ORYZON to Present Further Positive Efficacy Data From Iadademstat ALICE Phase IIa Trial at the 62nd Congress of the American Society of Hematology

MADRID, Spain and CAMBRIDGE, Mass., Nov. 11, 2020 (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 the company will present additional preliminary safety and efficacy data from one of its ongoing Phase IIa clinical trials with iadademstat, ALICE, at the 62nd American Society of Hematology Conference, ASH 2020, to be held virtually on December 5-8.

The company will present an e-poster entitled “Robust Efficacy Signals in Elderly AML Patients Treated with Iadademstat in Combination with Azacitidine (ALICE Phase IIa Trial)l”, which will be available through the on-demand Virtual Congress platform as of Sunday, December 6, 07:00 am PT. In accordance with the embargo terms and conditions for presentation at ASH, data will be released on the same day as the e-poster. The abstract can be visited at https://ash.confex.com/ash/2020/webprogram/Paper134310.html 

ALICE ("An AML trial with LSD1i in Combination with azacitidine in the Elderly") is a single arm, open-label Phase IIa clinical trial to evaluate the safety, tolerability, dose finding and efficacy of iadademstat in combination with azacitidine in older patients with Acute Myeloid Leukemia (AML) in first line therapy.

Dr. Carlos Buesa, Oryzon’s CEO, will present at Jefferies 2020 Virtual London Healthcare Conference, to be held on November 17-19. Oryzon’s video presentation will take place Wednesday, November 18, at 12:20 pm GMT. The company will also hold one-on-one meetings with other pharmaceutical companies, investors and analysts. See more info at https://www.jefferies.com/OurFirm/Conferences/325/.

Additionally, the company will participate in the virtual Borderline Personality Disorder Day organized by the Spanish BPD Association, AMAI-TLP on November 20th. Dr. Buesa will participate in an Expert’s Panel with a talk entitled “Vafidemstat in personalized medicine for CNS: epigenetic keys for the treatment of BPD and other psychiatric diseases”.

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 neurological 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). In both studies, preliminary clinical results have been reported.

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 a Phase IIa clinical trial in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive preliminary clinical results reported. Additional Phase IIa clinical trials with vafidemstat are ongoing in patients with Mild to Moderate AD (ETHERAL), where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 months of treatment, and in Relapse-Remitting and Secondary Progressive MS (SATEEN). A phase IIB in BPD patients has been recently initiated. Vafidemstat is also being explored in a Phase II in severe Covid-19 patients assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection.

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 ATREVIA Emili Torrell
Mary-Ann Chang Patricia Cobo/Carlos C. Ungría BD Director
+44 7483 284853 +34 91 564 07 25 +34 93 515 13 13
mchang@lifesciadvisors.com pcobo@atrevia.com
cungria@atrevia.com
etorrell@oryzon.com

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