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BioInvent initiates Phase I/IIa study

mikael oredsson bioinvent

BioInvent International 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, a rare, life-threatening brain tumor that mainly affects children.

The study initiation follows the earlier announced partnership between BioInvent, its TB-403 project partner Oncurious, 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.

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.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. A paper in Cell in February 2013 (Cell, 152, 1065-76, 2013), highlighted for the first time that PlGF plays a role in the growth and spread of medulloblastoma. The paper was based on pre-clinical research conducted by Prof Rakesh Jain from the Massachusetts General Hospital at Harvard Medical School (Boston) and the team of Prof Peter Carmeliet from Vesalius Research Center, VIB Katholieke Universitiet, Leuven, Belgium.

Treatment with TB-403 in pre-clinical models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. TB-403 has been shown to have a favorable safety profile in previous clinical trials in healthy volunteers and adult patients with various types of solid tumors.

The drug candidate TB-403 is jointly owned by BioInvent and the Belgian biopharma company Oncurious NV.

“The initiation of this study is a key step in the development of this new targeted potential treatment for children with devastating brain cancers. We are looking forward to be working with NMTRC’s experienced investigator network to complete this study in a timely manner,” commented Michael Oredsson, CEO of BioInvent.

“We are pleased to announce the initiation of this important Phase I/IIa study with TB-403, a key corporate milestone for Oncurious. Given the encouraging pre-clinical data generated with TB-403 in Leuven and Boston, we are hopeful that this novel antibody, targeting placental growth factor, will provide an improved treatment option for children afflicted with this lethal brain tumor,” said Dr Patrik De Haes, Executive Chairman of Oncurious.