- |||||||||| metformin / Generic mfg., ME-344 / MEI
Biomarker, Journal: Identification of NDUFV2, NDUFS7, OPA1, and NDUFA1 as biomarkers for Alzheimer's disease: Insights from oxidative stress and mitochondrial dysfunction in the hippocampus. (Pubmed Central) - Jul 1, 2025
These genes showed good diagnostic performance. Potential drugs, like ME-344 and metformin hydrochloride, may be useful in AD treatment.ConclusionsNDUFV2, NDUFS7, OPA1, and NDUFA1 can serve as biomarkers for AD diagnosis.
- |||||||||| pracinostat (SB939) / Helsinn, MEI, Menarini
Journal, Metabolomic study: Genomic and metabolomic insights into the antimicrobial compounds and plant growth-promoting potential of Bacillus velezensis B115. (Pubmed Central) - Mar 28, 2025
Utilizing LC-MS/MS technologies, 2318 metabolites were detected in the fermentation broth of B. velezensis B115, encompassing compounds such as Corynebactin, Gamabufotalin, Pracinostat, Indoleacetic acid, (8)-Gingerol, Luteolin, Liquiritigenin, and other metabolites with antimicrobial, growth-promoting, antioxidant, and antitumor properties. By exploring secondary metabolite-related genes and predicting potential secondary metabolites from the B115 genome based on the whole-genome sequence results, we further elucidate the genomic basis for its ability to promote plant growth and inhibit pathogen activity.
- |||||||||| mocetinostat (MGCD0103) / Otsuka, BMS, pracinostat (SB939) / Helsinn, MEI, Menarini, tanespimycin (BMS-722782) / BMS
High throughput drug screening on head and neck cancer organoids reveals novel therapeutic strategies (Elite Exhibit Hall (Main Tower, 1st Floor)) - Mar 26, 2025 - Abstract #COSM2025COSM_1150;
Specifically, HSP90 and HDAC inhibitors were most effective within their drug class. Pending dose response experiments and validation across a larger cohort, these results provide potential novel protein and epigenetic targeting strategies as promising approaches in HNSCC.
- |||||||||| Beleodaq (belinostat) / Aurobindo, Assertio, pracinostat (SB939) / Helsinn, MEI, Menarini
Overcoming resistance in mCRPC: drug discovery using PDX models and high-throughput drug screening (Section 22; Poster Board No: 3) - Mar 25, 2025 - Abstract #AACR2025AACR_7934;
In summary, we leveraged RNAseq data from mCRPC patients and PDX models and performed a high-throughput drug screen in PDX-derived organoid models to identify potential drugs that could overcome abiraterone-resistance in lethal advanced prostate cancer. These data highlight potential drug combinations or subsequent therapeutic strategies for these patients.Summary of drug screening in PDX-derived organoidsAbiraterone SensitiveAbiraterone Resistant-1Abiraterone Resistant-2Active (IC5025
- |||||||||| NV-128 / MEI
ME128 - How to apply organoid models to study infectious disease (Hall 14) - Feb 1, 2025 - Abstract #ESCMIDGlobal2025ESCMID_Global_790;
These tools offer exciting insights into host-pathogen interactions and therapeutic applications at a molecular level. In this MTE, both the application of organoid models in molecular biology and their clinical use to study and combat infectious diseases, including their potential to advance personalised medicine, will be presented.
- |||||||||| mocetinostat (MGCD0103) / Otsuka, BMS, CUDC-101 / Curis, pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: HDAC Inhibitors Can Enhance Radiosensitivity of Head and Neck Cancer Cells Through Suppressing DNA Repair. (Pubmed Central) - Dec 17, 2024
We also demonstrated that this combinatorial strategy leads to inhibition of the repair of DNA double-strand breaks through the neutral comet assay and ?H2AX foci analysis using immunofluorescence microscopy, providing a mechanism of action through which HDAC inhibition functions in HNSCC radiosensitisation. We believe that this approach should be further investigated in preclinical models, in order to realise the full therapeutic potential of HDAC inhibition for the radiosensitisation of HNSCC, eventually leading to improved patient treatment efficacy and outcomes.
- |||||||||| zandelisib (ME-401) / MEI
PI3 Kinase Pathway Regulates CAR T Cell Trogocytosis (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3688;
We have shown that PI3K p110? pathway is an important regulator of CAR mediated trogocytosis and targeting this pathway could be of potential clinical benefit.
