ORIC Pharmaceuticals to Present Initial Phase 1b Clinical Data for ORIC-533 in Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Rhea-AI Summary

ORIC Pharmaceuticals, Inc. announced a poster presentation on the initial Phase 1b clinical data for ORIC-533 in patients with relapsed/refractory multiple myeloma at the 65th American Society of Hematology Annual Meeting. ORIC-533 is a highly potent and selective inhibitor of CD73, currently being evaluated in an ongoing Phase 1b study. The study included heavily pretreated patients and showed good tolerability, with no dose limiting toxicities or serious adverse events. Preliminary evidence of enhanced CD8+ T-cell activation and single agent clinical activity was observed.

Positive

• ORIC-533 is a highly potent and selective inhibitor of CD73.
• The Phase 1b study included heavily pretreated patients.
• No dose limiting toxicities or serious adverse events were observed.
• Preliminary evidence of enhanced CD8+ T-cell activation and single agent clinical activity was observed.

Negative

• None.

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced a poster presentation on the initial Phase 1b clinical data for ORIC-533 in patients with relapsed/refractory multiple myeloma at the 65th American Society of Hematology Annual Meeting to be held December 9-12, 2023, in San Diego, CA.

Details of the ASH poster presentation are as follows:

Title:	Preliminary Results of the Oral CD73 Inhibitor, ORIC-533, in Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract #:	4761
Session Name:	653. Multiple Myeloma: Prospective Therapeutic Trials: Poster III
Session Date:	Monday, December 11, 2023
Presentation Time:	6:00 PM - 8:00 PM PT
Location:	San Diego Convention Center, Halls G-H

Abstract Highlights

ORIC-533 is a highly potent and selective, orally bioavailable, small molecule inhibitor of CD73, currently being evaluated in an ongoing Phase 1b dose escalation study to determine its safety, tolerability, and pharmacokinetics and selection of the recommended Phase 2 dose in patients with relapsed/refractory multiple myeloma. The study included a heavily pretreated patient population where all patients were triple-class refractory, 88% were penta-refractory, and 59% also received prior anti-BCMA/CD3 bispecific therapy or anti-BCMA CAR-T therapy. ORIC-533 was well tolerated with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and with no dose limiting toxicities, no Grade ≥ 4 TRAEs, and no treatment-related serious adverse events. ORIC-533 demonstrated good bioavailability and a plasma half-life of ~24 hours. Strong inhibition of soluble CD73 enzymatic activity was seen across all dose levels. Preliminary evidence of enhanced CD8+ T-cell activation was seen at the highest dose levels tested in both the peripheral blood and bone marrow, and early evidence of single agent clinical activity was observed. Overall, ORIC-533 demonstrated an acceptable safety profile and preliminary evidence of immune activation in this heavily pretreated patient population.

Full abstracts are available for online viewing via the ASH Annual Meeting website at Hematology.org.

About ORIC-533

ORIC-533 is a highly potent, 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. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, as well as other small molecule inhibitors of CD73 and adenosine receptor antagonists. Preclinical data demonstrated that ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment, reflective of AMP levels observed in tumors. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, as well as in ex vivo bone marrow aspirates from relapsed or refractory multiple myeloma patients.

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-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, and (3) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer. 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 ORIC-533’s clinical activity or safety profile, which may materially change as patient enrollment continues or more patient data become available; ORIC-533’s development plans; the potential advantages of ORIC-533 and ORIC’s other product candidates; and plans underlying ORIC’s clinical trials and development. 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, ORIC-533, ORIC-944 or any other 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; 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 August 10, 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

FAQ

What is the focus of ORIC Pharmaceuticals, Inc.?

ORIC Pharmaceuticals, Inc. is a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance.

What is the name of the drug being evaluated in the Phase 1b study?

The drug being evaluated in the Phase 1b study is ORIC-533.

What patient population was included in the Phase 1b study?

The Phase 1b study included patients with relapsed/refractory multiple myeloma who were heavily pretreated.

What were the key findings of the study?

The study showed good tolerability, with no dose limiting toxicities or serious adverse events. Preliminary evidence of enhanced CD8+ T-cell activation and single agent clinical activity was observed.