Etoposide

Key combination for the treatment of first-line AML Recent data from an ongoing study in first-line AML showed a 100% overall response rate (ORR) with iadademstat in combination with venetoclax and azacitidine MADRID and CAMBRIDGE, Mass., March 23, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. patent US12,564,559 B2, relating to therapeutic combinations of iadademstat, Oryzon’s potent and selective LSD1 inhibitor currently in clinical development in oncology and hematology. The granted patent includes claims covering methods of treating neoplastic diseases, including acute myeloid leukemia (AML), using combinations comprising iadademstat and other therapeutic agents, notably including venetoclax, a backbone therapy in the current standard of care for first-line acute myeloid leukemia. The patent is expected to expire in January 2039, including 681 days of patent term adjustment (PTA) granted by the USPTO to compensate for delays during patent prosecution. This does not include any potential patent term extension related to regulatory review, which could further extend the patent term. Iadademstat is currently being evaluated in seven ongoing oncology clinical trials, including the Phase Ib ALICE-2 study in first-line AML in combination with venetoclax and azacitidine. Highly encouraging preliminary data from this trial were presented at the American Society of Hematology (ASH) 2025 Annual Meeting, showing a 100% overall response rate (ORR) and a 90% strict complete remission (CR) rate. The trial continues to enroll rapidly, and updated data from approximately 15-16 patients (around 75% of the planned enrollment), are expected to be presented at the European Hematology Association Annual Congress (EHA) in June 2026. “This U.S. patent grant represents a significant addition to our growing IP portfolio for iadademstat,” said Neus Virgili, Oryzon’s Chief IP Officer. “This patent covers combinations with venetoclax, the current standard of care in first-line AML, and provides protection extending into 2039, strengthening the long-term value of our clinical programs.” In addition to this U.S. patent, Oryzon has obtained patent protection for combinations of iadademstat with venetoclax, or their use in the treatment of cancer, in Australia, Brazil, Canada, Europe, India, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, and Russia. Additional patent applications are pending in other jurisdictions. Oryzon also holds granted patents covering combinations of iadademstat with other AML therapies, including azacitidine and decitabine, in the United States and other countries. About Oryzon Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, with several ongoing Phase I and II studies and outstanding preliminary results in first-line acute myeloid leukemia, including a 100% overall response rate (ORR) presented at ASH 2025; and vafidemstat, its lead CNS program, which is Phase III–ready. In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which a clinical candidate, ORY-4001, has been nominated for potential development in Charcot–Marie–Tooth disease (CMT) and amyotrophic lateral sclerosis (ALS). The Company also operates a robust platform for biomarker identification and target validation across a range of malignant and neurological diseases. For more information, visit 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). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study (IIS) led by OHSU and in combination with gilteritinib in the company-sponsored Phase Ib FRIDA trial in relapsed/refractory FLT3-mutant AML, with highly encouraging preliminary safety and efficacy data recently reported at ASH-2025 for both trials: 100% ORR and 90% strict CR in 1L AML, and 67% CCR (at the dose under expansion) in R/R AML. Additional studies in hemato-oncology include an IIS in MDS, and trials in myeloproliferative neoplasms and 1L AML both sponsored and conducted by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI. 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 (NET), 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). Iadademstat is in two trials in ED-SCLC: a Phase I/II randomized trial in 1L in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center, and an IIS trial in 1L/2L in combination with ICI and radiotherapy. In addition, Oryzon has expanded iadademstat’s clinical development into non-oncological hematology indications, with trials in sickle cell disease (approved by EMA, enrolling) and essential thrombocythemia (approved by EMA). Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. FORWARD-LOOKING STATEMENTS 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 document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration.. Spain Oryzon IR & Media, Europe & US Patricia Cobo/Mario Cordera Emili Torrell Sandya von der Weid Atrevia Chief BD Officer LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com svonderweid@lifesciadvisors.com

March 17, 2026 -- Pharmacosmos today announced the initiation of a phase III, randomised, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy and safety of trilaciclib in participants with limited-stage small cell lung cancer. The study is being conducted at clinical sites in the United States, EU and the United Kingdom. The trial will compare trilaciclib with placebo when administered prior to standard chemoradiotherapy and is designed to assess whether trilaciclib can reduce chemotherapy-induced myelosuppression and improve treatment tolerability in patients with limited-stage small cell lung cancer. Trilaciclib is currently approved and marketed in the United States for use prior to platinum/etoposide-containing or topotecan-containing regimens in adults with extensive-stage small cell lung cancer, where it is indicated to decrease the incidence of chemotherapy-induced myelosuppression. Limited-stage small cell lung cancer represents an earlier stage of the disease, in which the cancer is confined to one side of the chest and treatment is typically delivered with curative intent using concurrent chemotherapy and radiation (chemoradiotherapy). As with extensive-stage disease, treatment of limited-stage disease is associated with chemotherapy-induced myelosuppression, which can lead to dose reductions, treatment delays and an increased risk of complications. Chemotherapy-induced myelosuppression is traditionally managed once it occurs. The study evaluates a novel approach in which bone marrow protection is administered prior to chemotherapy. Trilaciclib is a short-acting CDK4/6 inhibitor administered intravenously prior to chemotherapy. By transiently inducing cell-cycle arrest in haematopoietic stem and progenitor cells, trilaciclib is designed to protect all blood cell lineages from chemotherapy-induced damage. “With this phase III study, we are extending the clinical development of trilaciclib into limited-stage small cell lung cancer,” said Lars Lykke Thomsen, Executive Vice President and Chief Medical Officer at Pharmacosmos. “We look forward to evaluating the role of bone marrow protection with trilaciclib in patients with limited-stage small cell lung cancer receiving intensive chemoradiotherapy.” Pharmacosmos has submitted regulatory applications for trilaciclib in extensive-stage small cell lung cancer outside the United States. The phase III study is a randomised, double-blind, placebo-controlled, multicentre trial conducted in the United States, EU and the United Kingdom evaluating trilaciclib administered prior to standard chemoradiotherapy in participants with limited-stage small cell lung cancer. The study will assess efficacy and safety endpoints related to chemotherapy-induced myelosuppression and overall treatment tolerability. Trilaciclib is an intravenous CDK4/6 inhibitor designed to be administered prior to chemotherapy to protect bone marrow function. It is approved in the United States for use in adults receiving a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, Canada, the USA, and China. The content above comes from the network. if any infringement, please contact us to modify.