ORYZON Presents New Efficacy Data From its Phase II Trial ALICE Investigating iadademstat in AML

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

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 neurodegenerative 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).

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