ORIC Pharmaceuticals reports promising early data for ORIC-944 and ORIC-114, with multiple upcoming clinical milestones and partnerships.
Quiver AI Summary
ORIC Pharmaceuticals, Inc. announced encouraging early safety and efficacy results from its ongoing Phase 1b trial evaluating ORIC-944 in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The company has entered a clinical trial collaboration with Johnson & Johnson to assess ORIC-114 in combination with amivantamab for treating non-small cell lung cancer (NSCLC). Over the next 18 months, ORIC expects seven data readouts and potential initiation of registrational trials in late 2025 and early 2026. The firm also reported strong progress in 2024, including new collaborations, an expanded leadership team, and a successful $125 million PIPE financing that extends its cash runway into late 2026. The solid early results for both ORIC-944 and ORIC-114 underline the company's focus on tackling therapeutic resistance in cancer treatment.
Potential Positives
- Announced encouraging early safety and efficacy data in the ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC, demonstrating significant PSA response in several patients.
- Entered into a strategic clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 for NSCLC, indicating strong industry partnerships.
- Expected seven data readouts across ORIC-114 and ORIC-944 clinical programs over the next 18 months, suggesting a robust developmental pipeline.
- Strengthened cash position with a $125 million PIPE financing, providing a solid financial runway to fund operations into late 2026.
Potential Negatives
- Press release suggests reliance on ongoing clinical trials with uncertainties regarding patient enrollment and data outcomes which could materially impact future results.
- Potential risks highlighted include dependency on third-party collaborations, which might affect operational efficiency and product development timelines.
- The cautionary note indicates that actual results may differ materially from the company’s forward-looking statements, underscoring inherent risks associated with drug development.
FAQ
What are the early results for ORIC-944 in mCRPC trials?
Encouraging early data indicates deep PSA decreases and well-tolerated safety in patients receiving ORIC-944 with apalutamide.
What collaborations is ORIC Pharmaceuticals involved in?
ORIC entered collaborations with Johnson & Johnson and Bayer to evaluate ORIC-114 and ORIC-944 in clinical trials.
When will data readouts for ORIC-114 and ORIC-944 be reported?
ORIC anticipates seven data readouts across ORIC-114 and ORIC-944 clinical programs over the next 18 months.
What is the expected financial runway for ORIC Pharmaceuticals?
ORIC expects its cash and investments to fund operations into late 2026, following a recent $125 million financing.
What is the significance of ORIC-114 for NSCLC patients?
ORIC-114 targets EGFR exon 20 insertion mutations and is being evaluated for first-line treatment in NSCLC patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ORIC Insider Trading Activity
$ORIC insiders have traded $ORIC stock on the open market 3 times in the past 6 months. Of those trades, 0 have been purchases and 3 have been sales.
Here’s a breakdown of recent trading of $ORIC stock by insiders over the last 6 months:
- DOMINIC PISCITELLI (Chief Financial Officer) sold 8,851 shares.
- PRATIK S MULTANI (Chief Medical Officer) sold 8,850 shares.
- JACOB CHACKO (PRESIDENT AND CEO) sold 24,660 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ORIC Hedge Fund Activity
We have seen 62 institutional investors add shares of $ORIC stock to their portfolio, and 50 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- AVIDITY PARTNERS MANAGEMENT LP added 1,447,119 shares (+inf%) to their portfolio in Q3 2024
- BALYASNY ASSET MANAGEMENT L.P. added 1,131,066 shares (+inf%) to their portfolio in Q3 2024
- SUPERSTRING CAPITAL MANAGEMENT LP added 949,522 shares (+inf%) to their portfolio in Q3 2024
- FMR LLC removed 541,541 shares (-11.0%) from their portfolio in Q3 2024
- MILLENNIUM MANAGEMENT LLC removed 488,776 shares (-62.5%) from their portfolio in Q3 2024
- STATE STREET CORP removed 318,059 shares (-14.1%) from their portfolio in Q3 2024
- ORBIMED ADVISORS LLC removed 287,100 shares (-100.0%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC
Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations
Expects to report seven data readouts across ORIC-114 and ORIC-944 clinical programs over the next 18 months, with potential initiation of registrational trials in 2H25 and early 2026
Cash and investments expected to fund operating plan into late 2026
SOUTH SAN FRANCISCO and SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today provided early Phase 1b combination data for ORIC-944, operational highlights for 2024, and anticipated upcoming milestones.
“We made strong progress on multiple fronts in 2024, most notably with the initiation of multiple cohorts for ORIC-114 in NSCLC and ORIC-944 in mCRPC. We also forged three strategic collaborations with leading pharma partners, strengthened our leadership team to expand functional capabilities, and completed a $125 million PIPE financing, extending our cash runway into late 2026,” said Jacob M. Chacko, M.D., president and chief executive officer. “These accomplishments position us well for 2025 and beyond, with seven anticipated data readouts over the next 18 months as we advance toward potentially initiating registrational studies for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026.”
