ORYZON receives the INNOVATIVE SME seal from the Ministry of Science and Innovation
Innovation present in Oryzon's programs in the field of epigenetics acknowledged. The company currently has 2 compounds in Phase II clinical studies, iadademstat and vafidemstat
MADRID, SPAIN and CAMBRIDGE, MA, UNITED STATES, April 19th, 2021 - Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, announces that it has obtained the INNOVATIVE SME seal from the Ministry of Science and Innovation, and has consequently been registered in the Public Registry of INNOVATIVE SMEs.
By awarding this distinction, which aims to reward and highlight the R&D activities of SMEs, the Ministry formally acknowledges the innovative and pioneering nature of Oryzon's studies and clinical advances in the field of epigenetics. This is the third consecutive time that Oryzon receives the INNOVATIVE SME. Oryzon currently has an ongoing Phase IIa clinical trial of iadademstat in combination with azacitidine in patients with Acute Myeloid Leukemia (AML) (ALICE study). Iadademstat is an oral small molecule that acts as a potent and selective inhibitor of the epigenetic enzyme LSD1 (Lysine Specific Demethylase-1) and has a potent differentiating effect in hematological cancers. In the ongoing ALICE study, robust signals of clinical efficacy have been observed, as reported by the company at the American Society of Hematology conference, ASH-2020, with an objective response rate (ORR) of 85%, of which 64% were complete remissions (CR/CRi), and with prolonged response duration, with 86% of CR/CRi with a response duration of more than 6 months and the longest remission of more than 2 years. In addition to the treatment of AML, Oryzon is developing iadademstat for the treatment of small cell lung cancer.
Oryzon is also pioneering the development of LSD1 inhibitors in the field of psychiatric and neurodegenerative diseases. Vafidemstat is an LSD1 inhibitor in Phase II clinical development that has shown a good safety profile and has been shown to be effective in reducing agitation and aggression in clinical studies in patients with Alzheimer's disease, borderline personality disorder (BPD), attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Vafidemstat is currently being explored in two Phase IIb clinical trials, one in BPD and the other in severe patients with Covid-19, and the company is preparing an additional Phase IIb clinical trial with vafidemstat in schizophrenia. Oryzon is also a pioneer in the field of precision medicine in psychiatry, where it is exploring vafidemstat as a potential treatment for certain psychiatric diseases harboring mutations in certain genes that have been shown to be amenable to treatment with LSD1 inhibitors.
Ashley R. Robinson
LifeSci Advisors, LLC
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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 https://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 preliminary 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 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 authorized and the company is preparing a Phase IIb trial in schizophrenia patients (EVOLUTION). 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.