On January 9, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported its program updates and announced upcoming key milestones (Press release, ORIC Pharmaceuticals, JAN 9, 2023, View Source [SID1234626091]).
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"In 2022, we made significant progress across our clinical pipeline, advanced multiple preclinical discovery programs, and further strengthened the balance sheet," said Jacob M. Chacko, MD, chief executive officer. "All three clinical programs commenced dosing last year, have demonstrated good oral bioavailability and dose proportional increases in exposure across multiple cohorts, and are steadily advancing in dose escalation without reaching MTD as we expand clinical trial sites globally. Furthermore, with the recent equity investment by Pfizer we have extended our cash runway into 2025, giving us flexibility to frontload Project Optimus-related dose optimization before selecting final RP2D for all three programs, and we expect to report initial clinical data for ORIC-533, ORIC-114, and ORIC-944 in the second half of 2023."
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 (Free AACR Whitepaper) in the second quarter of 2022 and at ASH (Free ASH Whitepaper) 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 and Australia.
Presented compelling brain exposure and antitumor activity of ORIC-114 in preclinical NSCLC EGFR exon 20 intracranial models at AACR (Free AACR Whitepaper) 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 $25 million of ORIC common stock in a registered direct offering. As of December 31, 2022, cash, cash equivalents and investments totaled approximately $228 million, which the company expects will be sufficient to fund its operating plan into first half of 2025.
Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2022, at 11:15 a.m. PT. A live webcast will be available through the investor section of the company’s website at View Source A replay of the webcast will be available for 90 days following the event.