ORYZON Awarded EU Grant to Further Explore the Role of Iadademstat in Oncological Immunotherapy Approaches

• Eurostars-3 collaborative project with Danish institutions ImProTher and University of Copenhagen

• Global budget of 1.4 million euros; Oryzon to receive up to 400,000 euros

• Project will assess the efficacy of iadademstat in combination with checkpoint inhibitors and/or oncological vaccines
  

MADRID, Spain and BOSTON, Dec. 16, 2022 (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 the approval by the EU-intergovernmental organization EUREKA secretariat of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) under the Eurostars-3 program. This project will be developed in collaboration with two European partners: the Danish company ImProTher and the University of Copenhagen, and will evaluate the role of iadademstat in several immunotherapy strategies, including checkpoint inhibitors and/or oncological vaccines, in solid tumors.

The project will start on May 1, 2023 and will run for two years. The project has a global budget of 1.4 million euros, with Oryzon contributing approximately with 50%.

Dr Jordi Xaus, Oryzon’s Chief Scientific Officer said: “Checkpoint inhibitors are being explored in therapeutic combinations as an alternative in those solid tumors which are recalcitrant to chemotherapy or only showing limited responsiveness. New oncological targeted vaccines promise to be part of a new generation of immunotherapy weapons in the field. However, both strategies require effective immune presentation of antigens by the tumoral cells, and several tumors evade this requirement, acting as the so-called cold tumors. Iadademstat is an LSD1 inhibitor that has been shown to boost immune response and could provide additional efficacy in these combinations, transforming these tumors in better recognized targets for the immunotherapies.”

Iadademstat is an orally active, highly potent, and selective inhibitor of the epigenetic enzyme LSD1, currently under clinical development for the treatment of hematologic cancers and certain solid tumors. In a recently completed Phase IIa study (ALICE trial) in elder/unfit acute myeloid leukemia (AML) patients sponsored by Oryzon, iadademstat demonstrated robust efficacy in combination with azacitidine, with 81% ORR in the evaluable patients, of which 64% were CR/CRi. Final data were presented as an oral communication at the 64th ASH annual conference earlier this week (see here for more details). The company is now initiating an FDA-approved Phase Ib trial (FRIDA trial, NCT05546580) of iadademstat in combination with gilteritinib in FLT3-mutant relapsed/refractory AML patients and is preparing a new Phase Ib/II trial (STELLAR trial) of iadademstat in combination with immune checkpoint inhibitors in small cell lung cancer (SCLC). Iadademstat’s antitumoral efficacy is also being explored in a collaborative Phase II basket study (NCT05420636) with the Fox Chase Cancer Center as the sponsor, with Dr. Namrata Vijayvergia, MD, Associate Professor and member of the Cancer Epigenetics Institute at Fox Chase Cancer Center, as the principal investigator. This trial will assess the safety and efficacy of iadademstat in combination with paclitaxel in patients with relapsed/refractory SCLC or extrapulmonary high grade neuroendocrine carcinomas. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU.