ORYZON to give updates on corporate progress in September
- H.C. Wainwright Global Investment Conference in NYC
- Sachs Annual Biotech in Europe Forum in Basel
- Third Annual Global CMT Research Convention in Boston
- BioSpain-2023 in Barcelona
MADRID, SPAIN and BOSTON, MA, UNITED STATES, September 5th, 2023 - 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 its management will give an update on corporate progress at several international events in September.
Oryzon will participate at the H.C. Wainwright Global Investment Conference, which will be held on September 11-13 at the Lotte New York Palace Hotel in New York (USA) and virtually. The company will provide a corporate update and will also hold one-on-one meetings with pharmaceutical companies and global investors. Click on link for more info about the H.C. Wainwright Global Investment Conference
Oryzon has been invited to the Sachs Annual Biotech in Europe Forum in Basel (Switzerland) on September 20-21, where the company will participate in a panel entitled “Advanced Approaches to Neurodegenerative Diseases Panel”, which will be held on September 20. The company will also hold one-to-one meetings with pharmaceutical companies and global investors. Click on link for more info about the Sachs Annual Biotech in Europe Forum
Oryzon will attend the Third Annual Global Charcot Marie-Tooth (CMT) Research Convention in Cambridge, MA on September 22-23, where Oryzon’s Chief Medical Officer, Dr. Douglas V. Faller, will participate in a round table entitled “Pushing Boundaries in CMT Research: Early-Stage Biotech Companies' Evolution and Insights on Therapy Development” and our Oncology Project Leader Dr. Natalia Sacilotto will take part in a round table entitled “Patient-Powered Perspectives: Biotech Insights on CMT and Collaborating with Patients”. Additionally, the company will present during the poster session the data obtained in a CMT experimental model with its selective HDAC6 inhibitor ORY-4001. Click on link for more info about the Global CMT Research convention
Executive directors of the company will attend BIO-Spain 2023, which will take place on September 26-28 in Barcelona, Spain. Besides regular one-on-one meetings, the company will moderate a KOL panel discussion focused on mental health and precision medicine and the potential of LSD1 inhibitors like vafidemstat. This panel, entitled “Mental Health and Personalized Medicine”, will take place on September 26 at 16:00-17:00 h CET, and will be chaired by Dr. Tamara Maes, Oryzon’s VicePresident, with the participation of Dr. Marc Ferrer, MD, PhD, Coordinator of the Comprehensive Care Program for Borderline Personality Disorder (BPD) for adolescents and young adults at the Vall d’Hebron University Hospital (Spain), Dr. Clara Tang, Director of Research at the Kabuki Syndrome Foundation (UK) and Dr. Siddharth Banka, MBBS, MRCPCH, PhD, Manchester Centre for Genomic Medicine (Manchester University NHS Trust). The company will also participate in a KOL panel discussion moderated by Mr. Jesús González Nieto-Márquez, Managing Director of BME, entitled “Want to be a “Rocket”? How stock markets boost the growth of biotech companies” with the participation of Mr. Roger Freixes, Partner of Cuatrecasas (Spain); Dr. Isabel Lozano, CEO of Atrys (Spain) and Dr. Carlos Buesa, CEO of Oryzon (Spain). This panel will take place on September 27 at 17:30-18:30 h CET. Click on link for more info about BIO-Spain
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, NYC and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has 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
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 anti-inflammatory 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.
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). Iadademstat is currently being evaluated in combination with gilteritinib in the Phase Ib FRIDA trial 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.
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.