RegulationConditional marketing approval (CN), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP), Special Review Project (CN), Priority Review (AU), Fast Track (US)

Structure

Molecular FormulaC29H44N8O3

InChIKeyGYQYAJJFPNQOOW-UHFFFAOYSA-N

CAS Registry1254053-43-4

View All Structures (2)

Clinical Trials associated with Gilteritinib Fumarate

NCT06667973 / Not yet recruitingPhase 2IIT

A Phase 2, Open-label, Multicentre Study Investigating Tolerability and Efficacy of Gilteritinib in Combination With Fludarabine, Cytarabine and Idarubicin (FLAI) as Induction Therapy of Newly Diagnosed Non-M3 FLT3-positive Acute Myeloid Leukemia

The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is:
Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML?
Participants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.

Start Date01 Mar 2025

Sponsor / Collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

NCT06561880 / Not yet recruitingPhase 1/2IIT

A Multi-center, Single-arm Trial of the Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation

The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal dosage of the triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients. Besides, this trial will provide evidence for treatment decisions based on measurable residual disease in patients with the triple regimen.

Start Date01 Oct 2024

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

NCT06317649 / RecruitingPhase 2IIT

A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

Start Date27 Sep 2024

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Gilteritinib Fumarate

100 Translational Medicine associated with Gilteritinib Fumarate

100 Patents (Medical) associated with Gilteritinib Fumarate

381

Literatures (Medical) associated with Gilteritinib Fumarate

31 Dec 2024·Hematology

Effective treatment with Gilteritinib-based regimens for FLT3-mutant extramedullary relapse in acute promyelocytic leukemia

Article

Author: Hou, Chun-Xiao ; Chen, Su-Ning ; Jiang, Yi-Zhi ; Huang, Dong-Ping ; Chen, Yu ; Liu, Shan-Hao

OBJECTIVEExtramedullary relapse (EMR) is rare in acute promyelocytic leukemia (APL) and, there is a lack of information on its management. Current practices for EMR in APL are always to adopt strategies from other subtypes of Acute lymphoblastic leukemia (ALL) and Acute myeloid leukemia (AML). Gilteritinib, a highly selective FLT3 inhibitor, has demonstrated a remarkable effect on EMR in FLT3-mutant AML. Therefore, it is worthwhile exploring if FLT3 mutation can be a therapeutic target and assessing the efficacy of Gilteritinib on FLT3-mutant EMR in APL.METHODSWe described three cases of FLT3-mutant EMR in APL, comprising two isolated EMR cases and one systemic relapse. The patients underwent treatment with Gilteritinib-based regimens based on FLT3 mutation.RESULTSAll three patients achieved complete regression of EMR, and no signs of tumor lysis syndrome during Gilteritinib-based therapy, only patient 1 showed mild granulocytopenia. They all maintained molecular complete remission (mCR) during the follow-up period.CONCLUSIONSThe Gilteritinib-based regimen shows a high and sustained therapeutic effect with minimal adverse effects, and provides a valuable experience for further evaluation in EMR APL patients.

31 Dec 2024·Hematology

Sweet syndrome induced by FLT3 inhibitors: case report and literature review

Review

Author: Zhang, Ran ; Ma, Hongbing ; Yang, Linhui

BACKGROUNDAcute febrile neutrophilic dermatosis, also commonly referred to as Sweet syndrome, is often associated with tumors, infections, immune disorders and medications. FLT3 inhibitor-induced Sweet syndrome is a rare complication.METHODS AND RESULTSWe report a patient with relapsed and refractory acute monocytic leukemia harboring high-frequency FLT3-ITD and DNMT3a mutations. The FLT3 inhibitor gilteritinib was administered for reinduction therapy after failure of chemotherapy with a combination of venetoclax, decitabine, aclarubicin, cytarabine and granulocyte colony-stimulating factor. The leukemia patient achieved remission after 1 month of treatment. However, Sweet syndrome induced by gilteritinib, which was confirmed by skin biopsy, developed during induction therapy. Similar cases of Sweet syndrome following FLT3 inhibitor therapy for acute myeloid leukemia were reviewed.CONCLUSIONAttention should be given to this rare complication when FLT3 inhibitors are used for acute myeloid leukemia therapy, and appropriate treatments need to be administered in a timely manner.

