Initial Phase 1b data for three ongoing clinical trials expected in second half of 2023: ORIC-533 in multiple myeloma, ORIC-114 in EGFR/HER2-mutated cancers, and ORIC-944 in prostate cancer
Development candidate selected for PLK4 synthetic lethal breast cancer program
Cash and investments of
“In 2022, we made significant progress across our clinical pipeline, advanced multiple preclinical discovery programs, and further strengthened the balance sheet,” said
Updates and Milestones
ORIC-533: a highly potent, orally bioavailable CD73 Inhibitor
- Initiated dosing patients in a Phase 1b trial with ORIC-533 as a single agent in relapsed/refractory multiple myeloma in first quarter of 2022.
- Presented preclinical data supporting the potential of ORIC-533 in multiple myeloma at AACR in the second quarter of 2022 and at ASH in fourth quarter of 2022.
- Established a clinical development collaboration with Pfizer in the fourth quarter of 2022 for a potential Phase 2 combination study of ORIC-533 and elranatamab, Pfizer’s investigational B-cell maturation antigen (BCMA) CD3 targeted bispecific antibody.
- Filed and received clearance for a Clinical Trial Application (CTA) for ORIC-533 by the Canadian regulatory authority.
- Expect to report initial Phase 1b data for ORIC-533 in second half of 2023.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 Inhibitor
- Initiated dosing patients in a Phase 1b trial with ORIC-114 as a single agent in advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification in the first quarter of 2022 in
South Korea andAustralia . - Presented compelling brain exposure and antitumor activity of ORIC-114 in preclinical NSCLC EGFR exon 20 intracranial models at AACR in the second quarter of 2022.
- Filed and received clearance for an IND for ORIC-114 by the
US FDA in the third quarter of 2022, and initiated the first US site in the fourth quarter of 2022. - Expect to report initial Phase 1b data for ORIC-114 in second half of 2023.
ORIC-944: a potent and selective allosteric inhibitor of PRC2
- Initiated dosing patients in a Phase 1b trial with ORIC-944 as a single agent in prostate cancer in second quarter of 2022.
- Ongoing preclinical evaluation of combinations in prostate cancer and other potential indications.
- Expect to report initial Phase 1b data for ORIC-944 in second half of 2023.
Discovery Pipeline:
- The company advanced multiple targets in small molecule lead optimization, including inhibitors of polo-like kinase 4 (PLK4), which confers synthetic lethality in breast cancers with TRIM37 amplification/elevation. A novel, potent, selective, orally bioavailable PLK4 inhibitor was selected as a development candidate in the fourth quarter of 2022.
Anticipated Program Milestones
ORIC anticipates the following upcoming milestones:
- ORIC-533: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with multiple myeloma in the second half of 2023.
- ORIC-114: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with EGFR/HER2-mutated cancers in the second half of 2023.
- ORIC-944: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with prostate cancer in the second half of 2023.
Corporate Update and Financial Guidance
Concurrent with the clinical development collaboration with Pfizer for ORIC-533, Pfizer purchased
Presentation and Webcast
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding ORIC’s development plans and timelines; the potential advantages of ORIC’s product candidates and programs; plans underlying ORIC’s clinical trials and development; the expected timing of reporting initial data from the ORIC-533, ORIC-114 and ORIC-944 trials; statements regarding the potential benefits of and activity under the clinical development collaboration between ORIC and Pfizer; plans underlying any of ORIC’s other programs; ORIC’s anticipated milestones; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-533, ORIC-114, ORIC-944 or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in
Contact:
dominic.piscitelli@oricpharma.com
info@oricpharma.com
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