ORYZON Presents New Efficacy Data From its Phase II Trial ALICE Investigating iadademstat in AML
- Results presented at 61st ASH Annual Conference in Orlando, FL, USA
- Signals of clinical efficacy continue to be encouraging, with 75% OR (6 out of 8: 2 CR, 3 CRi and 1 PR)
- Rapid clinical responses (mean time to first response is currently 32 days)
- Preliminary rate of conversion to red cell Transfusion Independence (40%) is also encouraging
- Safe and well tolerated, with no clinically relevant non-hematological AEs
MADRID, Spain and CAMBRIDGE, Mass., Dec. 09, 2019 (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, today presented new data from its ongoing Phase II trial ALICE, which is investigating iadademstat in combination with azacitidine in elderly patients with acute myeloid leukemia (AML). The data were presented at the ongoing 61st ASH Annual Meeting and Exposition in Orlando, FL, USA in the form of a poster entitled “Iadademstat Shows Efficacy in Elderly AML Patients in Combination with Azacitidine. ALICE Trial”.
To date 13 patients have been enrolled in this trial. As reported previously at the European Hematology Association (EHA) meeting, the combination of iadademstat with azacitidine continues to show a good safety profile in elderly AML patients. Due to the well characterized full target engagement, the initial recommended dose has been adjusted to improve tolerability and adherence. Besides the reported hematological events, the combination appears to be safe and well tolerated, with no clinically relevant non-hematological adverse events reported to date.
The growing evidence of clinical efficacy is also encouraging, with 6 of the 8 evaluable patients (75%) achieving objective responses (OR): of these there were 2 complete remissions (CR), 3 complete remissions with incomplete hematologic recovery (CRi) and 1 partial remission (PR). The mean follow up time amongst the evaluable patients was 20 weeks, with a mean Time to Response (TTR) of only 32 days in those patients who responded. Two of the 5 patients (40%) that have received more than 3 cycles of treatment have also become transfusion independent (i.e. not requiring subsequent red cell transfusions). With historical response rates of 27% in this population when treated with azacitidine alone, the current results are supportive for a significant synergistic effect from iadademstat.
The objective of the ALICE trial is to provide information that will inform the broader application of iadademstat in other leukemias. It is designed as a single-arm, open-label study of iadademstat in combination with the standard of care treatment azacitidine in newly diagnosed elderly AML patients and is being carried out in several Spanish hospitals. The study is divided into two parts, the first optimizing the dose of the combination, and the second evaluating the combination’s effectiveness. The study will recruit up to 36 patients. Efficacy endpoints include clinical response, as well as time to response, duration of response and average survival.
Dr. Carlos Buesa, Oryzon’s CEO, said: "We are pleased with these new data which show a growing number of patients responding to iadademstat. The current results, so far, compare well with the most recent standard of care combination therapies for this type of elderly AML patient. If confirmed as this study progresses, they have the potential to open new scenarios for our company in the development of this molecule.”
A copy of the poster is available here
For more information about this event, please visit ASH website
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 neurodegenerative diseases. Oryzon has offices in Spain and the United States. 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), 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).
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.
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