31 Dec 2024·Future Science OA

SARS-CoV-2-induced phosphorylation and its pharmacotherapy backed by artificial intelligence and machine learning

Article

Author: Qamar, Fouzia ; Idrees, Jawaria ; Salman, Saad ; Haider, Sana ; Wasim, Asif ; Sharif, Zubair

Aims: To investigate the role of phosphorylation in SARS-CoV-2 infection, potential therapeutic targets and its harmful genetic sequences. Materials & Methods: Data mining techniques were employed to identify upregulated kinases responsible for proteomic changes induced by SARS-CoV-2. Spike and nucleocapsid proteins' sequences were analyzed using predictive tools, including SNAP2, MutPred2, PhD-SNP, SNPs&Go, MetaSNP, Predict-SNP and PolyPhen-2. Missense variants were identified using ensemble-based algorithms and homology/structure-based models like SIFT, PROVEAN, Predict-SNP and MutPred-2. Results: Eight missense variants were identified in viral sequences. Four damaging variants were found, with SNPs&Go and PolyPhen-2. Promising therapeutic candidates, including gilteritinib, pictilisib, sorafenib, RO5126766 and omipalisib, were identified. Conclusion: This research offers insights into SARS-CoV-2 pathogenicity, highlighting potential treatments and harmful variants in viral proteins.

