Date: 2016-05-02
Type of information: Initiation of the trial
phase: 1-2a
Announcement: initiation of the trial
Company: BioInvent (Sweden) Thrombogenics (Belgium) Oncurious (Belgium) Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) (USA - MI)
Product: TB-403
Action
mechanism: monoclonal antibody. TB-403 is a humanized monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.TB-403 was in-licensed by ThromboGenics from the Flanders Institute for Biotechnology (VIB), where the therapeutic potential of anti-PlGF agents to treat cancer was first developed by Prof. Peter Carmeliet at the University of Leuven, Belgium. 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.
Disease: relapsed or refractory medulloblastoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this study is to assess the safety and tolerability profile of TB-403 (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects with relapsed or refractory Medulloblastoma. (NCT02748135 )
Latest
news: * On May 2, 2016, Oncurious announced it has initiated a Phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma. The study initiation follows the earlier announced partnership between Oncurious, its TB-403 project partner BioInvent, and the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) in the US. NMTRC is a collaboration of 25 US academic medical centers, teaching hospitals and other entities, with the purpose of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers. * On March 17, 2015, BioInvent International announced that a Phase I/IIa program with TB-403 in medulloblastoma patients is expected to be initiated during the second half of 2015. Medulloblastoma is a rare, life-threatening cancer that exclusively affects children and adolescents. The favorable safety profile of TB-403 has been demonstrated in previous clinical trials in patients with other diseases. The project is conducted in collaboration with ThromboGenics NV. TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Treatment with TB-403 in relevant animal models for medulloblastoma has furthermore demonstrated beneficial effects on tumour growth and survival. The antibody can potentially be used in other pediatric cancer indications, including neuroblastoma. The pharmaceutical project TB-403 is conducted in collaboration with the Belgian biopharmaceutical company ThromboGenics NV. BioInvent is contributing half of the development costs and are entitled to 40 percent of all future revenues from the project.
Headquartered at the Helen DeVos Children’s Hospital in Grand Rapids, MI, USA, NMTRC is the key clinical trial partner for this Phase I/IIa study. The study aims at recruiting a minimum of 27 patients, with first results expected to be reported in 2017.
* On January 7, 2016, Oncurious announced 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 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. The study is planned to commence in Q1 2016. It will be conducted at a number of specialist centers in the United States. Initial results from the study are expected by early 2017. The favorable safety profile of TB-403 has been demonstrated in previous clinical trials in healthy volunteers and adult patients with various types of solid tumors.
