ORIC-114 / ORIC Pharma, Voronoi - LARVOL DELTA

ORIC Pharmaceuticals Announces Focused Registrational Clinical Development Plans for Lead Programs, Extended Cash Runway, and Updated Corporate Milestones (GlobeNewswire) - "ORIC-114:...Given favorable enrollment for ORIC-114 in the 1L EGFR exon 20 monotherapy cohort and the 2L+ atypical EGFR cohort, ORIC now expects to provide a comprehensive data update during 2H 2025 that will include these two cohorts along with cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20. ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with 1L EGFR exon 20 has recently been initiated. Initial data from this trial in addition to ORIC-114 data as a monotherapy in 1L EGFR atypical mutations are expected in mid-2026. ORIC expects to initiate Phase 3 trial(s) for ORIC-114 in 1L NSCLC in 2026, in EGFR exon 20, HER2 exon 20, and/or atypical EGFR mutations. ORIC does not currently plan to pursue registrational trials of ORIC-114 in 2L EGFR and 2L+ HER2 exon 20 NSCLC..."

EGFR exon 20 • HER2 exon 20 • New P3 trial • P1 data • P1/2 data • Non Small Cell Lung Cancer

ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: ORIC Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Updates (GlobeNewswire) - "ORIC anticipates the following upcoming data milestones: (1) ORIC-114 (NSCLC): (i) 1H 2025: 2L EGFR exon 20 and 2L+ HER2 exon 20; (ii) 2H 2025: 2L+ EGFR atypical; (iii) 1H 2026: 1L EGFR exon 20; (iv) Mid-2026: 1L EGFR exon 20 combination with SC amivantamab and 1L EGFR atypical; (2) ORIC-944 (mCRPC): 4Q 2025 / 1H 2026: Combination with AR inhibitors."

P1 data • P1/2 data • Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer

ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: ORIC Pharmaceuticals

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ORIC Pharmaceuticals Provides…Anticipated Upcoming Milestones (GlobeNewswire) - "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."

New trial • Oncology

ORIC Pharmaceuticals Provides...Anticipated Upcoming Milestones (GlobeNewswire) - "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."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer

ORIC Pharmaceuticals Announces Clinical Supply Agreement to Evaluate ORIC-114 in Combination with Amivantamab for the First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations (GlobeNewswire) - "Phase 1b combination trial of ORIC-114 and subcutaneous amivantamab in patients with 1L NSCLC with EGFR exon 20 insertion mutations expected to initiate in Q1 2025, with initial data in mid-2026...ORIC Pharmaceuticals...announced that the company has entered into a supply agreement with Janssen Research & Development, LLC...to evaluate ORIC-114, a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor, in combination with subcutaneous (SC) amivantamab, Johnson & Johnson’s fully-human EGFR-MET bispecific antibody, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations....Under the terms of the agreement, ORIC will conduct and sponsor the trial and Johnson & Johnson will provide SC amivantamab. ORIC maintains development and commercial rights to ORIC-114 and is free to expand the program in combination with other agents."

Commercial • EGFR exon 20 • New P1 trial • P1 data • Non Small Cell Lung Cancer

ORIC Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Updates (GlobeNewswire) - "Third Quarter 2024 and Other Recent Highlights: (i) ORIC-114:...Expect to report updated Phase 1b data in the first half of 2025."

P1 data • Solid Tumor

Voronoi, stock price soars on expectations for new lung cancer drug… Market cap exceeds 2 trillion [Google translation] (Money Today) - "The market cap of Voronoi has already exceeded 2 trillion won...Clinical data for lung cancer new drugs VRN07 and VRN11 are expected to be confirmed in the first half of next year...The recent rise in Voronoi's stock price cannot be left out by expectations for non-small cell lung cancer treatment VRN07 (ORIC-114) and VRN11...Oric is known to be concentrating its research capabilities on VRN07 as its core pipeline. It is expected to confirm the results of phase 1b clinical trials as early as next year and enter phase 2b. The goal is to then apply for accelerated approval in 2026....VRN11, which Voronoi is conducting its own clinical trials, is expected to confirm interim data in the first half of next year."