113

News (Medical) associated with Gilteritinib Fumarate

24 Oct 2024

·www.biospace.com

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024

Final data from PORTICO, global Phase IIb vafidemstat trial in BPD, presented at the 37th ECNP annual conference in September Company moving forward with PORTICO-2 Phase III trial preparations following positive feedback from End-of-Phase II meeting with the FDA Company continues to strengthen IP position for vafidemstat with additional “intention to grant” communications First cohort dosed in Investigator-initiated Phase Ib study of iadademstat with venetoclax and azacitidine in first-line AML Reduction in R&D expenses for the nine months ended September 30, 2024 as a result of completion of the PORTICO clinical trial; savings of $5.1M with respect to the nine months ended September 30, 2023 MADRID and CAMBRIDGE, Mass., Oct. 24, 2024 (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, today reported financial results for the nine months ending September 30, 2024 and provided a corporate update on recent developments. Dr Carlos Buesa, Oryzon’s Chief Executive Officer said, “This quarter marked a pivotal moment for our CNS program. At the ECNP 2024 Conference, we presented the full dataset from our Phase IIb PORTICO trial of vafidemstat for Borderline Personality Disorder (BPD), and we observed notable improvements across most study endpoints compared to the topline data released in January. We also received the official minutes from our End-of-Phase II meeting with the FDA, confirming that we can proceed to a Phase III. The FDA indicated that agitation/aggression in BPD may be an acceptable indication, and agreed that we may use the same aggression scale that showed the strongest signal in Phase II. With this positive feedback, we will now begin preparations to submit the full Phase III protocol to the FDA. Careful analysis of the effect sizes in BPD has allowed us to reevaluate and increase the recruitment target for the EVOLUTION trial in schizophrenia, which continues to enroll patients in Spain. Meanwhile, we have strengthened our CNS intellectual property portfolio with additional “intention to grant” communications in two key patent families covering the use of vafidemstat in treating aggression, social withdrawal and BPD. These advancements significantly bolster our IP position for vafidemstat.” Dr Buesa continued, “In oncology, following the very positive results of our ALICE trial with iadademstat in first-line unfit AML patients, we are expanding our efforts to further evaluate therapeutic efficacy in this patient population through two additional trials. One is conducted under our CRADA agreement with the NCI, while the other is in collaboration with Oregon Health & Science University (OHSU) as an investigator-initiated study (IIS). Both trials will assess iadademstat in combination with azacitidine and venetoclax in first-line AML. The OHSU-led IIS trial has already enrolled the first cohort, representing a significant advancement in our oncology program and, if positive, could open additional options for our clinical development strategy. In addition, a new IIS sponsored by the Medical College Wisconsin in combination with azacitidine in patients with myelodysplastic syndrome is being prepared. In June, we presented promising initial data from our ongoing FRIDA Phase Ib trial, evaluating iadademstat in combination with gilteritinib in relapsed/refractory FLT3-mutant AML patients, at the EHA Conference. The data from the first two cohorts demonstrated that the combination was safe and showed strong antileukemic activity, with encouraging response rates and a shorter time to response compared to historical data on gilteritinib alone. We have since completed enrollment of the third cohort, and as the data matures, we plan to present additional results at the EHA Conference next June.” Dr Buesa added, “The positive outcome of the End-of-Phase II meeting with the FDA has been a turning point for the company, as it transitions into a Phase III company for the first time. While we remain committed to maintaining strict budgetary discipline and leveraging access to our Convertible Notes program, we anticipate receiving further financial support from the recently approved IPCEI grant from the EU, which will provide crucial resources to advance our R&D in personalized medicine for both CNS and oncology. The company is also actively engaged in discussions with corporate partners to explore potential partnerships and will continue evaluating additional financing opportunities.” Third Quarter and Recent Highlights Vafidemstat in large multifactorial CNS indications: Final data from vafidemstat’s Phase IIb PORTICO trial in BPD were presented at the New Medications Symposium, a special symposium focused on clinical trials of new compounds within the 37th European College of Neuropsychopharmacology (ECNP-2024) congress held in September in Milan, Italy. A strong improvement in State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger, a measure of agitation and aggression, at Weeks 8–12 was observed compared to previous top line data (TLD); nominal statistical significance now of p = 0.0071 (previously 0.0259). An improvement in Borderline Evaluation of Severity (BEST), an overall measure of BPD disease severity, at Weeks 8–12 compared to TLD was also achieved; nominal statistical significance now of p = 0.0260 (previously 0.0423). Vafidemstat showed favorable results over placebo in all primary and secondary efficacy endpoints, as demonstrated by T-Forest plot analysis. The final analysis confirmed now a global treatment effect favoring vafidemstat by the Global Statistical Test (GST), with the GST p-value showing a statistical significance, particularly when considering global improvement in the severity of the disease and in agitation/aggression (p = 0.0362). Vafidemstat was, as in all previous