- |||||||||| abexinostat (CG-781) / Xynomic, pracinostat (SB939) / Helsinn, MEI, Menarini, EPZ015666 / GSK, Ipsen
Three novel epigenetic-modifying compounds identified as HIV latency-reversing agents in Ghana (Convention Center - Hall I-1 (1st Floor); In-Person-Only) - Oct 11, 2024 - Abstract #ASTMH2024ASTMH_1607;
These compounds effectively reactivated latent HIV-1 in vitro and induced HIV expression ex vivo. Our findings suggest that these LRAs hold promise for reactivating latent HIV in individuals living with the virus.
- |||||||||| riluzole / Generic mfg., NV-128 / MEI, ME-344 / MEI
Journal: Correlation of disulfidptosis and periodontitis: New insights and clinical significance. (Pubmed Central) - Jul 28, 2024
The intermittent dosing resulted in a relatively low incidence of severe class-related toxicities, which supports the evaluation of zandelisib as a single agent and in combination with indolent B-cell malignancies. SLC7A11, SLC3A2, RPN1, NCKAP1, LRPPRC, and NDUFS1 are targets associated with disulfidptosis in periodontitis, and ME-344, NV-128, and RILUZOLE are promising agents for the treatment of periodontitis.
- |||||||||| zandelisib (ME-401) / MEI
Trial completion date, Trial primary completion date: Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - Jul 17, 2024
P2, N=61, Active, not recruiting,
SLC7A11, SLC3A2, RPN1, NCKAP1, LRPPRC, and NDUFS1 are targets associated with disulfidptosis in periodontitis, and ME-344, NV-128, and RILUZOLE are promising agents for the treatment of periodontitis. Trial completion date: Sep 2024 --> May 2028 | Trial primary completion date: Sep 2024 --> May 2028
- |||||||||| LOW DOSE DOUBLE EPIGENETIC THERAPY IMPROVES IMMUNOTHERAPY RESPONSE AND PROLONGS SURVIVAL IN PANCREATIC CANCER. (103AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_2386;
We previously showed, using the KPC (Kras LSL G12D/+; p53 r172H/+; Pdx1-Cre) mouse model of pancreatic cancer (PDAC), that sequential treatment with the DNA hypomethylating agent (HMA) decitabine (DAC) followed by aPD-1 initially enhanced anti-tumor effects, yet tumors developed resistance linked to a unique M2-polarized Chil3+ myeloid subtype...We then evaluated four different HDAC inhibitors with reported immunomodulatory effects and non-overlapping HDAC isoform specificities: Romidepsin (RM), Domatinostat (DM), Pracinostat (PR) and Entinostat (EN)...Our findings identify a functionally immune suppressive HMA specific myeloid effect. The addition of a second epigenetic agent enhances the therapeutic efficacy resulting in prolonged survival and reverses the suppressive myeloid cell related effects of DAC + aPD1.
- |||||||||| Increasing the therapeutic vulnerability of heterogenous cell phenotypes within prostate cancer (Section 13) - Mar 5, 2024 - Abstract #AACR2024AACR_7394;
Funding was provided by the University of Arizona Cancer Center (NCI-P30 CA23074 and NCI-R01 CA159406) and by the Partnership in Native American Cancer Prevention at the University of Arizona (U54CA143924) and Northern Arizona University (U54CA143925). Collaborators at NCATS were supported by the intramural research program.
- |||||||||| pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: ALDH1A3 contributes to tumorigenesis in high-grade serous ovarian cancer by epigenetic modification. (Pubmed Central) - Mar 4, 2024
CHIP assay demonstrated a significant enrichment of H3K27ac at the PITX1 promoter, and ALDH1A3 knockdown reduced the binding between H3K27ac and PITX1. Taken together, our data suggest that ALDH1A3, transcriptional activated by HIF-1?, promotes tumorigenesis and decreases chemosensitivity by increasing H3K27ac of PITX1 promoter in HGSOC.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, ME-344 / MEI
Preclinical, Journal: Enhancing anti-AML activity of venetoclax by isoflavone ME-344 through suppression of OXPHOS and/or purine biosynthesis in vitro. (Pubmed Central) - Jan 29, 2024
Venetoclax (VEN), in combination with low dose cytarabine (AraC) or a hypomethylating agent, is FDA approved to treat acute myeloid leukemia (AML) in patients who are over the age of 75 or cannot tolerate standard chemotherapy...Further, lometrexol, a purine biosynthesis inhibitor, synergistically enhanced VEN-induced apoptosis in AML cell lines...In vivo studies revealed significantly prolonged survival upon combination therapy of ME-344 and VEN in NSGS mice bearing parental or AraC-resistant MV4-11 leukemia compared to the vehicle control. This study demonstrates that ME-344 enhances VEN antileukemic activity against preclinical models of AML by suppressing OXPHOS and/or purine biosynthesis.
