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    DRUG:

    ACE1702

    i
    Other names: ACE1702, anti-HER2 oNK cells
    Company:
    Acepodia, JW (Cayman) Therap
    Drug class:
    HER2 inhibitor
    Related drugs:
    14d
    ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov)
    P1, N=12, Completed, Acepodia Biotech, Inc. | Recruiting --> Completed | N=36 --> 12
    Trial completion • Enrollment change • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    cyclophosphamide • fludarabine IV • ACE1702
    over2years
    ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Acepodia Biotech Inc. | Trial completion date: Jul 2022 --> Jun 2024 | Trial primary completion date: Jan 2022 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    HER-2 expression
    |
    cyclophosphamide • fludarabine IV • ACE1702
    over3years
    ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Acepodia Biotech Inc. | N=24 --> 36
    Clinical • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    HER-2 expression
    |
    fludarabine IV • ACE1702 • cyclophosphamide intravenous
    over3years
    [VIRTUAL] ACE1702, a first-in-class, off-the-shelf, selected natural killer cell [oNK] product using antibody cell conjugation technology [ACC], with pre-clinical and early clinical activity in HER2 < 3+ tumors (ESMO 2021)
    In pre-clinical studies, ACE1702 exhibited cancer-specific cytotoxicity and superior potency against low HER2 tumors. Preliminary data in pts showed no CRS, GvHD, or DLTs through doses of 3B cells/cycle and antitumor activity in a HER2 < 3+ tumor. Dose escalation continues up to 15B cells/cycle with updated clinical data to be provided.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL10 (Interleukin 10)
    |
    ACE1702
    over3years
    A Novel off-the-Shelf Trastuzumab-Armed NK Cell Therapy (ACE1702) Using Antibody-Cell-Conjugation Technology. (PubMed, Cancers (Basel))
    The irradiated and cryopreserved ACE-oNK-HER2, designated as ACE1702, retained superior HER2-specific in vitro and in vivo potency with no tumorigenic potential. In conclusion, this study provides the evidence to support the potential clinical application of ACE1702 as a novel off-the-shelf NK cell therapy against HER2-expressing solid tumors.
    Journal
    |
    IFNG (Interferon, gamma)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • ACE1702
    4years
    [VIRTUAL] A potent and off-the-shelf oNK cell therapy product targets HER2+ cancer cells and resists suppressive tumor microenvironment (SITC 2020)
    Conclusions Here we introduced a novel trastuzumab-modified oNK cell product with enhanced specificity against myriad types of HER2+ cancers. Selective conjugation of trastuzumab with membrane proteins contributing to NK activation conferred ACE1702 with enhanced cytotoxicity even in the suppressive tumor microenvironment.
    Late-breaking abstract
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • ACE1702
    4years
    [VIRTUAL] A potent and off-the-shelf oNK cell therapy product targets HER2+ cancer cells and resists suppressive tumor microenvironment (SITC 2020)
    Conclusions Here we introduced a novel trastuzumab-modified oNK cell product with enhanced specificity against myriad types of HER2+ cancers. Selective conjugation of trastuzumab with membrane proteins contributing to NK activation conferred ACE1702 with enhanced cytotoxicity even in the suppressive tumor microenvironment.
    Late-breaking abstract
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • ACE1702
    over4years
    ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov)
    P1, N=24, Recruiting, Acepodia Biotech Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    HER-2 expression
    |
    fludarabine IV • ACE1702 • cyclophosphamide intravenous
    over4years
    [VIRTUAL] ACE1702: A potent and off-the-shelf oNK cell therapy product (AACR-II 2020)
    In this work, we develop a NK cell therapy product ACE1702, a novel NK cell line oNK conjugated with Trastuzumab, and assess its potency against HER2+ solid tumors.MethodsoNK cells, a fluorescence-activated cell sorting (FACS) isolated CD16+ population sorted from NK-92 cells, was covalently conjugated with monoclonal antibody Trastuzumab after sublethal irradiation by our patented antibody-cell conjugates (ACCTM) platform to become our cryopreserved final product ACE1702 compliant with current good manufacturing practice (cGMP). Furthermore, in vivo results in human ovarian cancer cell line SK-OV-3-bearing xenograft mouse model supported the in vitro observations. Compared to other immunotherapeutic strategies such as antibody-drug conjugate, allogeneic NK and chimeric antigen receptor (CAR) modification, ACCTM platform underscores its power in compatibility with diverse antibodies, ease for mass production compliant with good manufacturing practice and affordability to patients.ConclusionHere we introduced a novel Trastuzumab-modified oNK cell product with enhanced specificity against myriad types of HER2+ cancers even in the presence of Herceptin resistance, and demonstrated the non-tumorigenic potential of non-irradiated oNK cells and ACE1702.
    IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • ACE1702 • Neukoplast (CST-101)
    over4years
    ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Acepodia Biotech Inc.
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    HER-2 expression
    |
    fludarabine IV • ACE1702 • cyclophosphamide intravenous