clinical studies, safe and well-tolerated. Oryzon has received the minutes from the end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA). Based on the positive feedback received, ORYZON has started preparations for Phase III, including the preparation of a full protocol for the PORTICO-2 Phase III trial to submit to the FDA for study approval. The trial will use STAXI-2 Trait anger as a primary efficacy endpoint measure. Secondary endpoints will include both patient-rated and clinician-rated scales, such as CGI-S A/A to assess agitation/aggression, and BEST and CGI-S to assess overall BPD improvement.The estimated total sample size for PORTICO-2 is 350 patients (randomized 1:1 vafidemstat or control), with a trial duration of 18 weeks in total. Subject to FDA’s review of the final data, the PORTICO-2 Phase III study has the potential to be one of the two registrational trials required by the FDA. The company expects to obtain FDA’s approval for PORTICO-2 by end of 1Q2025. Oryzon has continued to strengthen its patent portfolio for vafidemstat during this quarter. The European Patent Office (EPO) recently granted Oryzon’s European patent EP3661510B1, titled “Methods of treating behavior alterations”; the granted claims cover the use of vafidemstat for the treatment of aggression and social withdrawal. A corresponding patent has also been granted in South Korea and we have received “intention to grant” communications in Australia and Malaysia. These patents will not expire until at least 2038, excluding any potential patent term extension that may provide additional years of protection. In addition, Oryzon has received “intention to grant” communications in Europe and Mexico for another key patent family related to vafidemstat titled “Methods of treating borderline personality disorder”, and a corresponding patent has been granted in Japan. These patents will not expire until at least 2040, excluding potential patent term extensions that may provide additional protection. Another patent, covering the use of vafidemstat to treat ADHD, has also been granted in Japan during this period. The EVOLUTION Phase IIb clinical trial evaluating vafidemstat in patients with schizophrenia continues to enroll participants. This study aims to assess the efficacy of vafidemstat, with a primary focus on improving negative symptoms. Following a careful analysis of effect sizes observed in BPD, we have reevaluated and increased the recruitment target for the trial. In addition to negative symptoms, the trial is also exploring as secondary endpoints vafidemstat’s efficacy in improving cognitive impairment and positive symptoms in schizophrenia. The project is partially funded by the Spanish Ministry of Science and Innovation and is being conducted at multiple hospitals across Spain. Vafidemstat in monogenic CNS indications: We continue to evaluate the feasibility of a new precision medicine trial in Kabuki Syndrome. The company will decide on a possible submission of an IND for HOPE to the FDA in 2025. Iadademstat in oncology: FRIDA, an open-label, multicenter Phase Ib clinical trial of iadademstat in combination with gilteritinib in patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) harboring a FMS-like tyrosine kinase mutation (FLT3mut+), continues to enroll patients. Following the FDA’s new OPTIMUS doctrine, the company continues to explore the minimal dose with clinical activity. The primary objectives of the trial are to evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3mut+ R/R AML and to establish the Recommended Phase 2 Dose (RP2D) for this combination. Secondary objectives include the evaluation of the treatment efficacy, measured as the rate of complete remission and complete remission with partial hematological recovery (CR/CRh), the Duration of Responses (DoR), and the assessment of Measurable Residual Disease (MRD). The study is being conducted in the U.S. and will accrue up to approximately 45 patients. If successful, Oryzon and the FDA have agreed to hold a meeting to discuss the best plan to further develop this combination in this much-in-need AML population. The first patients have been dosed in the Investigator-initiated study (IIS) sponsored by the Oregon Health & Science University (OHSU) Knight Cancer Institute evaluating the combination of iadademstat with venetoclax and azacitidine in first line AML. Dr. Curtis Lachowiez is the Principal Investigator (PI) of the trial. This Phase Ib dose-finding study is now actively enrolling patients. Iadademstat will also be evaluated in combination with venetoclax and azacitidine in first-line AML patients in a trial under the Cooperative Research and Development Agreement (CRADA) signed with the National Cancer Institute (NCI) in the United States. The trial will be conducted and sponsored by the NCI, with Dr. Natalie Galanina from the University of Pittsburgh Cancer Institute as the main PI for the trial. The trial plans to enroll 45 patients and, according to NCI, is expected to start enrolling patients in 4Q2024. The Company is further expanding the clinical development of iadademstat in hemato-oncology through a new IIS led by the Medical College of Wisconsin, which will evaluate iadademstat in combination with azacitidine in adult subjects with myelodysplastic syndrome. The collaborative Phase II basket trial of iadademstat in combination with paclitaxel in platinum R/R small cell lung cancer (SCLC) and extrapulmonary high-grade neuroendocrine tumors (NET trial) continues to enroll patients. This trial is being conducted in the U.S. under a collaborative clinical research agreement with the Fox Chase Cancer Center. The Phase I/II trial with iadademstat plus immune checkpoint inhibitors in first line SCLC patients with extensive disease under the CRADA agreement with the NCI, already approved by the FDA, is now ready to start enrolling patients. The trial is