Oncoceutics Begins ONC201 Endometrial Cancer Trial; Receives NIH Grant

Philadelphia, PA (September 11, 2017) – Oncoceutics, Inc. announced the launch of a clinical trial of ONC201 for patients with recurrent or metastatic endometrial cancer at the Fox Chase Cancer Center. The Phase II trial, being led by Gina Mantia-Smaldone, MD, Assistant Professor in the Department of Surgical Oncology, is listed on ClinicalTrials.gov under NCT03099499 and will evaluate tumor response rate and progression-free survival. The Company also announced that it was awarded a Fast Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) totaling $1.7 million for a second study focused on an aggressive subtype of endometrial cancer called Type II.

Endometrial cancer is the most common gynecological cancer in the United States with approximately 60,000 women diagnosed annually. While often curable with surgery when caught early, outcomes are poor for patients with metastatic and/or recurrent disease. The five-year survival rate for these patients is less than 20%, and there are no FDA-approved therapeutic options. Type II endometrial cancers make up approximately 10% of all cases, and are particularly aggressive with worse outcomes.

The decision to pursue these focused Phase II clinical trials of ONC201 in endometrial cancer was driven by results seen to date in heavily-pretreated, metastatic endometrial cancer patients who were enrolled in a Phase I study of ONC201 that included multiple different types of cancer. Results from this Phase I study, recently presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO), demonstrated induction of established signaling pathways through which ONC201 exerted its antitumor activities. The study also demonstrated clinical responses, including prolonged stable disease and shrinkage of metastatic tumors in the lung and in lymph nodes of patients with endometrial cancer. In addition, preclinical evaluation of cancerous endometrial tissue shows that dopamine receptor D2 (DRD2), the target of ONC201, is upregulated in tumors compared to healthy tissue.

“I am looking forward to exploring ONC201’s activity in recurrent endometrial cancer patients in this dedicated Phase II trial,” said Dr. Mantia-Smaldone. “There are very few options available for these patients and this population has been historically underexplored in clinical trials, despite the substantial unmet need.”

“Based on the results seen to date with ONC201, we are excited to bring this new drug to our patients who have no available therapies,” said Lainie Martin, MD, Chief of Gynecologic Medical Oncology at Fox Chase Cancer Center. “Additionally, this trial will allow us to evaluate patients with various histologies and understand ONC201’s efficacy across these subtypes.”

About Oncoceutics

Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active DRD2 small molecule antagonist that is well-tolerated and effective against advanced cancers. The company recently completed a successful Phase I study in solid tumors and has begun additional Phase I/II and Phase II clinical programs in both solid and hematological malignancies. Oncoceutics and collaborative groups have received significant grants over the last two years, from institutions such as the National Cancer Institute, the U.S. Food and Drug Administration, the Pennsylvania Department of Health, and The Musella Foundation. In addition, outside interest in the company’s portfolio has resulted in several R&D alliance agreements and collaborations between Oncoceutics and leading cancer research institutions, including The University of Texas MD Anderson Cancer Center, the NIH/NCI, Harvard and the Fox Chase Cancer Center. The company has established a robust intellectual property position, including several issued patents.

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