Oncoceutics Release: ONC201 Clinical Trial Results Accepted For 2016 ASCO Poster Discussion

Philadelphia, PA (May 19, 2016) – Oncoceutics, Inc. announced that results of a phase 1 dose escalation clinical trial and subsequent expansion phase in advanced solid tumors with its lead product, ONC201, will be presented as part of a poster discussion session at the annual conference of the American Society of Clinical Oncology (ASCO). The poster (abstract #2514; poster #214) will be displayed in Hall A on Sunday, June 5, 2016, from 8 AM until 11:30 AM and presented during a poster discussion session from 11:30 AM until 12:45 PM in the Arie Crown Theatre as part of the section “Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics.”

The phase 1 clinical trial, conducted by Mark Stein, MD, medical oncologist at Rutgers Cancer Institute of New Jersey (CINJ), was designed with an accelerated dose escalation – single patient cohorts requiring no adverse events greater than grade 1 prior to dose escalation – based on pre-clinical toxicology data that indicated a benign safety profile for ONC201. The phase 1 dose escalation study achieved its primary objective to establish a recommended phase 2 dose (RP2D), and the subsequent expansion phase confirmed the safety profile of ONC201, with a total of 28 patients evaluable for safety and no patients experiencing adverse events greater than grade 1 that were attributable to study drug.

The study was designed to assess safety, not efficacy, as the primary endpoint. However, despite the 15 different tumor types, the late stage of disease, and the limited treatment exposure for many subjects, a number of patients demonstrated evidence of tumor engagement, including tumor cell death, normalization of disease-associated tumor markers, stable disease and pain reduction in metastatic sites. For example, among the group of six patients with castration-resistant metastatic prostate cancer, three patients showed stable disease at three months, one patient showed stable disease at six months, one patient had a PSA drop and one patient had radiographic tumor shrinkage. In addition, among the five patients with metastatic endometrial cancers, two patients showed stable disease at three months including one patient who is still on study after nine months, and one patient showed a mixed response.

Oncoceutics recently announced that ONC201 antagonizes dopamine receptor D2, which is a member of the GPCR superfamily of therapeutic targets that have largely been untapped in oncology. Physiological engagement of DRD2 was confirmed in the CINJ clinical trial where 23 out of 28 patients who were treated with ONC201 had elevation of serum prolactin, a clinical biomarker of DRD2 antagonism that also suggests ONC201 penetrates the blood brain barrier, a desirable feature for oncology drugs addressing tumors located in the central nervous system.

“It is exciting to be part of the development of this novel oncology compound,” said Dr. Stein, the study’s principle investigator. “The results of this trial demonstrate ONC201’s unprecedented safety profile and early efficacy signals warrant continuation of development in cancer indications. I look forward to continuing to work with Oncoceutics to bring this exciting new drug to patients.”

“We are delighted to see the results of ONC201’s first clinical trial presented at the American Society of Clinical Oncology,” said Wolfgang Oster, MD, PhD, CEO of Oncoceutics. “Leading researchers from various disciplines have joined our efforts to identify this drug’s true potential and uniqueness in oncology. We appreciate in particular the contributions of Drs. Stein, Kauffman and Bertino and the Rutgers Cancer Institute of New Jersey to this first-in-human study”.

The link to the abstract is available here.

Oncoceutics and its collaborators will have two additional poster presentations at ASCO: 1) Hun Ju Lee, MD, from The University of Texas MD Anderson Cancer Center highlighting the ongoing clinical trial in Non-Hodgkin’s Lymphoma; and 2) Jessica Wagner from the El-Deiry laboratory at the Fox Chase Cancer Center discussing the impact of ONC201 on metastasis and immune cell recruitment in preclinical models.

About Rutgers Cancer Institute of New Jersey

Rutgers Cancer Institute of New Jersey (www.cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center. As part of Rutgers, The State University of New Jersey, the Cancer Institute of New Jersey is dedicated to improving the detection, treatment and care of patients with cancer, and to serving as an education resource for cancer prevention. Physician-scientists at the Cancer Institute engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community.

About Oncoceutics

Oncoceutics, Inc. is a clinical-stage drug discovery and development company targeting potent suppressor pathways in human cancer. The first lead compound that entered clinical development from this program is ONC201, a small molecule with an active angular structure and a first-in-class mechanism of action that causes significant anti-tumor activity in a variety of human cancers. The company recently completed a successful phase I study in solid tumors and has begun phase II clinical programs in both solid and hematological malignancies. Oncoceutics has been awarded several competitive grants for its development programs with ONC201 and its other candidates in this new class of compounds. 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.

Visit Oncoceutics or contact Alex Varney for more information.

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