titled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer” and will be conducted and sponsored by the NCI, with Dr. Charles Rudin from the Memorial Sloan Kettering Cancer Center (MSKCC) as the main PI for the trial, and Dr. Noura Choudhury from University of Chicago as co-PI A number of prestigious cancer centers in the US, including the MSKCC, the JHU Sidney Kimmel Comprehensive Cancer Center and many others will participate. The trial plans to enroll 45-50 patients and is expected to start enrolling patients in 4Q2024. The STELLAR trial, a randomized, multicenter Phase II study of iadademstat plus a checkpoint inhibitor in first-line extensive-stage SCLC, will be informed and refined from the findings of the CRADA-MSKCC trial. The company believes that STELLAR could potentially support an application for accelerated approval. Earlier stage programs: ORY-4001, Oryzon’s highly selective histone deacetylase 6 (HDAC6) inhibitor nominated as a clinical candidate for the treatment of certain neurological diseases such as Charcot-Marie-Tooth disease (CMT), Amyotrophic Lateral Sclerosis (ALS) and others, continues to progress through IND enabling studies to prepare it for clinical studies. Financial Update: Third quarter 2024 Financial Results Research and development (R&D) expenses were $1.9 million and $7.1 million for the quarter and nine months ended September 30, 2024, compared to $3.8 and $12.2 million for the quarter and nine months ended September 30, 2023. As a result of the completion of the PORTICO clinical trial, the company saves $5.1M with respect to the third quarter of 2023. General and administrative expenses were $0.9 and $3.1 million for the quarter and nine months ended September 30, 2024, compared to $0.7 and $2.9 million for the quarter and nine months ended September 30, 2023. Net losses were $1.1 and $3.8 million for the quarter and nine months ended September 30, 2024, compared to $0.8 and 3.4 million for the quarter and nine months ended September 30, 2023. The result is as expected, given the biotechnology business model where companies in the development phase typically have a long-term maturation period for products and do not have recurrent income. Negative net result was $2.5 million (–$0.04 per share) for the nine months ended September30, 2024, compared to a negative net result of $1.7 million (–$0.03 per share) for the nine months ended September 30, 2023. Cash, cash equivalents, and marketable securities totaled $8.4 million as of September 30, 2024. ORYZON GENOMICS, S.A. BALANCE SHEET DATA (UNAUDITED) 1 (Amounts in thousands US $) September 30th, 2024 September 30th, 2023 Cash and cash equivalents 8,442 8,818 Marketable securities 0 0 Total Assets 122,661 108,303 Deferred revenue 0 0 Total Stockholders’ equity 96,854 83,920 ORYZON GENOMICS, S.A. STATEMENTS OF OPERATIONS (UNAUDITED) 1 (US $, amounts in thousands except per share data) Three Months Ended September 30th Nine Months Ended September 30th 2024 2023 2024 2023 Collaboration Revenue 0 0 0 0 Operating expenses: Research and Development 1,915 3,821 7,076 12,237 General and administrative 879 674 3,051 2,934 Total operating expenses 2,794 4,495 10,127 15,171 Loss from Operations -2,794 -4,495 -10,127 -15,171 Other income, net 1,671 3,669 6,312 11,728 Net Loss -1,123 -826 -3,815 -3,443 Net Financial & Tax -256 -300 1,272 1,716 Net Result -1,379 -1,126 -2,543 -1,727 Loss per share allocable to common stockholders: Basic -0.02 -0.02 -0.04 -0.03 Weighted average Shares outstanding Basic 63,383,939 58,154,298 62,336,626 57,234,937 1 Spanish GAAP About Oryzon Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate ORY-4001, has been nominated for its possible development in CMT and ALS. 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 . 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 efficacy data 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 gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations, and in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study led by OHSU. 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 being evaluated in a collaborative Phase II basket study with the Fox Chase Cancer Center (FCCC) in combination with paclitaxel in R/R neuroendocrine carcinomas, and the company is preparing a new trial in combination with immune checkpoint inhibitors (ICI) in SCLC. Oryzon has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to collaborate on potential further clinical development of iadademstat in different types of solid and hematological cancers; the first two trials will evaluate iadademstat in combination with ICI in SCLC and in combination with azacitidine and venetoclax in 1L AML. Oryzon is further expanding the clinical development of iadademstat through additional investigator-initiated studies. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. 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 anti-inflammatory 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. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in negative symptoms of schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, completed and with published final data. Following receipt of the minutes from the End-of-Phase II meeting with the FDA to discuss PORTICO’s results, the company recently announced plans to move forward with a Phase III PORTICO-2 trial in BPD. The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is evaluating a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes. 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 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. Spain Oryzon IR, US IR & Media, Europe Patricia Cobo/Mario Cordera Emili Torrell Ashley R. Robinson Sandya von der Weid Atrevia Chief Business Officer LifeSci Advisors, LLC LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +1 617 430 7577 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com arr@lifesciadvisors.com svonderweid@lifesciadvisors.com

