• To present at upcoming international conference
    - ESMO-2019 in Barcelona, Spain
    - 19th Annual Biotech in Europe Investment Forum in Basel, Switzerland
    - 4th Annual MarketsandMarkets Epigenetics Congress in London, UK
    - CINP 2019 in Athens, Greece
  • Announces extension of clinical trials
    - Extension of duration of SATEEN study in Secondary Progressive Multiple Sclerosis
    - Extension of duration of REIMAGINE-AD in aggressiveness in moderate-severe Alzheimer’s

MADRID, Spain and CAMBRIDGE, Mass., Sept. 23, 2019 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical needs, announced today that Executive Directors of the company will present at several reputed international conferences in the next few weeks.

Oryzon will present additional data from CLEPSIDRA, a Phase II trial in relapsing small cell lung cancer (SCLC) patients treated with the epigenetic drug iadademstat in combination with SoC, at the European Society for Medical Oncology Conference (ESMO 2019) that will be held from September 27 to October 1 in Barcelona, Spain. The company will present a poster entitled “CLEPSIDRA: a pilot, biomarker-guided study to assess safety, tolerability, dose finding and efficacy of iadademstat in combination with platinum-etoposide in patients with relapsed, extensive-stage small cell lung cancer.” For more info about this conference, please visit https://www.esmo.org/Conferences/ESMO-Congress-2019

Dr. Carlos Buesa and Dr. Roger Bullock, Oryzon’s CEO and CMO respectively, will attend the 19th Annual Biotech in Europe Forum. This event will take place on September 25-26 at the Congress Center in Basel (Switzerland). Dr. Buesa will deliver a corporate presentation on September 25 14:15 CET. Dr. Bullock will take part as a panelist in the Neuroscience II - Development & Partnering Panel, which will be co-chaired by Dr. Greg McDonald, Senior Director, Neuroscience Scientific Licensing, Johnson and Johnson, and Dr. Charles Bailey, Head, Neuroscience BD & Licensing, Novartis.

Dr. Tamara Maes, Oryzon’s CSO, will attend the 4th Annual MarketsandMarkets Epigenetics Congress, to be held on October 3-4 in London, United Kingdom. Dr. Maes will deliver an oral presentation entitled “LSD1 inhibitors Iadademstat and Vafidemstat from bench to bedside” on October 4 10:00 local time. For more information about this congress please visit: https://plg-group.com/events/xvipls/

Finally, the company will present additional safety and clinical efficacy data of the epigenetic drug vafidemstat in patients with borderline personality disorder (BPD), attention deficit and hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) from the Phase IIa REIMAGINE basket trial at the International Conference on Neuropsychopharmacology, CINP 2019, to be held on October 3-5 in Athens, Greece. Jordi Xaus, Portfolio Director at Oryzon, will present a poster entitled:” Vafidemstat: An epigenetic drug with emerging therapeutic potential, composite data from three psychiatric disorders from the REIMAGINE trial”. For more info about this conference, please visit https://cinp2019.org/

The company further announced today that the duration of several ongoing clinical trials has been extended. In particular, in SATEEN, a pilot Phase IIa clinical trial evaluating vafidemstat in multiple sclerosis, where patients are treated with vafidemstat or placebo for 9 months under double blind followed by an open label extension period of 6 months where all patients are treated with vafidemstat, the extension phase in patients with the secondary progressive form of the disease has been extended from 6 months up to a maximum of 18 months of vafidemstat treatment to allow to assess the effect of vafidemstat as a therapeutic treatment for the progressive form of the disease which requires longer clinical observation periods. This protocol amendment has been approved by the Spanish Medicines Agency. The company will inform in due time in which medical conferences will present data from this study.

Moreover, in REIMAGINE-AD, a Phase IIa study to assess the effect of vafidemstat in aggressiveness in moderate and severe Alzheimer’s patients, following the recommendation of the clinical investigators, the trial has been extended from 2 to 6 months to allow a better evaluation not only of the potential effect of vafidemstat on aggressiveness but also on other core features of the disease that are present in this advanced stage of the disease. This protocol amendment has been approved by the Spanish Medicines Agency. As a consequence of this extension the company now plans to present results from REIMAGINE-AD at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-ADPD 2020 meeting, to be held on April 2-5 2020 in Vienna, Austria.

About Oryzon
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 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 neurodegenerative diseases. Oryzon has offices in Spain and the United States. 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 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), medulloblastoma and others. Oryzon is conducting two Phase IIa clinical trials of iadademstat in combination; the first one in combination with azacitidine in elderly AML patients (ALICE study) and the second one in combination with platinum/etoposide in second line SCLC patients (CLEPSIDRA study).

About Vafidemstat
Vafidemstat (ORY-2001) is an oral, brain penetrant drug that selectively inhibits LSD1 and MAOB. 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, 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). Vafidemstat is in Phase IIa clinical studies in patients with Relapse-Remitting and Secondary Progressive MS (SATEEN), in patients with Mild to Moderate Alzheimer’s disease (ETHERAL) and in aggressiveness in patients with different psychiatric or neurodegenerative disorders (REIMAGINE and REIMAGINE-AD).

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.

IR & Media, US & Europe:Spain:Oryzon:
LifeSci Advisors LLC ATREVIAEmili Torrell
Hans HerklotsPatricia Cobo/Idoia RevueltaBD Director
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etorrell@oryzon.com