firstwordpharmaJune 22, 2021
Tag: ORYZON , Iadademstat , Vafidmstat
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that it will present new clinical data and attend several renowned international conferences in June and July, all to be held virtually.
Dr. Carlos Buesa, Oryzon's CEO, will attend and present a corporate update at the "Emerging Biotech Company Showcase" hosted by NewYorkBIO and the New York Stock Exchange (NYSE), which will be held on June 23. The Showcase brings together New York's financial community and a group of emerging biotech companies that are developing novel therapeutics and technologies that could revolutionize patient care.
Dr. Buesa will also attend the Spring European Virtual MidCap Event, which will take place on June 24-25, where he will hold 1x1 meetings with international investors and pharma industry professionals.
The company will present initial, preliminary data of vafidemstat's ability to reduce the inflammatory response in COVID-19 patients from the ongoing Phase II trial ESCAPE at the 31st European Congress of Clinical Microbiology and Infectious Diseases, ECCMID-2021, which will be held on July 9-12. This clinical update will be presented in an e-poster entitled "ESCAPE trial: Preliminary data on the effect of vafidemstat treatment in the COVID-19 induced immune response in hospitalized patients", available through the on-demand virtual congress platform as of July 9. ESCAPE is an open-label, randomized, double arm Phase II trial to assess the efficacy and tolerability of vafidemstat in combination with standard of care, to prevent progression of severely ill COVID-19 patients with pneumonia to Acute Respiratory Distress Syndrome (ARDS), one of the main causes of death in this disease, by reducing the patient's inflammatory response to the infection. In accordance with the embargo terms and conditions for presentation at ECCMID-2021, data will be released on the same day as the communication, July 9.
Finally, Dr. Tamara Maes, Oryzon's Vice President and President of Oryzon's Scientific Advisory Board, and Dr. Robert Soliva, Oryzon's Head of Drug Discovery, will attend the Epigenetic Therapeutic Target Summit, which will be held July 14-15. Dr. Maes will provide a presentation entitled "Pharmaceutical R&D in Epigenetics at Oryzon Genomics" on July 14 at 11:00 CEST while Dr. Soliva will participate in a Panel Discussion entitled "HDAC3, BET, RNA, So Many Targets - Exploring New Potential in Well Known Targets to Create New Value & Diversify Pipelines" taking place on July 14 at 9:30 CEST.
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon's LSD1 program has rendered two compounds, vafidemstat and iadademstat, in Phase II clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurological diseases. Oryzon has offices in Spain and the United States.
Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (See Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A first Phase I/IIa clinical trial with iadademstat in refractory and relapsed acute leukemia patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors, medulloblastoma and others. Iadademstat has been tested in four clinical trials (two in monotherapy in SCLC and AML, and two in combination, in SCLC and AML) in more than 100 patients. In the combination studies, ALICE (ongoing), a Phase IIa trial in combination with azacitidine in elderly or unfit AML patients, and CLEPSIDRA (finalized), a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients, preliminary efficacy results have been reported.
Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer's disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS. A Phase IIb trial in borderline personality disorder (PORTICO) has been recently initiated and the company is preparing a Phase IIb trial in schizophrenia patients (EVOLUTION). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders. Vafidemstat is also being explored in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection.
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