Initial Phase 1b monotherapy data for ORIC-944 in metastatic prostate cancer demonstrates potential best-in-class profile, including half-life >10 hours, robust target engagement and well tolerated safety profile, supporting advancement for combination development
Initiation of combination study of ORIC-944 with AR inhibitor(s) in metastatic prostate cancer expected in first half of 2024 and program update expected in mid-2024
Initiation of multiple dose expansion cohorts for ORIC-114 in patients with mutated NSCLC expected in first half of 2024 and updated Phase 1b data expected in first half of 2025
Cash and investments expected to fund operating plan into 2026
“2023 was a landmark year for ORIC with both ORIC-114 and ORIC-944 generating clinical proof of concept data that position them as potential best-in-class therapies for NSCLC and prostate cancer, respectively. Additionally, with the completion of an
Initial Phase 1b Data for ORIC-944
- As of
December 10, 2023 , the initial Phase 1b monotherapy data for ORIC-944, a potent and selective allosteric inhibitor of PRC2, in patients with metastatic prostate cancer demonstrated:- Potential best-in-class drug properties, including clinical half-life consistent with preclinical prediction of >10 hours, which is superior to other PRC2 inhibitors and supports QD dosing;
- No signs of CYP autoinduction that is seen with first-generation PRC2 inhibitors;
- Robust target engagement with maximal decrease (≥75%) in H3K27me3 in monocytes from peripheral blood samples at doses as low as 200 mg QD, with low inter-patient variability; and
- Favorable safety with only grade 1 and 2 treatment-related adverse events at dose levels corresponding with strong target engagement.
- Emerging profile with superior drug properties support advancement into combination development in prostate cancer with AR inhibitor(s).
2023 Key Accomplishments
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor
- Presented initial data from the ongoing Phase 1b dose escalation trial for patients with EGFR or HER2 exon 20 mutated non-small cell lung cancer (NSCLC) at the
ESMO Congress 2023. Initial data demonstrated potential best-in-class profile, with favorable safety and both systemic and CNS activity in heavily pretreated patients, with 81% of patients having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline. - Presented preclinical data for ORIC-114 at
ESMO Congress 2023, demonstrating potent activity across atypical mutations in EGFR, thus expanding the potential patient population.
ORIC-944: a potent and selective allosteric inhibitor of PRC2
- Presented preclinical data highlighting a comprehensive biomarker strategy for the ongoing Phase 1b trial in metastatic prostate cancer at the 2023 AACR Annual Meeting.
- Demonstrated via preclinical studies the potential for ORIC-944 to synergize with enzalutamide and other AR inhibitors in prostate cancer.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73
- Presented initial data from Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma at the 2023 ASH Annual Meeting. Initial data demonstrated preliminary evidence of clinical antimyeloma activity and immune effects, as well as a clean safety profile, with only grade 1 and 2 treatment-related events in heavily pre-treated patients.
- Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024, and company plans to pursue strategic partnership for combination studies.
Discovery Pipeline:
- Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibitors as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR Annual Meeting.
- Advanced ORIC-613, a novel, highly selective PLK4 inhibitor, through IND enabling studies.
Corporate Highlights:
- Strengthened cash position with
$85 million private placement financing from new and existing healthcare specialist funds in the second quarter of 2023.
Anticipated Program Milestones
- ORIC-944 initiation of combination study with AR inhibitor(s): 1H 2024
- ORIC-944 program update: mid-2024
- ORIC-114 initiation of dose expansion in multiple cohorts: 1H 2024
- ORIC-114 updated Phase 1b data: 1H 2025
Financial Guidance
As of
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 the continued clinical development of ORIC-114 and ORIC-944; ORIC-114 and ORIC-944 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-114 and ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program 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-114 and ORIC-944 to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts 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; the potential market for our product candidates, and the progress and success of competing therapeutics currently available or in development; 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
Source:
2024 GlobeNewswire, Inc., source