Oncurious is conducting a clinical phase I/IIa study with TB-403 (anti-PlGF) to treat medulloblastoma, a rare and life-threatening brain tumor that mainly affects young children. Patient recruitment is ongoing in partnership with Beat Childhood Cancer.
Medulloblastoma is the most common malignant brain tumor, accounting for 20% of all brain tumors in children. This very aggressive type of cancer affects mostly young children between 1 and 9 years of age. It presently can only be treated through surgery followed by chemotherapy, which is very toxic and administered for about one year. In some cases children must also undergo high doses of radiation. This severely affects the IQ of young children as they grow, even after they have been cured of medulloblastoma.
As both therapies have very negative side effects, Oncurious detected this unmet medical need and is researching TB-403 (anti-PlGF) to offer an innovative alternative treatment. This compound is the antibody that combats placental growth factor (PlGF), which causes the brain tumor to develop in the child’s brain.
Clinical trial ongoing
Preclinical studies with TB-403 have already generated very promising data. The molecule has the potential to stop tumor cells from growing, thus blocking the disease process. It is expected to be much less toxic than chemotherapy, so it could offer an alternative treatment option for children suffering from medulloblastoma without side effects on healthy tissue.
A phase I/IIa clinical trial with TB-403 is ongoing. The study aims to recruit 27 patients with relapsed or refractory medulloblastoma to examine the safety of different doses. The first two of a planned four patient groups have been recruited and the trial with the third dose level is under way. For recruiting patients Oncurious is partnering with Beat Childhood Cancer. This is a collaboration of 25 universities and children’s hospitals, headquartered at the Helen Devos Children’s Hospital, which offers a nationwide network of childhood cancer clinical trials.
Orphan drug designation
In early 2017, the European Commission confirmed orphan drug designation for the Oncurious compound TB-403 for medulloblastoma. This allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is on the market.
TB-403 is being developed by Oncurious in conjunction with BioInvent International. In July 2017, Oxurion and BioInvent amended their long-standing monoclonal antibody development agreement. In the amended agreement, BioInvent assumes project lead for development of TB-403 in all oncology indications and will increase its share in the economic value of TB-403 from 40% to 50%. Both parties will continue to share equally the costs of developing TB-403 for oncology indications.