On January 10, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that program updates and upcoming key milestones that are expected to substantially broaden and advance the company’s clinical pipeline (Press release, ORIC Pharmaceuticals, JAN 10, 2022, View Source [SID1234598455]).
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"2021 was a transformational year for ORIC during which we presented initial data from both ongoing ORIC-101 combination trials, advanced our differentiated pipeline with three IND/CTA submissions, progressed two discovery pipeline programs into lead optimization, and further strengthened the balance sheet," said Jacob M. Chacko, M.D., president and chief executive officer. "These efforts have significantly broadened our pipeline, with expected updates from our two ongoing trials of ORIC-101 in the first half of 2022 and initial Phase 1b clinical data from our other three product candidates in the first half of 2023, for a total of five clinical updates across four programs over the next 18 months."
Program Updates and Milestones
ORIC-101: Glucocorticoid Receptor (GR) Antagonist
ORIC-101 is a potent and selective GR antagonist with two distinct mechanisms of action being evaluated in two Phase 1b trials in combination with: (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. The company reported initial data from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel in the second quarter of 2021 and initial data from the Phase 1b trial of ORIC-101 in combination with enzalutamide in the fourth quarter of 2021. The company expects to provide an update on both trials in the first half of 2022.
ORIC-533: CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable CD73 inhibitor and has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule CD73 inhibitors. The FDA cleared the company’s Investigational New Drug Application (IND) for ORIC-533 in the third quarter of 2021. Based on strong mechanistic rationale and compelling preclinical single agent activity in bone marrow cells from patients with multiple myeloma, the company has initiated a Phase 1b trial as a single agent in multiple myeloma and expects to report initial data in the first half of 2023.
ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated systemic tumor regressions and strong intracranial antitumor activity in various EGFR exon 20 insertion NSCLC and HER2-positive breast cancer models. ORIC-114 also compares favorably in head to head in vivo studies versus multiple approved and clinical stage EGFR exon 20 and HER2 inhibitors. The company filed a Clinical Trial Application (CTA) in the fourth quarter of 2021. The Phase 1b single agent study will enroll patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.
ORIC-944: PRC2 Inhibitor
ORIC-944, is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2), that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. The IND for ORIC-944 was filed and cleared by the FDA in the fourth quarter of 2021. The company plans to pursue a single agent clinical development plan in metastatic prostate cancer and expects to report initial Phase 1b data in the first half of 2023.
Discovery Pipeline
In addition to the four product candidates, the company is leveraging its resistance platform in pursuit of multiple discovery research programs that focus on its expertise in precision oncology and hormone-dependent cancers. These programs highlight the company’s medicinal chemistry and structure-based drug design proficiency to target drivers of resistance in solid tumors like prostate, breast, and lung cancer that relapse with innate, acquired or bypass mechanisms of resistance. The company recently advanced two of these programs into lead optimization.
Anticipated Program Milestones
ORIC anticipates the following upcoming milestones:
ORIC-101: Updates from two Phase 1b combination trials in 1H 2022
ORIC-533: Initial Phase 1b data in 1H 2023
ORIC-114: Initial Phase 1b data in 1H 2023
ORIC-944: Initial Phase 1b data in 1H 2023
New program and/or indication to be announced in 2022
Financial Guidance
As of December 31, 2021, cash, cash equivalents and investments totaled $280.8 million, which the company expects will be sufficient to fund its operating plan into the first half of 2024.
Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022, at 3:00 p.m. ET. A live webcast will be available through the investor section of the company’s website at View Source A replay of the webcast will be available for 30 days following the event.