Early results in brain cancer clinical trials for Oncoceutics? lead molecule ONC201, an orally active small molecule DRD2 antagonist, suggest that the drug can kill cancer cells but not normal cells and may be effective in patients with a specific genetic mutation in their tumor known as the H3 K27M mutation.
About 50-60% of children with high-grade glioma (and 70-90% of children with Diffuse Intrinsic Pontine Gliomas, or DIPG) have the H3 K27M mutation. About 10% of adult gliomas have the H3 K27M mutation.
The US Food and Drug Administration has invited Oncoceutics, a clinical-stage drug discovery and development company with a novel class of compounds, called ?imipridones,? that selectively target G protein-coupled receptors for oncology, to present its clinical data for adult and pediatric patients treated with ONC201 to its Pediatric Oncology Subcommittee on June 20, 2019
The meeting will provide Oncoceutics with the opportunity to present its clinical data for patients treated with ONC201, including studies for both adult and pediatric patients with gliomas containing the H3 K27M mutation, a disease that has been recognized to be an area of high unmet medical need. Additionally, the meeting enables Oncoceutics to receive feedback from the subcommittee on issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of ONC201 for pediatric use.
?We are honored and grateful for the opportunity to present to the Pediatric Oncology Subcommittee of the ODAC,? said Wolfgang Oster, MD, PhD, Chief Executive Officer and Chairman of Oncoceutics. ?ONC201 has shown biological activity that we hope will translate into the clinic and eventually make a difference in patients? lives. We look forward to furthering the clinical development of ONC201 with the support and guidance of the FDA.”