On July 23, 2019 Oncoceutics, Inc., reported a collaboration with the National Cancer Institute (NCI) funded Pediatric Preclinical Testing Consortium (PPTC) to enable tumor type selection for ONC201 clinical trials in pediatric oncology beyond diffuse midline gliomas (Press release, Oncoceutics, JUL 23, 2019, View Source [SID1234558336]).
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The PPTC program addresses key challenges associated with the development of new therapies for children with cancer by producing reliable preclinical data using genomically characterized patient-derived lines to inform indication prioritization for pediatric clinical trials. The program is funded by the NCI and agents are selected for evaluation through a competitive application process and review of submitted proposals by the PPTC steering committee.
ONC201 was selected for evaluation by the PPTC steering committee based on the promising preclinical and clinical results in adult and pediatric diffuse midline gliomas. The collaboration looks to build and expand on these findings through in vitro and in vivo testing in order to develop data to support the evaluation of ONC201 more broadly across pediatric cancers in the clinic. ONC201 efficacy will be evaluated in vitro with follow-on in vivo studies in preclinical models of pediatric glioblastoma, ependymoma, medulloblastoma, neuroblastoma, Ewing sarcoma and rhabdomyosarcoma. The PPTC studies will be conducted at the Children’s Hospital of Philadelphia for neuroblastoma, the Greehey Children’s Cancer Research Institute for sarcoma, and Ann & Robert H. Lurie Children’s Hospital of Chicago for brain cancers.
"We are excited to work with the prestigious NCI funded PPTC research group to enable the expansion of our pediatric oncology program for ONC201 beyond H3 K27M mutant gliomas" said Varun Vijay Prabhu, PhD, Associate Vice President of R&D at Oncoceutics. "This translational effort to evaluate ONC201 broadly in pediatric oncology is consistent with feedback from academic disease experts during our recent presention at FDA to the pediatric subcommittee of ODAC."
A webcast recording of the meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee that occurred on June 20, 2019 concerning the development of ONC201 for pediatric oncology can be viewed at the following link.