OPN-6602 / Opna Bio - LARVOL DELTA

Opna Bio Receives Orphan Drug Designation for OPN-6602, an Oral EP300/CBP Bromodomain Inhibitor, for Multiple Myeloma (Businesswire) - "Opna Bio...announced today that the FDA has granted orphan drug designation (ODD) to one of its lead programs, OPN-6602, for the treatment of multiple myeloma (MM)....The Phase 1 study in patients with relapsed or refractory multiple myeloma (NCT06433947) is taking place at multiple sites in the U.S. Opna Bio expects to complete the single agent, dose-escalation phase of the trial in 2026."

Orphan drug • Trial status • Multiple Myeloma

OPN-6602, an Orally Bioavailable EP300/CBP Bromodomain Inhibitor, Targets Multiple Myeloma through Suppression of IRF4 and MYC (ASH 2024) - P1 | "The efficacy of OPN-6602 in combination with dexamethasone (dex) and/or with pomalidomide (pom) or mezigdomide (mezi) was evaluated in the OPM-2 xenograft model. Similar findings were observed in a dog GLP toxicology study. OPN-6602 is currently being evaluated in patients with MM in the Phase I clinical trial OPN6602-C01 (NCT06433947)."

Hematological Malignancies • Multiple Myeloma • Oncology • EP300 • IRF4 • MYC

OPN-6602 Combinations Demonstrate Complete Tumor Regression in Preclinical Multiple Myeloma Models (Businesswire) - "In MM mouse xenograft models, OPN-6602 showed 71% tumor suppression as a single agent, and 100% tumor regression when combined with dexamethasone, pomalidomide or mezigdomide with a sustained duration of response. RNA sequencing of treated tumors showed that OPN-6602 downregulated key MM driver and signature genes, and has the potential to overcome resistance mechanisms to standard-of-care regimens."

Preclinical • Multiple Myeloma

A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma (ASH 2024) - P1 | "Dose limiting toxicities, treatment-emergent adverse events and changes in safety and lab parameters will be characterized in order to identify the RP2D. The primary objective and endpoint for dose expansion of OPN-6602 monotherapy or in combination with dexamethasone is to evaluate the preliminary antitumor activity using overall response rate based on the 2011 International Myeloma Working Group (IMWG) response criteria.Eligibility criteria include a confirmed diagnosis of MM per IMWG criteria, disease that is relapsed or refractory to 3 or more different prior lines of therapy that include immunomodulatory agents, proteasome inhibitors and an anti-CD38 antibody, measurable disease and adequate hematologic, renal and liver function.This multi-center study (NCT06433947) is currently open in the United States with additional sites planned to open in Switzerland, United Kingdom and the European Union."

Clinical • Combination therapy • Monotherapy • P1 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • BRD3 • EP300 • IRF4

Opna Bio Announces 2024 ASH Presentations Highlighting Interim Data from Phase 1 Combo Study of BET Inhibitor OPN-2853 with Ruxolitinib in Myelofibrosis, and Promising Preclinical Data with EP300/CBP Bromodomain Inhibitor OPN-6602 in Multiple Myeloma (Businesswire) - "The data presentations will include an interim analysis of the ongoing Phase 1 study of OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor being tested in combination with ruxolitinib, a Janus kinase 1/2 (JAK1/2) inhibitor, in patients with myelofibrosis who are no longer responding to ruxolitinib alone. A second presentation features preclinical data with OPN-6602, an oral, small molecule inhibitor of the E1A binding protein (EP300)..."

P1 data • Preclinical • Melanoma • Multiple Myeloma • Oncology • Solid Tumor

Opna Bio Doses First Patient in Phase 1 Study in Multiple Myeloma with OPN-6602, an EP300/CBP Bromodomain Inhibitor (Businesswire) - "Opna Bio announced that it has dosed the first patient with OPN-6602, a potent and selective EP300/CBP bromodomain inhibitor, in a Phase 1 clinical study in multiple myeloma. The trial is expected to enroll up to 130 total patients with relapsed or refractory multiple myeloma at sites in the U.S....The first patient was dosed at The START Center for Cancer Research in Grand Rapids, Michigan, with Dr. Andrew Sochacki, principal investigator, leading the study team."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

OPN6602-C01: Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Opna Bio LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Hematological Malignancies • Multiple Myeloma • Oncology

OPN6602-C01: Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Opna Bio LLC

Combination therapy • Monotherapy • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

OPN-6602, a potent dual EP300/CBP bromodomain inhibitor, targets multiple myeloma through concomitant suppression of IRF4 and c-MYC (AACR 2024) - "The effects of OPN-6602 with dexamethasone (dex) or lenalidomide (len) on the growth of OPM-2 and MM1.S cells were evaluated in a matrix combination study. The pharmacokinetic profile is favorable for oral QD dose administration due to a high Cmax (19 µg/mL at 24 mg/kg) and short half-life (T1/2 = 1.5 hr). A first-in-human study of OPN-6602 in patients with MM is planned for 2024."

Hematological Malignancies • Lung Cancer • Multiple Myeloma • Oncology • Solid Tumor • BRD4 • CREBBP • EP300 • IRF4 • MYC

Opna Bio Presents Promising Preclinical Data in Multiple Myeloma with OPN-6602 and in Malignant Mesothelioma with OPN-9840 Showing Significant Tumor Growth Inhibition at the American Association of Cancer Research Annual Meeting (Businesswire) - "Opna Bio...presented promising preclinical data in...programs, OPN-6602, a dual EP300/CBP inhibitor in multiple myeloma....Data were shared at the American Association of Cancer Research (AACR) Annual Meeting....Significantly reduced tumor growth as single agent (71% tumor growth inhibition, or TGI) in the OPM-2 multiple myeloma cell xenograft model. Demonstrated increased anti-tumor activity (>100% TGI) and sustained duration of response in combination studies with dexamethasone, pomalidomide and mezigdomide....A first-in-human Phase 1 study of OPN-6602 is planned for mid-2024 in patients with multiple myeloma."

New P1 trial • Preclinical • Multiple Myeloma

OPN-6602, a dual EP300/CBP bromodomain inhibitor modulates androgen-driven transcription, including MYC, in mCRPC. (AACR-NCI-EORTC 2023) - No abstract available

Oncology • Prostate Cancer • EP300