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news.BioInvent International has secured approval from the US Food and Drug Administration (FDA) to start the proposed pediatric clinical investigation of TB-403 for the treatment of relapsed or refractory medulloblastoma.
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The FDA has accepted the company’s investigational new drug (IND) application for the phase I/IIa study of TB-403, which is expected to start in the first quarter of this year,
BioInvent will carry out the study at several specialist centers in the US, with initial results anticipated by early 2017.
BioInvent CEO Michael Oredsson said: "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."
TB-403 is a humanized monoclonal antibody against placental growth factor which is expressed in various types of cancer, including medulloblastoma.
BioInvent said high expression of the PlGF receptor neuropilin 1 has been demonstrated to correlate with poor overall survival.
Treatment with TB-403 in pre-clinical models for medulloblastoma showed beneficial effects on tumor growth and survival, the company said.
The antibody can potentially be used in other pediatric cancer indications such as neuroblastoma, Ewing sarcoma or alveolar rhabdomysarcoma.
The TB-403 drug project is carried out in partnership with ThromboGenics’s subsidiary Oncurious.
BioInvent is paying half of the development costs and has the right to 40% of all future revenue from the project.