The company previously received the first part of the award in March 2015 and successfully completed part one.
Part two of the Fast-Track SBIR award totals $1.4 million over two years (September 2015-August 2017) and will support a phase II clinical trial with single agent ONC201 at the Dana-Farber Cancer Institute.
Andrew Chi, MD, PhD, Assistant Professor of Neurology / Neuro-Oncology, will lead the study, which will enroll 30 patients with advanced GBM who have been treated previously with first-line therapy of radiation and temozolomide.
ONC201 is a first-in-class, orally active, small molecule that penetrates the blood brain barrier and exhibits strong anticancer activity in aggressive preclinical models of GBM.
The company recently completed the first-in-man study of ONC201 at the Rutgers Cancer Institute of New Jersey and defined the recommended phase 2 dose (RP2D) that will be used in this trial and for subsequent clinical studies.
Oncoceutics CEO and the principal investigator of the award Wolfgang Oster said: "We are delighted to receive this grant award from the NCI to advance the clinical development of ONC201 in GBM, which is one of the lead indications for this product.
"The SBIR award is an important indication of the significant clinical and commercial opportunity of ONC201. We are extremely grateful to the NCI for its continued support of ONC201 as we execute our development of this unique therapy."