FDA has accepted our IND for TB-403. This is a milestone for commencing the phase I/IIa study evaluating TB-403 in rare pediatric brain cancers according to plans communicated in December 2015. The study will be conducted at an attractive cost and efficacy signals in patients will provide opportunities to approach the FDA regarding expedited approval. TB-403 may in this scenario get a rapid pathway to launch,” says Michael Oredsson, CEO of BioInvent.
The TB-403 drug project is conducted in cooperation with Oncurious, a subsidiary of the Belgian biopharma company ThromboGenics. BioInvent is paying half of the development costs and has the right to 40 percent of all future revenue from the project.