Phase 2Clinical ResultPhase 1Phase 3Financial Statement

07 Oct 2024

·www.globenewswire.com

Galecto Completes Strategic Review to Focus on Oncology and Liver Disease and Acquires Acute Myeloid Leukemia Preclinical Asset from Bridge Medicines

Galecto will focus on cancer and liver disease, leveraging existing clinical stage asset GB1211Bolsters pipeline by obtaining global rights to BRM-1420, a novel dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML)BRM-1420 has the potential for enhanced clinical effectiveness compared to FLT3 inhibitors alone and has shown synergistic effects with SOC in preclinical models BOSTON, Oct. 07, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that, following an intensive strategic review process, Galecto has determined to focus on cancer and liver disease, leveraging its existing clinical stage asset GB1211, which has shown positive results in non-small cell lung cancer (NSCLC) and decompensated cirrhosis clinical studies. Galecto further announced that it has bolstered its pipeline with the acquisition of the global rights to BRM-1420, a novel, first-in-class asset developed by Bridge Medicines, a company co-founded by Takeda. “Our strategic review process concluded that our best opportunity for building value and changing the lives for patients with severe diseases was to focus on our existing clinical stage compound GB1211 and increase our chance for success by acquiring complementary assets. The addition of BRM-1420 represents a significant advancement in our mission to develop and deliver breakthrough treatments for oncology and liver conditions,” said Dr. Hans Schambye, CEO of Galecto. “We are particularly optimistic about BRM-1420's potential to address challenging genetic subsets of AML and its observed synergistic effects with standard-of-care therapies and menin inhibitors.” “AML is the most common acute leukemia in adults, yet despite available treatments, patient prognosis remains poor with significant unmet needs,” said Miles Gerson, Head of Takeda Ventures and Takeda’s Representative to Bridge Medicines. “Bridge Medicines has made considerable progress in recent years developing this new class of drugs and Galecto’s team is well positioned to continue advancing BRM-1420.” As consideration for the acquisition of the global rights of BRM-1420, Galecto issued 62,594 shares of common stock to Bridge Medicines, representing 4.99% of the outstanding shares of Galecto’s common stock as of the date of the asset purchase, and 160.562 shares of a newly-issued Series A preferred stock convertible into 160,562 shares of common stock, or approximately 12.8% of Galecto’s common stock, upon receipt of stockholder approval. Matthew Kronmiller, Bridge Medicine’s Chief Executive Officer, will be joining Galecto’s management team as the Executive Vice President of Strategy and Chief Business Officer. The transaction was approved by the Boards of Directors of both companies. Leerink Partners served as the exclusive financial advisor to Galecto and Lazard served as exclusive financial advisor to Bridge Medicines. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Galecto. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as legal counsel to Bridge Medicines. About BRM-1420BRM-1420 is a potent and selective ENL-YEATS and FLT3 inhibitor of multiple genetic subsets of AML. It disrupts key oncogenic pathways by inhibiting these domains, showing potent activity in MLLr and NPM1c cell lines. Promising preclinical and in vivo results highlight its efficacy in inhibiting leukemia cell growth and extending survival in AML models. In animal models, BRM-1420 exhibited superior efficacy to both FLT3 and menin inhibitors and was shown to inhibit cell proliferation in primary AML patient samples across multiple genotypes, including MLL-r, NPM1m, cKIT+, FLT3+, TET2+, and TP53+. These mutations are often seen in AML and, in total, could account for greater than 30% of the AML patient population. Many of these mutations have proven difficult to treat with currently available regimens and therefore represent a significant unmet medical need. The Company believes, based on preclinical data, that BRM-1420 could be additive or synergistic when used in combination with the current standard of care (azacitidine, venetoclax, cytarabine, gilteritinib), as well as current therapies under development, such as menin inhibitors. Galecto plans to file an IND for BRM-1420 in the US in late 2025 or early 2026 and initiate clinical studies in patients with AML thereafter. Exclusive global rights to the program were assigned by Bridge Medicines to Galecto through a license with The Rockefeller University. The pioneering discoveries were a result of collaboration between the Rockefeller University and the Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI), followed by licensing by Bridge Medicines. About Galecto’s PipelineGalecto continues to develop GB1211, its first-in-class, oral small molecule, galectin-3 inhibitor for the treatment of oncology and severe liver cirrhosis. GB1211 is currently being studied in an investigator-initiated Phase 2 trial at Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). GB1211 is being administered in combination with the standard therapeutic dose of pembrolizumab (Keytruda®) in patients with unresectable or metastatic melanoma or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. This trial is designed to evaluate the safety and efficacy of GB1211 in combination with pembrolizumab and determine whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. This trial was initiated and enrolled its first patient in the second quarter of 2024. In addition, during the second half of 2023, Galecto concluded its Phase 1b/2a trial examining GB1211 in combination with atezolizumab, a PD-L1 checkpoint inhibitor, for the treatment of first-line non-small cell lung cancer (NSCLC). Four patients in this trial showed a partial response according to RECIST criteria (version 1.1), and two of these four patients continue to receive treatment in the extension phase of the trial. As part of the strategic alternative review process, Galecto has determined not to further advance GB2064, its LOXL-2 inhibitor candidate, at this time. About GalectoGalecto is a clinical-stage biopharmaceutical company committed to realizing the promise of novel treatments for cancer and liver diseases. The Company’s pipeline consists of first-in-class small molecule drug candidates that target cancer and fibrosis signaling pathways, including (i) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis; (ii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications; and (iii) a preclinical dual inhibitor of ENL-YEATS and FLT3 (BRM-1420) for multiple genetic subsets of AML. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking StatementsCertain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s preclinical and clinical development plans for BRM-1420; BRM-1420's potential to address challenging genetic subsets of AML and its observed synergistic effects with standard-of-care therapies and menin inhibitors; that BRM-1420 has the potential to transform the treatment of AML; that the MLL-r, NPM1m, cKIT+, FLT3+, TET2+, and TP53+ mutations could account for greater than 30% of the AML patient population; and that BRM-1420 could be additive or synergistic when used in combination with current standard of care as well as current therapies under development. Such forward-looking statements include statements about Galecto’s focus and plans for preclinical and clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 8, 2024. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. For more information, contact: Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comSandya von der Weidsvonderweid@lifesciadvisors.com+1 617 430 7577+41 78 680 0538

