On May 13, 2019 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on the discovery and development of novel therapies against treatment-resistant cancers, reported 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 (Press release, ORIC Pharmaceuticals, MAY 13, 2019, View Source [SID1234536231]).

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"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).