ORYZON Hosting Key Opinion Leader Webinar on Targeting Lysine Specific Demethylase 1 (LSD1) in CNS and Psychiatric Disorders and Oncology

Monday, February 27th at 10am ET

MADRID, Spain and BOSTON, Feb. 22, 2023 (GLOBE NEWSWIRE) -- 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 host a virtual panel discussion, featuring Dr. Dyanna Phillips Domilici (Adams Clinical & Copley Clinical), Dr. med. Peter Hahn (Investigator & Neurology Specialist, emovis), and Dr. Olga Salamero (Vall d’ Hebron University Hospital), discussing the unmet medical needs in specific central nervous system (CNS) and oncology diseases, such as Borderline Personality Disorder, Schizophrenia, and Acute Myeloid Leukemia, along with Oryzon’s therapeutic strategy to treat the underlying causes of these diseases by targeting lysine specific demethylase 1 (LSD1), a key target for epigenetic regulation of gene expression, on Monday, February 27, 2023 at 10:00am Eastern Time.

The event will focus on Oryzon’s Phase 2 programs: vafidemstat, an LSD1 inhibitor optimized for CNS and psychiatric disorders, and iadademstat, a selective LSD1 inhibitor for oncology.

Dr. Dyanna Phillips Domilici is a psychiatrist by training and currently works as a Principal Investigator at Adams Clinical and Copley Clinical, two outpatient clinical research sites in the Greater Boston area that specialize in neurologic and psychiatric drug development. In addition to providing clinical trial oversight, she performs psychological and neurological rating scales for trials in Borderline Personality Disorder, Major Depressive Disorder, Social Anxiety Disorder and Alzheimer’s Disease. Prior to joining Adams Clinical in 2018, Dr. Domilici served as Medical Director for the Inpatient Psychiatric Unit at Beth Israel Deaconess Medical Center in Boston, MA before moving on to start the Psychiatric Consultation Liaison Service at Mass General Brigham’s Newton-Wellesley Hospital in Newton, MA, where she later served as the Associate Chair of Psychiatry from 2014-2017. After completing undergraduate and graduate studies at Johns Hopkins University, she received her MD from the University of South Carolina School of Medicine and is a 2005 graduate of the Harvard Longwood Psychiatric Residency Training Program.

Dr. Peter Hahn attended Medical School Justus-Liebig-University Giessen in Germany from 2009 to 2014. He completed his Residency and Clinic for Psychiatry, followed by his Clinic for Neurology, at the University-Hospital Frankfurt am Main. Since March 2022, he has worked as a specialist in Neurology, and since July 2022 as an Investigator at emovis Gmbh in Berlin, Germany.

Dr. Olga Salamero attended medical school at the Universitat Autònoma de Barcelona, Spain and completed a student fellowship at Saint Thomas University Hospital in London, UK. She specialized in Hematology at Hospital Clinic i Provincial in Barcelona, Spain and obtained the “Emili Letang best resident prize” in Hospital Clinic Barcelona, Spain. She has worked as a hematologist at Vall d’ Hebron University Hospital in Barcelona, Spain since 2010, mainly focused on acute myeloid leukemias. She has been participating in more than 15 clinical trials as PI, with special interest in early-phase clinical trials. She is co-author on more than fifty indexed-publications and is an active member of national hematology societies such as Societat Catalana d’ Hematologia i Hemoteràpia (secretary 2014-2018), CETLAM AML study group (vocal, 2018-now), and PETHEMA AML study group. She was hematology residents mentor between 2012 and 2018 and is also an assistant lecturer in the fourth course at medical school in the Universitat Autònoma de Barcelona.

A live question and answer session will follow the formal presentations. To register for the event, please click here.

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European leader in epigenetics. Oryzon has one of the strongest portfolios in the field, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II clinical trials, and other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com

About Iadademstat
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 FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). In a recently completed Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2022 oral presentation). The company has obtained approval from the U.S. FDA for its IND for FRIDA, a Phase Ib trial of iadademstat plus gilteritinib in patients with relapsed/refractory AML with FLT3 mutations. 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 (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is being evaluated in a collaborative Phase II basket study with the Fox Chase Cancer Center in combination with paclitaxel in R/R neuroendocrine carcinomas, and the company is preparing a new trial in combination in SCLC. Oryzon has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to collaborate on potential further clinical development of iadademstat in different types of solid and hematological cancers. In total iadademstat has been dosed so far to more than 100 cancer patients in four clinical trials. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU.

About Vafidemstat
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, where antiinflammatory activity has also been observed. Vafidemstat has also been tested 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, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Currently, vafidemstat is in two Phase IIb trials in borderline personality disorder (PORTICO) and 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 and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.

FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.