Phase 2License out/in

09 Sep 2024

·www.globenewswire.com

ORYZON Announces First Patient Dosed in an Investigator-Initiated Phase Ib Study of Iadademstat in First-Line Acute Myeloid Leukemia

Exploring the triple combination with venetoclax and azacitidineStudy sponsored by Oregon Health & Science University (OHSU) MADRID and CAMBRIDGE, Mass., Sept. 09, 2024 (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 that the first patient has been dosed in an investigator-initiated Phase Ib dose-finding trial of iadademstat, Oryzon’s potent and selective LSD1 inhibitor, in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML), sponsored by the Oregon Health & Science University (OHSU) Knight Cancer Institute. Under the direction of Dr. Curtis Lachowiez at OHSU Knight Cancer Institute, the study (NCT06357182) aims to test the safety, tolerability, and best dose of iadademstat when administered together with the standard-of-care venetoclax and azacitidine in treating patients with newly diagnosed AML. The trial also aims to assess the preliminary efficacy of the triple combination. Dr. Curtis Lachowiez, Principal Investigator of the study, stated: “Given the activity observed with LSD1 inhibition in combination with azacitidine in AML, testing a triplet combination including iadademstat with the highly active backbone of azacitidine+venetoclax is the logical next step to hopefully improve outcomes of patients living with AML if proven to be safe and active”. Dr. Carlos Buesa, Oryzon’s CEO, added: “This trial builds on the positive results obtained in our ALICE trial in first-line AML, where the combination of iadademstat with azacitidine showed strong antileukemic activity with deep and durable responses and a manageable safety profile, including in patients with high-risk prognostic factors that respond poorly to venetoclax+azaciditine.” In AML, iadademstat is also being evaluated in a company-sponsored Phase Ib trial in combination with gilteritinib in patients with relapsed/refractory AML harboring a FMS-like tyrosine kinase mutation (FLT3mut+). This FRIDA trial is being conducted in the U.S. Preliminary results from FRIDA, corresponding to the first two cohorts, were recently presented at the European Hematology Association (EHA) 2024 congress in June. Our results demonstrated that combination of iadademstat plus gilteritinib was safe and well tolerated, and showed encouraging antileukemic activity. About Oryzon Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate ORY-4001, has been nominated for its possible development in CMT and ALS. 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 IadademstatIadademstat (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 efficacy data 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 gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations. 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 being evaluated in a collaborative Phase II basket study with the Fox Chase Cancer Center (FCCC) in combination with paclitaxel in R/R neuroendocrine carcinomas, and the company is preparing a new trial in combination with immune checkpoint inhibitors (ICI) in SCLC. Oryzon has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to collaborate on potential further clinical development of iadademstat in different types of solid and hematological cancers; a first trial in combination with ICI in SCLC has recently received FDA IND approval. Oryzon is further expanding the clinical development of iadademstat through investigator-initiated studies. 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 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. Spain Oryzon IR, US IR & Media, Europe Patricia Cobo/Mario Cordera Emili Torrell Ashley R. Robinson Sandya von der Weid Atrevia Chief Business Officer LifeSci Advisors, LLC LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +1 617 430 7577 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com arr@lifesciadvisors.com svonderweid@lifesciadvisors.com

Phase 1Phase 2Clinical ResultOrphan DrugImmunotherapy

100 Deals associated with Gilteritinib Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE54	DB12141

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	CA	Astellas Pharma Canada, Inc.	23 Dec 2019
FLT3 positive Acute Myeloid Leukemia	JP	Astellas Pharma, Inc.	21 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 3	BE	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	IL	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	GB	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	DE	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	KR	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	ES	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	TW	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	IT	Astellas Pharma Global Development, Inc.	20 Oct 2015
Refractory acute myeloid leukemia	Phase 3	JP	Astellas Pharma Global Development, Inc.	20 Oct 2015
Acute Myeloid Leukemia	Preclinical	CN	Astellas Pharma China, Inc.	11 Apr 2020

