Oncurious begins Phase I/IIa study of TB-403 to treat medulloblastoma

Oncurious, along with BioInvent International and Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC), has begun a Phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma.

Medulloblastoma is a rare, life-threatening brain tumour that mainly affects children.

The TB-403, co-developed by Oncurious and BioInvent, is a humanised monoclonal antibody against placental growth factor (PlGF), which is expressed in several types of cancer, including medulloblastoma.

Oncurious noted that treatment with TB-403 in pre-clinical models for medulloblastoma has showed positive effects on tumour growth and survival.

In previous clinical trials, TB-403 has been shown to have a favourable safety profile in healthy volunteers and adult patients with various types of solid tumours.

US-based NMTRC is a collaboration of 25 US academic medical centres, teaching hospitals and other entities, established with the aim of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers, and is the key clinical trial partner for this Phase I/IIa study.

The study intends to enrol a minimum of 27 patients, with first results expected to be reported next year.

Oncurious executive chairman Patrik De Haes said: "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 tumour."