ODM-207 / Orion Corp, Dr. Reddy’s - LARVOL DELTA

Ex vivo analysis of DNA repair targeting in extreme rare cutaneous apocrine sweat gland carcinoma. (PubMed, Oncotarget) - "RNAi inhibition of RAD52-dependent HR on the other hand potentiated the efficacy of a novel BETi ODM-207. Together these results describe the first ever CAC case with a BRCAness genetic background, evaluate combinatorial DNA repair targeting, and provide a data resource for further analyses of DNA repair targeting in PALB2 deficient cancers."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • PALB2 • RAD51 • RAD52

Safety and Efficacy of Bromodomain and Extra-Terminal Inhibitors for the Treatment of Hematological Malignancies and Solid Tumors: A Systematic Study of Clinical Trials. (PubMed, Front Pharmacol) - " We retrieved and reviewed published reports on the clinical trials of twelve BET inhibitors including AZD5153, ABBV-075, BMS-986158, CPI-0610, GSK525762, OTX-015, PLX51107, INCB054329, INCB057643, FT-1101, CC-90010, and ODM-207 for patients with hematological malignancies and solid tumors and summarized their published target genes. All BET inhibitors reviewed in our study exhibited exposure-dependent thrombocytopenia, which may limit their clinical application. Moreover, further efforts are necessary to explore the optimal dosing schemes and combinations to maximize the efficacy of BET inhibitors."

Clinical • Journal • Review • Fatigue • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombocytopenia

Therapeutic targeting of estrogen receptor positive breast cancer with the BET bromodomain inhibitor ODM-207 (AACR 2018) - "The purpose of this study was to determine the anticancer activity of the novel BET bromodomain inhibitor ODM-207 in pre-clinical ER+ breast cancer models, and further, to look for cancer-associated signaling pathways suppressed by BET inhibitors.Methodology and ODM-207 is a novel, highly selective BET bromodomain inhibitor structurally distinct from JQ1 and its benzodiazepine-related derivatives. Our results indicate that the novel BET bromodomain inhibitor ODM-207, which is currently in Phase I clinical trials for treating solid tumors, causes significant growth inhibition and cell cycle arrest in pre-clinical models of ER+ breast cancer, and regulates multiple crucial signaling pathways involved in breast cancer cell cycle and survival."

Hormone Receptor Breast Cancer

First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. (PubMed, Br J Cancer) - P1/2 | "ODM-207 shows increasing exposure in dose escalation and was safe at doses up to 2 mg/kg but had a narrow therapeutic window."

Clinical • Journal • P1 data • Anorexia • Fatigue • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Targeting cancer with a novel BET bromodomain inhibitor ODM-207 (AACR 2017) - "...Methods and ODM-207 is a potent and selective BET inhibitor that is structurally unrelated to the benzodiazepine like inhibitors such as JQ1, I-BET762, and OTX015... In summary, these studies demonstrate that ODM-207 is a potent inhibitor of BET proteins in models of hematologic malignancies and solid tumors in vitro and in vivo and support its clinical development for the treatment of cancer."

Biosimilar • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Oncology • Prostate Cancer

Orion Group financial statement release for 2019 (GlobeNewswire) - "With regard to other earlier phase development projects, we are looking for partners for possible next development phases of the ODM-203 and ODM-207 molecules...We estimate that Nubeqa® will start to generate more substantial net sales growth starting from 2021-2022 and ODM-109, if successful, to have a significant impact on net sales growth from around 2022-2023."

Clinical • Sales

BETIDES: ODM-207 in Patients With Advance Solid Tumours (clinicaltrials.gov) - P1/2; N=36; Completed; Sponsor: Orion Corporation, Orion Pharma; Active, not recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ May 2019; Trial primary completion date: Dec 2019 ➔ May 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Antitumor activity of ODM-207, a novel BET bromodomain inhibitor, in nonclinical models of ER+ breast cancer as single agent and as a combination treatment (AACR 2019) - "For gene expression analyses, breast cancer cells were treated with ODM-207 or reference BET inhibitor JQ1 and differentially expressed genes were analyzed by RNA-sequencing. In summary, ODM-207, which is currently in Phase I clinical trials for treating solid tumors, causes significant growth inhibition in pre-clinical models of ER+ breast cancer and enhances antiproliferative activity of palbociclib, providing a rationale for development of a combination therapy."

BETIDES: ODM-207 in Patients With Advance Solid Tumours (clinicaltrials.gov) - P1/2; N=36; Active, not recruiting; Sponsor: Orion Corporation, Orion Pharma; Recruiting ➔ Active, not recruiting; N=144 ➔ 36

Clinical • Enrollment change • Enrollment closed