ORIC Pharmaceuticals Provides Initial Phase 1b Data for ORIC-944, Operational Highlights for 2023, and Anticipated Upcoming Milestones
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Insights
The recent advancements in ORIC Pharmaceuticals' clinical trials, particularly the Phase 1b monotherapy data for ORIC-944, show promising results in metastatic prostate cancer treatment. The reported half-life of >10 hours indicates a sustained drug presence, potentially reducing dosing frequency and enhancing patient compliance. The absence of CYP autoinduction, a common issue with first-generation PRC2 inhibitors, suggests a lower risk of drug-drug interactions and a more stable pharmacokinetic profile. Robust target engagement, as evidenced by the significant decrease in H3K27me3 levels, indicates effective inhibition of the PRC2 complex, which plays a critical role in gene silencing and is implicated in cancer progression. The favorable safety profile, with only grade 1 and 2 treatment-related adverse events, is crucial for patient quality of life and may differentiate ORIC-944 from other treatments, potentially positioning it as a best-in-class therapy.
ORIC Pharmaceuticals' financial position appears robust, with a cash reserve of $256.2 million as of September 30, 2023, which is expected to fund operations into 2026. This runway is supported by the $85 million private placement financing from healthcare specialist funds, reflecting investor confidence in the company's pipeline. The focus on developing therapies for resistant oncological conditions, a market with high unmet needs, suggests potential for significant future revenues. However, investors should consider the inherent risks of clinical development, including the possibility of future dilutive financing or strategic partnerships that may affect share value. The projected initiation of combination studies and the anticipation of pivotal studies by 2025 are key milestones that could impact stock performance, contingent on positive clinical outcomes and regulatory developments.
Within the oncology pharmaceuticals market, ORIC Pharmaceuticals is positioning itself in the competitive landscape of NSCLC and prostate cancer treatments. The company's focus on addressing therapeutic resistance could meet a critical market gap, as resistance to existing treatments remains a significant challenge in cancer care. The potential best-in-class profiles of ORIC-944 and ORIC-114, if validated in later-stage trials, could disrupt existing treatment paradigms and capture significant market share. The strategic decision to pursue combination therapies, a growing trend in cancer treatment, may enhance the clinical effectiveness and marketability of ORIC's candidates. Monitoring the progression of ORIC's pipeline through upcoming milestones will be crucial for stakeholders to assess the company's market potential and strategic position.
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
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced initial data for its PRC2 inhibitor ORIC-944, operational highlights for 2023, and anticipated upcoming milestones.
“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 and86% 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 September 30, 2023, cash, cash equivalents and investments totaled
Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 11:15 a.m. PT. A live webcast will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma. Beyond these three product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
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 the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 6, 2023, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Contact:
Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com
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