Oncoceutics Release: Research Publications Provide Rationale For ONC201 Trials In Breast Cancer

Philadelphia, PA (May 4, 2017) – Recently, Oncoceutics collaborators have published two research articles demonstrating that Oncoceutics’ lead imipridone, ONC201, shows anti-tumor efficacy in preclinical models in several distinct subtypes of breast cancer, including triple-negative breast cancer (TNBC). TNBC, so called because its growth is not supported by estrogen, progesterone, or HER2, is a particularly aggressive subtype of breast cancer with no available targeted therapies.

One research article, published in the journal Molecular Cancer Therapeutics, from the laboratory of Dr. Wafik El-Deiry at Fox Chase Cancer Center, describes the broad-spectrum efficacy of ONC201 in TNBC, ER+ and HER2-amplified human breast cancer cell lines and mouse models, both as a single agent and in combination with taxane chemotherapies. The article goes on to demonstrate that the antitumor activity of ONC201 involves the integrated stress response and cell cycle arrest.

The other article, published in the journal Oncotarget, from the laboratory of Dr. Gen Sheng Wu at Wayne State University School of Medicine, similarly shows that ONC201 is efficacious in TNBC cells via induction of the integrated stress response. ONC201 was efficacious in TRAIL-resistant TNBC cells, however, cells with acquired resistance to ONC201 were cross-resistant to TRAIL. These results establish that ONC201 is active in preclincial models of breast cancer, particularly the TNBC subtype, and validate the involvement of the integrated stress response and TRAIL pathway in its mechanism of action.

These findings collectively form a rationale to evaluate the clinical activity of ONC201 in TNBC and other subtypes of breast cancer. As previously announced, two investigator-initiated clinical trials are in development to evaluate ONC201 in patients with advanced breast cancer. These studies are in development and will be conducted by the National Cancer Institute and the University of Wisconsin with funding from the V Foundation and the Wisconsin Partnership Program.

"These preclinical studies provide further support for testing ONC201 in clinical trials, such as our recently funded phase II trial in metastatic triple-negative breast cancer, which will incorporate an innovative dietary intervention" said Dr. Vincent Cryns, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health.

“It is very rewarding to collaborate with preeminent research groups to further characterize ONC201 and our growing portfolio of imipridones” said Dr. Varun Prabhu, Associate Director of Research and Development at Oncoceutics. “These publications, the recent presentations at the American Association for Cancer Research annual meeting, and the clinical and preclinical data currently being generated by researchers around the world, continue to indicate that ONC201 will be a promising new cancer therapy.”

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 more than $7 million in grants over the last two years, including grants from 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 between Oncoceutics and leading comprehensive cancer centers, including The University of Texas MD Anderson Cancer Center and the Fox Chase Cancer Center. The company has established a robust intellectual property position, including several issued patents.

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