Clinical data • Filing • Stock price • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ORIC-114, a highly selective, brain penetrant EGFR and HER2 inhibitor, demonstrates best-in-class properties against Exon 20 insertions and other atypical EGFR mutations (EORTC-NCI-AACR 2024) - P1/2 | " ORIC-114 is exquisitely selective in kinome analysis, demonstrating superiority to all current clinical small molecule inhibitors tested, including firmonertinib, zipalertinib and BDTX-1535. ORIC-114 demonstrated best-in-class properties, including brain penetrance, superior selectivity across the kinome, potent activity across atypical mutations in EGFR, including PACC mutations and Exon 20 insertion mutations, and evidence of molecular response in patients. ORIC-114 is a promising therapy for NSCLC patients with atypical mutations in EGFR, including those with active CNS metastases, and is currently being evaluated in a global clinical trial (NCT05315700)."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

ORIC Pharmaceuticals Presents Data Further Supporting Potential Best-In-Class Profile of ORIC-114 to Treat EGFR Exon 20 Insertions and Other Atypical Mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "ORIC Pharmaceuticals, Inc...announced the company presented a poster highlighting certain best-in-class properties of ORIC-114, a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor, to treat EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics....Demonstrates regressions in all EGFR mutant in vivo models tested, including cell-derived xenografts, patient-derived xenografts and intracranial models that encompass exon 20 insertion and atypical mutant models. An in vivo model with complex atypical mutant EGFR dosed with ORIC-114 notably shows 100% tumor regressions and all tumors experienced a complete response....In head-to-head comparisons with firmonertinib, zipalertinib, lazertinib and BDTX-1535, ORIC-114 has superior kinome selectivity with no off-target kinase liabilities identified."

Preclinical • Oncology • Solid Tumor

ORIC Pharmaceuticals Announces Presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "In an expanded preclinical comparative analysis, ORIC-114 demonstrated best-in-class properties including brain penetrance, superior kinome selectivity, potent activity across EGFR PACC mutations and exon 20 insertion mutations, relative to firmonertinib, zipalertinib, and BDTX-1535. Additionally, evidence of molecular response in ctDNA from patients whose tumors harbored PACC mutations and exon 20 insertion mutations was observed with ORIC-114 treatment."

Preclinical • Oncology • Solid Tumor

ORIC Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Updates (GlobeNewswire) - "ORIC-114: 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....Expect to report updated Phase 1b data in the first half of 2025."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi, will VRN07 receive accelerated approval in 2026? “Aggressive expansion of U.S. clinical trials” [Google translation] (Nate) - "A notable change occurred in the global clinical study of Voronoi's non-small cell lung cancer drug candidate 'VRN07'...The other party to the technology transfer, Oric Pharmaceuticals (hereinafter referred to as Oric), a Nasdaq-listed company in the U.S., aggressively expanded the ORIC-114 clinical trial...As the clinical research and commercialization of ORIC-114 accelerates, attention is drawn to whether it will benefit Voronoi...According to related industries on the 13th, Oric recently revised and announced the ORIC-114 clinical plan and increased the number of patients registered for phase 1/2 clinical trials from 280 to 350 The number of clinical sites was greatly expanded from 26 to 34. In addition to the United States, the United Kingdom, Australia, and Poland were added as clinical site regions. In particular, full-fledged clinical trials in the Greater China region were announced by including Taiwan and Hong Kong as clinical areas."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi, will VRN07 receive accelerated approval in 2026? “Aggressive expansion of U.S. clinical trials” [Google translation] (Nate) - "In addition, Oric posted the expected clinical completion date for ORIC-114 as March 2026. In fact, the target date for accelerated approval of ORIC-114 by the U.S. Food and Drug Administration (FDA) is 2026....According to Canter Fitzgerald, an American biotechnology research center, global sales of ORIC-114 (excluding Greater China) are estimated to be up to 900 billion won....On this day, Yuanta Securities suggested a target stock price of 80,000 won for Voronoi, saying that clinical studies of VRN07 and VRN11, two of Voronoi's non-small cell lung cancer treatment candidates, are progressing without problems. In particular, it was explained that the Voronoi target price of 80,000 won only reflected the values ​​of VRN07 and VRN11."

NDA • PDUFA • Sales projection • Stock price • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

U.S. Metis returns Voronoi technology transfer materials... ‘There is no obligation to return advance payment’ [Google translation] (Medipana) - "Voronoi announced on the 26th that it had received back the exclusive license for a phosphorylation enzyme (kinase) inhibitor that had been technology transferred to the American bio company METiS Therapeutics (hereinafter referred to as Metis) two years ago...Voronoi explained through a disclosure that Metis had received technology transfer and developed it at the stage before deriving the candidate material, but the rights were returned due to changes in Metis' business environment and development strategy. We plan to decide whether or not to develop it in the future after reviewing the development data so far....Meanwhile, in the case of Voronoi's flagship pipeline, non-small cell lung cancer treatment VRN07 (ORIC-114), its technology transfer partner, Oric Pharmaceuticals, is accelerating clinical trials by completing the expanded phase 1 clinical trial in the first half of next year and starting phase 2 immediately."