Updated Phase 1b Combination Data for ORIC-944
ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via allosteric targeting of the embryonic ectoderm development (EED) subunit. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including a clinical half-life of approximately 20 hours, robust target engagement, and a favorable safety profile.
In mid-2024, the Company initiated once daily dosing of ORIC-944 in combination with 240 mg QD apalutamide or with 600 mg BID darolutamide, as part of the ongoing Phase 1b trial in patients with metastatic castration resistant prostate cancer (mCRPC). As of the December 10, 2024 data cut-off, the Company completed the first two ORIC-944 dose escalation cohorts (n=6 patients) for the apalutamide combination. This initial experience demonstrated:
Deep prostate-specific antigen (PSA) decreases across both the 600 mg and 800 mg dose cohorts; 3 of 6 patients achieved confirmed PSA50 responses, of which 2 achieved confirmed PSA90 responses. All the PSA responses were maintained at ≥12 weeks, including a durable confirmed PSA90 response ongoing at 38 weeks.
Well-tolerated safety, with primarily Grade 1 and Grade 2 treatment related adverse events (TRAE), consistent with PRC2 and androgen receptor (AR) inhibition, and one Grade 3 TRAE of fatigue (patient remains on treatment without dose modification). The first two dose levels cleared without dose limiting toxicities or treatment discontinuations related to safety. Dose escalation is ongoing.
Dose escalation for the combination of ORIC-944 with darolutamide is also ongoing with the first dose cohort completed and the second enrolling. Preliminary clinical activity seen to date is consistent with the apalutamide combination cohort.
2024 Key Accomplishments
ORIC-114
: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor
Entered into a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous (SC) amivantamab for the 1L treatment of NSCLC patients with EGFR exon 20 insertion mutations.
Initiated a cohort to evaluate ORIC-114 monotherapy for the treatment of patients with 1L treatment-naïve EGFR exon 20 insertion NSCLC.
Announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 and the selection of two provisional recommended phase 2 doses; after which, first patients were dosed across three expansion cohorts in the Phase 1b trial of ORIC-114 in patients with mutated non-small cell lung cancer (NSCLC), including 2L EGFR exon 20 insertion (EGFR exon 20 inhibitor naïve), 2L+ HER2 exon 20 insertion, and 2L+ EGFR atypical mutations.
Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertions and other atypical EGFR mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
ORIC-944
: a potent and selective allosteric inhibitor of PRC2
Initiated dosing of ORIC-944 in combination with ERLEADA
®
(apalutamide) and in combination with NUBEQA
®
(darolutamide) in mid-2024 in the ongoing Phase 1b trial for prostate cancer.
Entered into clinical trial collaboration and supply agreements with Johnson & Johnson and Bayer to support the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors for the treatment of prostate cancer.
Reported initial Phase 1b single agent data for ORIC-944 in metastatic prostate cancer supporting advancement into combination development and demonstrating the potential as a best-in-class PRC2 inhibitor, including a clinical half-life of ~20 hours, robust target engagement, no signs of CYP autoinduction that was observed with first-generation PRC2 inhibitors, and a generally well-tolerated safety profile.
Presented preclinical data at the 2024 AACR Annual Meeting demonstrating superior drug properties and synergy data in prostate cancer models, reinforcing the promise of ORIC-944 as a potential best-in-class treatment for combination with AR inhibitors.
Corporate Highlights:
Strengthened cash position and runway with a $125 million private placement financing from new and existing healthcare specialist funds.
Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs.
Anticipated Program Milestones
ORIC anticipates the following upcoming data milestones:
ORIC-114 (NSCLC):
1H 2025: 2L EGFR exon 20
and
2L+ HER2 exon 20
2H 2025: 2L+ EGFR atypical
1H 2026: 1L EGFR exon 20
Mid-2026: 1L EGFR exon 20 combination with SC amivantamab
and
1L EGFR atypical
ORIC-944 (mCRPC):
4Q 2025 / 1H 2026: Combination with AR inhibitors
Financial Guidance
As of September 30, 2024, cash, cash equivalents and investments totaled $282.4 million, which the company expects will be sufficient to fund its operating plan into late 2026.
Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, 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 that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers, and (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer. Beyond these two 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; statements regarding the potential best-in-class properties of ORIC-114 and ORIC-944; clinical outcomes from combination studies with ORIC-944, 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, ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational studies; 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’s product candidates 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 or its clinical trial collaboration and supply agreements; the potential market for ORIC’s 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 titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, 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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