ORIC Pharmaceuticals Announces Initiation of Phase 1b Study with ORIC-101 in Patients with Cancer
- Category: Small Molecules
- Published on Monday, 13 May 2019 16:19
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Clinical study to evaluate the potential of ORIC’s novel glucocorticoid receptor antagonist to be used in combination with Abraxane®
SOUTH SAN FRANCISCO, CA, USA I May 13, 2019 I ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on the discovery and development of novel therapies against treatment-resistant cancers, announced the initiation of patient dosing in a Phase 1b clinical study of ORIC-101 in combination with nab-paclitaxel (marketed as Abraxane® by Celgene Corporation) in patients with advanced solid tumors.
“Phase 1b initiation of ORIC-101 in patients with cancer represents a major milestone for ORIC,” said Jacob Chacko, MD, Chief Executive Officer. “ORIC’s in-house discovery team, based on findings originating from Dr. Charles Sawyers’ laboratory, identified and developed a selective and potent oral inhibitor of the glucocorticoid receptor (GR), which has been linked to treatment resistance to multiple classes of anti-cancer therapeutics across a variety of solid tumors. Building on our recently completed study in healthy volunteers, we are looking forward to this first clinical study of ORIC-101 through which we hope to begin demonstrating the potential of ORIC-101 to benefit patients with cancer.”
The Phase 1b trial is a dose finding, multi-center, open label study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical efficacy of ORIC-101 combined with nab-paclitaxel in patients with advanced solid tumors. Following identification of the recommended Phase 2 dose of ORIC-101 in combination with nab-paclitaxel, ORIC intends to enroll patients into expansion cohorts in selected tumor types based upon GR levels using its proprietary immunohistochemistry assay.
Subsequent to this initial Phase 1b study of ORIC-101 in combination with nab-paclitaxel, ORIC also plans to initiate additional Phase 1b studies of ORIC-101 in combination with other anti-cancer agents, including with androgen receptor modulators in patients with advanced prostate cancer and with immunotherapy agents. Ongoing and planned clinical studies of ORIC-101 are supported by research conducted at ORIC and recent clinical studies of ORIC-101 in healthy volunteers, which demonstrated that ORIC-101 appeared to be safe and well-tolerated, with a pharmacokinetic profile sufficient for oral once-daily dosing and pharmacodynamic activity suggestive of effective target engagement.
“Despite many new anti-cancer therapies, resistance remains a significant barrier to improved outcomes in most patients with advanced cancers,” said Pratik Multani, MD, Chief Medical Officer. “We are excited to evaluate the potential of ORIC-101 to overcome what we believe to be a major mechanism of resistance, overexpression of GR. This first clinical trial kicks off a robust clinical development plan to evaluate ORIC-101, the first of our programs to enter the clinic, in combination with multiple classes of anti-cancer agents across various indications that span the range of solid tumor malignancies.”
Further details about the clinical study are available at ClinicalTrials.gov (NCT03928314).
About ORIC Pharmaceuticals
ORIC Pharmaceuticals is a privately held, clinical-stage oncology company focused on making cancer treatments more effective by addressing mechanisms of resistance. ORIC’s lead program, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to treatment resistance to multiple classes of anti-cancer therapeutics across a variety of solid tumors. ORIC’s pipeline also includes an orally-available small molecule inhibitor of CD73, as well as other undisclosed programs targeting mechanisms of oncology therapy resistance. ORIC’s scientific founders are Charles Sawyers, MD, and Scott Lowe, PhD, who have long records of discovering novel targets in cancer that have led to innovative treatments. The company has assembled strong leadership and scientific teams and a board with extensive experience in drug development and financing. ORIC is funded by leading biotechnology investors, including The Column Group, Topspin Partners, OrbiMed, EcoR1, Fidelity, Foresite and others. ORIC is headquartered in South San Francisco, California.
SOURCE: ORIC Pharmaceuticals