ORYZON Announces Appointment of Douglas V. Faller, MD, PhD as Global Chief Medical Officer and Continues its Expansion of US Corporate Activities

  • Extensive academic and industry experience in hematology/oncology
  • Will coordinate Oryzon’s global clinical development from Boston, USA

MADRID, Spain and CAMBRIDGE, Mass., March 28, 2022 (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 need, announced today the appointment of Douglas Faller, M.D., Ph.D., to the role of Global Chief Medical Officer. Dr. Faller has over 30 years of clinical hematology/oncology expertise and broad drug development experience in the design and execution of early to registrational clinical programs across oncology and rare diseases and will lead Oryzon’s global clinical development strategy. Based in Boston, Dr. Faller will strengthen Oryzon's permanent presence in the US as it builds up strategic partnerships with US hospitals and research institutions to develop its pipeline and clinical programs.

Dr. Faller’s extensive scientific and clinical research experience in hematology and oncology, as well as in other non-oncological and rare diseases, will be key in developing Oryzon’s portfolio. He joins Oryzon from Takeda, where he was Executive Medical Director and Global Clinical Leader for more than 5 years. Dr. Faller holds a medical degree from Harvard University and a Ph.D. in Cancer Molecular Biology from M.I.T. He was Professor of Medicine at Harvard Medical School, and subsequently he founded and served as first Director of Boston University Cancer Center where he was also Grunebaum Professor for Cancer Research, and Professor of Medicine, Biochemistry, Pediatrics, Microbiology, Pathology and Laboratory Medicine. He has founded several biotech companies, some of them currently listed in Nasdaq, and has previously served as the Chief Medical Officer and Chief Scientific Officer of Viracta Therapeutics, Inc (VIRX).

Dr. Carlos Buesa, President and CEO of Oryzon said: “Dr. Faller is an outstanding clinical hematologist and oncologist with a proven track record of driving the design and execution of early, mid- and global late-stage clinical programs. His extensive experience in interactions with US and global regulatory agencies and seniority in oncology development, in both academic and industry settings, will be invaluable as we continue to expand our pipeline. His appointment further reinforces Oryzon’s US footprint as our medical and business operations progressively gravitate towards this major market.”

Dr. Faller said: “With multiple ongoing Phase II trials spanning both oncological and CNS diseases, and with at least two new clinical trials planned to start this year, all utilizing Oryzon’s potentially best-in-class medicines, the company is well positioned to make a meaningful impact in the treatment of some of the most underserved therapeutic areas in cancer and CNS diseases. Our goal is to develop our precision, targeted therapies with iadademstat in oncology, and to pioneer a personalized medicine approach with vafidemstat in neuropsychiatric and neurodevelopmental disorders. I look forward to working with the talented scientists and a dedicated team at Oryzon to advance the corporate mission of helping people with cancers or debilitating CNS disorders to lead longer and better lives."

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European leader in epigenetics. Oryzon has one of the strongest portfolios in the field, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II clinical trials, and other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. 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 FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). In an ongoing Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2021 poster). 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. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). In total iadademstat has been dosed to more than 100 cancer patients in four clinical trials.

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 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, where antiinflammatory activity has also been observed. Vafidemstat has also been tested 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, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Currently, vafidemstat is in two Phase IIb trials in borderline personality disorder (PORTICO) and in schizophrenia patients (EVOLUTION). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders.

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, US IR & Media, Europe Spain Oryzon
Ashley R. Robinson Sandya von der Weid Patricia Cobo Saikat Nandi
LifeSci Advisors, LLC LifeSci Advisors, LLC / Carlos C. Ungría Chief Business Officer
+1 617 430 7577 +41 78 680 05 38 +34 91 564 07 25 +1 917 208 8293
arr@lifesciadvisors.com svonderweid@lifesciadvisors.com pcobo@atrevia.com

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