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 62^nd 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 20^th. 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.

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