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  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, NTX-301 / PinotBio, Aston Sci.
    Exploring new approaches to widening of the therapeutic index of ADCs with dual-payload design and combination with a novel HMA (Section 16; Poster Board No: 19) -  Mar 25, 2025 - Abstract #AACR2025AACR_9072;    
    Recent approvals of ADCs such as trastuzumab deruxtecan, sacituzumab govitecan have significantly improved patient treatment options, underscoring the clinical potential of this therapeutic class...One promising approach involves the combination of the ADC with NTX-301, a novel 4?-thio-modified analog of decitabine (DAC)...In this study, we present novel strategies to enhance the therapeutic index of ADCs through a dual-payload design and combination with NTX-301. These results highlight the potential of both approaches for further development in cancer treatment.
  • ||||||||||  AST-302 / Aston Sci., EpiThany
    Trial completion date, Trial primary completion date:  MCC-19117: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (clinicaltrials.gov) -  Feb 6, 2025   
    P2,  N=119, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Apr 2025 Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2025
  • ||||||||||  AST-302 / Aston Sci., EpiThany
    Trial completion date, Trial primary completion date:  MCC-19117: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (clinicaltrials.gov) -  Dec 13, 2024   
    P2,  N=119, Active, not recruiting, 
    Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2025 Trial completion date: Dec 2026 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Mar 2026
  • ||||||||||  EP-202 / EpiThany, Aston Sci.
    Pharmacological and Pharmacokinetic Evaluation of AST-202, CD25-Targeted Aptamer Conjugated with Anti-Mitotic MMAE Warhead for the Treatment of Hematological Malignancies () -  Dec 7, 2024 - Abstract #ASH2024ASH_7922;    
    This improvement of stability was found to translate to improved PK profile relative to AST-202(1), resulting in the dramatic increase of AUC and half-life as well as the decreased CL.Cytotoxicity evaluation against a panel of human lymphoma and leukemia cell lines with different CD25-expression level revealed the correlation of the expression level of the target and CD25-negative Daudi and H929 cells (derived from B-cell lymphoma and multiple myeloma, respectively) were not affected in the range of treatment up to 1uM.Comparative in vivo study with subcutaneous xenografts of AST-202 and single MMAE-conjugated aptamer demonstrated CD25-specific tumor targeting and the superior anti-tumor efficacy of AST202 relative to ApDC with a single payload. The following study with a disseminated tumor model showed dramatic extensions of survival in all treatment groups compared with vehicle and non-binding ApDC controls and survival difference between AST-202(1) and AST-202(3) was not observed at the tested dose range.Consequently, based on the improved in vitro stability, PK profile, and efficacy, AST-202(3) which is a novel micellar aptamer-drug conjugate could be a potential candidate for further preclinical development as a therapeutic candidate against hematological malignancies.
  • ||||||||||  AST-302 / Aston Sci., EpiThany
    Trial completion, Enrollment change:  WOKVAC: Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (clinicaltrials.gov) -  Sep 19, 2024   
    P1,  N=32, Completed, 
    The following study with a disseminated tumor model showed dramatic extensions of survival in all treatment groups compared with vehicle and non-binding ApDC controls and survival difference between AST-202(1) and AST-202(3) was not observed at the tested dose range.Consequently, based on the improved in vitro stability, PK profile, and efficacy, AST-202(3) which is a novel micellar aptamer-drug conjugate could be a potential candidate for further preclinical development as a therapeutic candidate against hematological malignancies. Active, not recruiting --> Completed | N=24 --> 32
  • ||||||||||  AST-301 / University of Washington, Aston Sci., EpiThany
    Trial primary completion date:  Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov) -  Jul 9, 2024   
    P2,  N=24, Recruiting, 
    There is no visible evidence of biliary ductal dilatation in either view. Trial primary completion date: Oct 2023 --> Oct 2025
  • ||||||||||  AST-301 / University of Washington, Aston Sci., EpiThany
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Cornerstone001: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (clinicaltrials.gov) -  Jun 16, 2024   
    P2,  N=10, Terminated, 
    Trial primary completion date: Oct 2023 --> Oct 2025 N=146 --> 10 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> May 2024; Difficulty in recruiting patients
  • ||||||||||  EP-201 / EpiThany, Aston Sci.
    AST-201 (pUMVC3-hIGFBP2 N-terminus) demonstrates anti-tumor effect in an ovarian cancer mouse model (Section 5) -  Mar 5, 2024 - Abstract #AACR2024AACR_6952;    
    P1, P2
    A study demonstrated that AST-201 (IGFBP2 cancer vaccine) showed an anti-tumor effect as mono treatment and would be potentially leading to a synergistic effect with a combination regimen of pembrolizumab. Phase 2 randomized-controlled study of AST-201 in ovarian cancer will be initiated under the MRCT strategy (CornerStone-004 study, NCT05794659).
  • ||||||||||  AST-05X / Aston Sci.
    AST-05X: A novel GCN2 inhibitor as a promising anti-cancer approach for sarcoma (Section 22) -  Mar 5, 2024 - Abstract #AACR2024AACR_3935;    
    In addition, based on the results of ISR-related gene expression profiling GEP analysis, we identified potential CDx biomarkers for evaluating the diagnosis and treatment response of sarcoma.Conclusion This study is currently investigating the efficacy of the drug in sarcoma patient-derived xenograft models. AST-05X is a GCN2 inhibitor that has the potential to validate the inhibition of GCN2 as a promising anti-cancer approach for sarcoma, a rare cancer with limited therapeutic alternatives.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, NTX-301 / PinotBio, Aston Sci.
