Precision in Drug Discovery & Preclinical Virtual Summit
European Hematology Association (EHA) 2021 Congress
BIO International Convention 2021
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 May and June, all to be held virtually.
Dr. Carlos Buesa, Oryzon’s CEO, together with Dr. Torsten Hoffmann, CSO, Dr. Jordi Xaus, Vice President of Clinical Portfolio and Innovation, and Emili Torrell, BDO, will attend BioEquity Europe Digital, which will be held on May 17-19. Dr. Buesa will present a corporate update and together with his team will hold 1x1 meetings with international investors and pharma industry professionals. For more info about this event, please visit: https://conferences.biocentury.com/bioequity-europe
Dr. Hoffmann will attend the Oxford Global’s Online Drug Discovery Week, which will take place on June 1-4, where he will give a presentation entitled “Pharmaceutical R&D in Epigenetics at Oryzon Genomics”, on June 1 at 14:30 CEST. For more info about this event, please visit: https://www.oxfordglobal.co.uk/discovery-online/
Dr. Buesa will also attend the Jefferies Virtual Healthcare Conference, which will be held June 1-4. Dr. Buesa will hold 1x1 meetings with international investors and pharma industry professionals and will also present a corporate update on June 4 at 09:00 EST. For more info about this event, please visit: https://www.jefferies.com/IdeasAndPerspectives/Conferences/325/060821
The company will present a clinical update of the ongoing iadademstat’s ALICE Phase II trial in acute myeloid leukemia (AML) at the European Hematology Association (EHA) 2021 congress, which will be held June 10-13. This clinical update will be presented as an e-poster entitled “ALICE maintains high clinical response rates supporting the efficacy of iadademstat combination with azacitidine in AML management”, available through the on-demand virtual congress platform as of June 11 at 09:00 CEST. ALICE is a single arm, open-label Phase IIa clinical trial evaluating the safety, tolerability, dose finding and efficacy of iadademstat in combination with azacitidine in older patients with AML in first line therapy. In accordance with the embargo terms and conditions for presentation at the EHA Congress, data will be released on the same day as the communication, June 11. For more info about EHA-2021, please visit: https://ehaweb.org/congress/eha-congress-2021/key-information/
Finally, Dr. Buesa, and Mr. Torrell will attend the Bio International Convention 2021, which will be held June 14-18. Dr. Buesa will present a corporate update and, together with his team, will hold 1x1 meetings with international investors and pharma industry professionals. For more info about this event, please visit: https://www.bio.org/events/bio-digital
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. Oryzon is one of the most liquid biotech stocks in Europe with +90 M shares negotiated in 2020 (ORY:SM / ORY.MC / ORYZF US OTC mkt). For more information, visit www.oryzon.com
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 certain genetically defined patient populations. 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.
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.