Policy & Regulation
Oric Pharmaceuticals Starts Phase 1b Study with ORIC-101 in Patients with Cancer
17 May 2019 - - US-based oncology company ORIC Pharmaceuticals has initiated patient dosing in a Phase 1b clinical study of ORIC-101 in combination with nab-paclitaxel (marketed as Abraxane by Celgene Corp.) in patients with advanced solid tumors.

The Phase 1b trial is a dose finding, multi-centre, 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.

Oric Pharmaceuticals is a privately held, clinical-stage oncology company focused on making cancer treatments more effective by addressing mechanisms of resistance.

The company's lead programme, 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 programmes targeting mechanisms of oncology therapy resistance.

The company'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.