Brown University Award of $3.4M includes funds for IND and First Clinical Trial of ONC212

Philadelphia, PA (June 8, 2020) – Oncoceutics announced today a Brown University award of $3.4 million that will be used to support a group of research teams for preclinical research, IND-enabling studies and a first-in-human clinical trial for Oncoceutics’ imipridone ONC212. As part of this award, Oncoceutics has received a $1M subaward to complete the IND-enabling studies for ONC212. ONC212 will be the third imipridone to enter clinical trials for oncology and is an agonist for the G protein-coupled receptor (GPCR) GPR132 and the mitochondrial protease ClpP, both novel targets that are highly expressed in cancer cells.

The award goes to Wafik El-Deiry, MD, PhD, FACP, Director of the Cancer Center at Brown University as the overall Principal Investigator (PI). The awarded project, “ONC212 as a novel therapy for pancreatic cancer,” builds upon Dr. El-Deiry’s previous article demonstrating ONC212 inhibits tumor cell growth in vitro and in vivo, promotes cell death and is active against patient-derived models of pancreatic tumors. Moreover, ONC212 demonstrates synergy with chemotherapeutic drugs for pancreatic cancer such as 5-fluorouracil, irinotecan, oxaliplatin as well as the RTK inhibitor crizotinib.

The supported project spans preclinical, translational, and clinical research aimed at enabling ONC212 as a new treatment for pancreatic cancer. Further preclinical studies will involve ONC212 efficacy investigations in vitro and in vivo in the acidic microenvironment of pancreatic cancer and biomarker evaluations with GPR132 and ClpP. Additionally, Oncoceutics will be responsible for GLP manufacturing, IND-enabling GLP toxicology studies and FDA IND submission. Upon IND acceptance, a first-in-human Phase I trial for single agent ONC212 will be conducted through the Brown University Oncology Group (BrUOG) for the clinical study to open at the Lifespan Cancer Institute in patients with metastatic pancreatic cancer who have progressed on approved therapies.

ONC212 efficacy has also been demonstrated previously in other tumor types including AML, glioblastoma, melanoma and hepatocellular cancer. ONC212 originated from Oncoceutics’ imipridone discovery platform and is protected by a composition of matter patent issued in the USA and other global markets. A future Phase I/II clinical trial in refractory AML is the subject of an alliance between MD Anderson and Oncoceutics.

“We are extremely grateful for having the opportunity to conduct this research,” said Dr. El-Deiry who serves as Associate Dean for Oncologic Sciences at the Warren Alpert Medical School. “Our lab has been working on imipridone small molecules for more than a decade. Pancreatic cancer is a devastating disease, and our preclinical studies have identified imipridone ONC212 as a high priority drug candidate for bench-to-bedside translation.”

“We are excited to continue working with Dr. El-Deiry and the team at Brown University and fully support his efforts in this field,” said Varun Prabhu, PhD, Vice President of R&D at Oncoceutics. “This grant will enable the introduction of a third imipridone ONC212 into the clinic that will expand the ability of the class to target a new GPCR beyond dopamine receptors.”

About Oncoceutics
Oncoceutics, Inc. is 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. The first lead compound to emerge from this program is ONC201, an orally active small molecule DRD2 antagonist. The company is supported by grants from NCI, FDA, Musella Foundation, XCures, Cancer Commons, and a series of private and public partnerships. Visit Oncoceutics for more information.

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