- |||||||||| zandelisib (ME-401) / MEI
Enrollment closed, Enrollment change: ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Dec 20, 2023
P1/2, N=13, Active, not recruiting,
This study demonstrates that ME-344 enhances VEN antileukemic activity against preclinical models of AML by suppressing OXPHOS and/or purine biosynthesis. Recruiting --> Active, not recruiting | N=54 --> 13
- |||||||||| Avastin (bevacizumab) / Roche, ME-344 / MEI
A phase 1b study of the OxPhos inhibitor ME-344 in combination with bevacizumab in refractory metastatic colorectal cancer. (Level 1, West Hall; Poster Bd # N10) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_635;
P1/2
This is an open-label phase 1b study in patients ?18 years old with metastatic colorectal cancer after failure of standard therapies, including fluoropyrimidine-, irinotecan-, and oxaliplatin-based regimens, anti-EGFR if RAS wild-type, PD/L-1-blocking antibody if MSI-H/dMMR, and BRAF-targeted therapy if BRAF V600E mutated...The study is actively enrolling, funded by MEI Pharma, and registered under NCT02100007. Clinical trial information: NCT02100007.
- |||||||||| AT9283 / Otsuka, Xospata (gilteritinib) / Astellas, pracinostat (SB939) / Helsinn, MEI, Menarini
Journal, BRCA Biomarker: The Comprehensive Analysis of m6A-Associated Anoikis Genes in Low-Grade Gliomas. (Pubmed Central) - Sep 28, 2023
Four risk model genes (mRNAs), 12 miRNAs, and 21 lncRNAs formed an mRNA-miRNA-lncRNA network, containing HOXA10-hsa-miR-129-5p-LINC00689 and KIF18A-hsa-miR-221-3p-DANCR. Through bioinformatics, we constructed a prognostic model of m6A-associated anoikis genes in LGG, providing new ideas for research related to the prognosis and treatment of LGG.
- |||||||||| pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: HDAC inhibitor SB939 potentiates TRAIL-induced apoptosis in colorectal cancer cells. (Pubmed Central) - Aug 16, 2023
The ability of SB939 to sensitize HT-29 cells suggests that SB939 can induce essential changes in cell signaling pathways. Thus, the pan-HDAC inhibitor SB939 sensitizes TRAIL-induced apoptosis via up-regulation of DR5, and SB939-TRAIL combined treatment may target the MAPK pathways and serve as an effective therapeutic strategy against CRC.
- |||||||||| ME-344 / MEI
Trial initiation date, Metastases: ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 14, 2023
P1b, N=40, Recruiting,
Thus, the pan-HDAC inhibitor SB939 sensitizes TRAIL-induced apoptosis via up-regulation of DR5, and SB939-TRAIL combined treatment may target the MAPK pathways and serve as an effective therapeutic strategy against CRC. Initiation date: May 2023 --> Aug 2023
- |||||||||| zandelisib (ME-401) / MEI, Tazverik (tazemetostat) / Eisai, Ipsen
Enrollment change, Trial withdrawal: Zandelisib + Tazemetostat in R/R Follicular Lymphoma (clinicaltrials.gov) - Jul 7, 2023
P1/2, N=0, Withdrawn,
Initiation date: May 2023 --> Aug 2023 N=34 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| zandelisib (ME-401) / MEI
Trial completion date, Trial termination, Trial primary completion date: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) (clinicaltrials.gov) - May 9, 2023
P2, N=169, Terminated,
Marginal zone, Indolent non-Hodgkin's lymphoma, Follicular lymphoma, PI3K Trial completion date: Apr 2025 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2023; discontinuation of zandelisib program
- |||||||||| zandelisib (ME-401) / MEI
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (clinicaltrials.gov) - May 9, 2023
P3, N=82, Terminated,
Trial completion date: Apr 2025 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2023; discontinuation of zandelisib program N=534 --> 82 | Trial completion date: Sep 2031 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Mar 2023; Discontinuation of zandelisib program
- |||||||||| zandelisib (ME-401) / MEI
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Monotherapy: ME-401-002: A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma (clinicaltrials.gov) - May 9, 2023
P1, N=97, Terminated,
N=534 --> 82 | Trial completion date: Sep 2031 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Mar 2023; Discontinuation of zandelisib program N=177 --> 97 | Trial completion date: Dec 2023 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2023 --> Mar 2023; discontinuation of zandelisib program
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