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05010772 (4277, ASH2024)	Phase 1	Acute Myeloid Leukemia complex cytogenetics \| antecedent MDS/MPN \| therapy-related AML ... View more	31	ASTX727 alone	(jdewkwldeb) = tdmsvbkjer yzxypgkgcm (mfqbphucbm ) View more	Positive	09 Dec 2024
				ASTX727 plus venetoclax	(jdewkwldeb) = avgugwhajb yzxypgkgcm (mfqbphucbm ) View more
ASH2024	Not Applicable	-	-	Cladribine, Idarubicin, and Cytarabine (CLIA) + Gilteritinib	slnfjyqdnp(oauzyptbiy) = n = 5 qjnmcvckof (byuiezemoh ) View more	-	08 Dec 2024
ASH2024	Not Applicable	-	-	Gilteritinib	ssvnvpqend(juagaiqsqi) = grade >=3 TRAE was reported in 73%G vs 70% M during induction and 79%G vs 73%M pts during consolidation croahljydo (vvqjqgangu )	-	07 Dec 2024
				Midostaurin
ASH2024	Not Applicable	-	-	CPX-351 + Gilteritinib 120mg	cxvtsqerxv(aitrxyjxyi) = febrile neutropenia (33.3%), GI related (53.3%), fatigue/weakness (33.3%), and elevated LFTs (13.3%) dogvlwkugk (zodcfpykxx )	-	07 Dec 2024
NCT02310321 (CTgov)	Phase 1/2	Acute Myeloid Leukemia with FLT3/ITD Mutation	97	Cytarabine+Idarubicin+Gilteritinib (Phase 1: Dose Evaluation (DEv))	pwdbleteaz(tzkpzlwjhe) = hzgxkcqoxm qqvbvempgn (ardsodrgov, pfbcuvvmch - wbvozmskns) View more	-	16 Oct 2024
				Cytarabine+Idarubicin+Gilteritinib (Phase 1: Dose Expansion (DEx))	vmksjbqvbf(inddxhtvnz) = xzhvyfguup qopwxdpzyd (gktteerewc, kfcfqsjnme - pmrhokeqxp) View more
NCT02997202 (ADMIRAL, CTgov)	Phase 3	Acute Myeloid Leukemia with FLT3/ITD Mutation	356	gilteritinib (Gilteritinib)	zetqcxfnto(sapmvvrrhp) = bnyswlykur lxdbctjosv (whnnchjbac, eskkpdkzsv - exmhsfvgxi) View more	-	19 Sep 2024
				Placebo (Placebo)	zetqcxfnto(sapmvvrrhp) = iakonplgwd lxdbctjosv (whnnchjbac, hlrgrzqfyx - orufxdhbuo) View more
SOHO2024	Not Applicable	Acute Myeloid Leukemia	-	Gilteritinib monotherapy	(rjlegduupe) = jjvcjlptxo lifvcjvddd (ebeogkvkdf ) View more	-	04 Sep 2024
				Gilteritinib + Venetoclax	(rjlegduupe) = sepwxjczjt lifvcjvddd (ebeogkvkdf ) View more
NCT05010122 (EHA2024) Manual	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes First line	26	ASTX727 withVENand GILT (newly diagnosed)	(dyxoisiiiz) = nvfqhfvaog vpmcsbupos (nbpzelxkzv ) View more	Positive	14 May 2024
				ASTX727 with VEN and GILT (relapsed/refractory)	(dyxoisiiiz) = avnjwfcafj vpmcsbupos (nbpzelxkzv ) View more
NCT03182244 (COMMODORE, EHA2024) Manual	Phase 3	Acute Myeloid Leukemia with FLT3/ITD Mutation Second line	234	Gilteritinib 120 mg/day (China)	(iayuhnrbms) = tnwbmiyokr dzkyvwibkh (ujzjbuhnij ) View more	Positive	14 May 2024
				Salvage Chemotherapy (China)	(iayuhnrbms) = uirfnormkn dzkyvwibkh (ujzjbuhnij ) View more
EHA2024	Not Applicable	Relapsing acute myeloid leukemia FLT3-mutated	29	Gilteritinib+Venetoclax+Azacitidine	fwkivuvjur(qfvdwckneg) = ydutrrigai fouasemeii (ldpxdnkylq ) View more	Positive	14 May 2024

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