    Novel Hypomethylating Agent Ntx-301 Exhibits Anti-Leukemia Activity in Venetoclax-Resistant and TP53-Mutant AML (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5587;    
    Additionally, NTX-301 treatment increased caspase-8 and cleaved-caspase-8 in AML cells independent of TP53 mutation status, consistence with reports showing caspase-8 hypermethylation in AML and supporting that activation of caspase-8-mediated extrinsic apoptosis as a mechanism of NTX-301 action. In conclusion, our data suggest that NTX-301 has more potent anti-leukemia activities compared to current HMA in clinic and synergizes with venetoclax in venetoclax-resistance and TP53-mutant AML and AML stem/progenitor cells, and warrants clinical evaluation
  • ||||||||||  EP-201 / EpiThany, Aston Sci.
    AST-201 (pUMVC3-hIGFBP2 N-terminus) demonstrates anti-tumor effect in an ovarian cancer mouse model (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1144;    
    P1, P2
    Conclusions A study demonstrated that AST-201 (IGFBP2 cancer vaccine) showed an anti-tumor effect as mono treatment and would be potentially leading to a synergistic effect with a combination regimen of pembrolizumab. Phase 2 randomized-controlled study of AST-201 in ovarian cancer will be initiated under the MRCT strategy (CornerStone-004 study, NCT05794659).
  • ||||||||||  AST-301 / University of Washington, Aston Sci., EpiThany
    Antitumor effect of HER2-hICD vaccine combining with HER2 ADC depending on T cell existence in a mouse model: pooled analysis (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_365;    
    P1
    Conclusions Given that clear antitumor effect of AST-301-based regimen was observed in CD34+ humanized mouse model than athymic BALB/c nude mouse model, it is proven that the presence of T cells is very crucial in pharmacological efficacy of cancer vaccine approach and relevant in-vivo efficacy study. These translational researches are supporting a clinical study of AST-301 combining with HER2-ADCs.
  • ||||||||||  NTX-301 / PinotBio, Aston Sci.
    Trial completion date, Trial primary completion date:  NTX-301 in MDS/AML (clinicaltrials.gov) -  Aug 8, 2023   
    P1,  N=20, Recruiting, 
    These translational researches are supporting a clinical study of AST-301 combining with HER2-ADCs. Trial completion date: Mar 2025 --> Mar 2028 | Trial primary completion date: Dec 2023 --> Dec 2027
  • ||||||||||  EP-202 / EpiThany, Aston Sci.
    Infiltrative Peripheral T-Cell Lymphoma: A Rare Cause of Acute Liver Failure (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_1546;    
    Figure 2: H&E x20X (image 2a) and CD7 (pan-T cell immunohistochemical stain) x20X (image 2b). Sections of a punch of skin show an unremarkable epidermis with perivascular and periadnexal collections of markedly atypical T cells.
  • ||||||||||  Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma, AST-301 / University of Washington, Aston Sci., EpiThany
    PSC in an Acutely Psychotic Patient (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_1499;    
    Sections of a punch of skin show an unremarkable epidermis with perivascular and periadnexal collections of markedly atypical T cells. He was found to have elevated liver enzymes
  • ||||||||||  AST-021p / Aston Sci.
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  AST-021p Study in Advanced Solid Tumors (clinicaltrials.gov) -  Jul 20, 2023   
    P1,  N=19, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Aug 2023
  • ||||||||||  NTX-301 / PinotBio, Aston Sci.
    Trial primary completion date:  NTX-301 in MDS/AML (clinicaltrials.gov) -  Feb 16, 2023   
    P1,  N=20, Recruiting, 
    This effort is focused on narrowing the administration doses to low levels to resolve the safety issue of ADC or ICI, and it will strongly support the diverse applicability of the cancer therapeutic vaccine. Trial primary completion date: Mar 2023 --> Dec 2023
  • ||||||||||  AST-302 / Aston Sci., EpiThany
    Enrollment closed, Trial completion date, Trial primary completion date:  MCC-19117: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (clinicaltrials.gov) -  Jan 11, 2023   
    P2,  N=119, Active, not recruiting, 
    Trial primary completion date: Mar 2023 --> Dec 2023 Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Dec 2026 | Trial primary completion date: Mar 2023 --> Dec 2025
  • ||||||||||  AST-021p / Aston Sci.
    Trial completion date, Trial primary completion date, Metastases:  AST-021p Study in Advanced Solid Tumors (clinicaltrials.gov) -  Jul 21, 2022   
    P1,  N=19, Recruiting, 
    D. Congo red stain 10X (2022): Apple-green birefringence under polarized light within sinusoids and portal tracts. Trial completion date: Feb 2023 --> Jul 2023 | Trial primary completion date: Oct 2022 --> Mar 2023
  • ||||||||||  AST-302 / Aston Sci., EpiThany
    Trial completion date, Trial primary completion date:  MCC-19117: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (clinicaltrials.gov) -  Apr 5, 2022   
    P2,  N=110, Recruiting, 
    No abstract available Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2023
  • ||||||||||  NTX-301 / PinotBio, Aston Sci.
    NTX301 targets platinum resistant ovarian cancer (E-Poster Website) -  Mar 9, 2022 - Abstract #AACR2022AACR_6927;    
    Treatment with NTX301 induced more significant downregulation of the DNA methyltransferases (DNMTs) 1-3 expression in SKOV3 and OVCAR5 cells compared with decitabine (p<0.05)...We next tested the effects NTX301 in cisplatin (CDDP) resistant OC cells, developed by repeated treatments with CDDP... Our data indicate that NTX301 is a potent HMA which targets ovarian CSCs and re-sensitizes OC cells to chemotherapy, supporting its further development in OC.