Licensing / partnership • Trial status • Oncology • Solid Tumor

ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC (GlobeNewswire) - "ORIC Pharmaceuticals...announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Based upon these data, ORIC selected the two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations. The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC....'We...plan to report results in the first half of 2025'."

EGFR exon 20 • HER2 exon 20 • P1 data • Trial status • Non Small Cell Lung Cancer

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Updates (GlobeNewswire) - "Fourth Quarter 2023 and Other Recent Highlights: (i) ORIC-114:...Expect to initiate dose expansion of Phase 1b trial in multiple cohorts in the first half of 2024 and expect to report updated Phase 1b data in the first half of 2025; (ii) ORIC-944:...Expect to initiate combination study with AR inhibitor(s) in the first half of 2024 and provide a program update in mid-2024; (iii) ORIC-533:...Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024..."

New P1 trial • New trial • Trial status • Multiple Myeloma • Solid Tumor

Cantor Fitzgerald bullish on ORIC Pharmaceuticals, stock initiated with overweight rating (Investing.com) - "On Friday, Cantor Fitzgerald initiated coverage on ORIC Pharmaceuticals...assigning an Overweight rating to the clinical-stage oncology-focused biotech company. The firm's optimistic stance is primarily influenced by the potential of ORIC's key drug candidates in the oncology space...The firm's analyst believes ORIC-114, an oral EGFR/HER2 exon 20 inhibitor, has a high chance of becoming a leading drug in its category, particularly for lung cancer treatment. This drug's ability to penetrate the brain and its differentiation in the market are seen as strong points that justify the company's current valuation...Additionally, ORIC-944, an oral PRC2 inhibitor, is perceived to have a favorable risk/reward profile within the large prostate cancer market....the initial public offering (IPO) of ArriVent provided a valuation comparison that favored ORIC-114 in the Ex20 lung cancer space."

Commercial • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Voronoi approves phase 1 clinical trial plan for lung cancer new drug candidate in Taiwan [Google translation] (HIT News) - "Voronoi...has approved an clinical trial designation (IND) for the non-small cell lung cancer (NSCLC) new drug candidate 'VRN11 (development code name)' currently under development from the Taiwan Food and Drug Administration (TFDA), following Korea last year. It was announced on the 31st that it had been received...'VRN07 (ORIC-114)', a treatment for EGFR Exon20 INS mutant non-small cell lung cancer....Positive interim results from phase 1 clinical trials have been announced. Oric plans to expand the number of patients to 280 and begin phase 2b clinical trials to apply for accelerated approval next year."

Enrollment status • New P1 trial • Regulatory • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Effect of Food on the Pharmacokinetics of ORIC-114 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: ORIC Pharmaceuticals | Recruiting ➔ Completed

Trial completion

ORIC Pharmaceuticals Provides Initial Phase 1b Data for ORIC-944, Operational Highlights for 2023, and Anticipated Upcoming Milestones (GlobeNewswire) - "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."

New trial • P1 data • Trial status • Non Small Cell Lung Cancer • Prostate Cancer

Ph 1/2 Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: ORIC Pharmaceuticals | Phase classification: P1 ➔ P1/2 | N=42 ➔ 280 | Trial completion date: Mar 2025 ➔ Mar 2026

Enrollment change • Phase classification • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

ORIC Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operational Updates (GlobeNewswire) - "The Phase 1b trial of ORIC-114 is ongoing to determine the candidate RP2Ds for dose optimization and the selection of the final RP2D. Expansion cohorts will enroll patients with EGFR exon 20 insertion mutations that are EGFR exon 20 inhibitor-naïve and that have been previously treated with amivantamab, as well as patients with HER2 exon 20 insertion mutations and atypical EGFR mutations. The company expects to report updated Phase 1b data in the first half of 2025....Ongoing enrollment in a Phase 1b trial of ORIC-944 in patients with advanced prostate cancer. Expect to report initial safety, PK/PD, and preliminary antitumor activity data in the first quarter of 2024."

EGFR exon 20 • HER2 exon 20 • P1 data • Trial status • Prostate Cancer

Effect of Food on the Pharmacokinetics of ORIC-114 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: ORIC Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open