^
    1m
    REVOLUTION: Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=45, Completed, Cancer Insight, LLC | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Jul 2025
    Trial completion • Trial completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • albumin-bound paclitaxel • hydroxychloroquine • NG-350A
    4ms
    Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY) (clinicaltrials.gov)
    P1, N=198, Active, not recruiting, Akamis Bio | Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: Mar 2025 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • NG-350A
    7ms
    FORTRESS: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, Akamis Bio | Not yet recruiting --> Recruiting
    Enrollment open
    |
    capecitabine • NG-350A
    12ms
    FORTRESS: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Akamis Bio | Initiation date: Nov 2024 --> Feb 2025
    Trial initiation date • Combination therapy • Metastases • Viral vector
    |
    capecitabine • NG-350A
    1year
    First-in-human clinical outcomes with NG-350A, an anti-CD40 expressing tumor-selective vector designed to remodel immunosuppressive tumor microenvironments. (PubMed, J Immunother Cancer)
    This phase 1a study provided initial proof-of-mechanism for NG-350A, with strong evidence of tumor delivery, viral replication and transgene expression-particularly after intravenous dosing. The lack of transgene-related or off-target viral toxicity was consistent with the highly selective delivery and replication of NG-350A, even after systemic delivery. The efficacy of intravenous-dosed NG-350A will now be evaluated in combination with pembrolizumab (NCT05165433), as well as with chemoradiotherapy (NCT06459869).
    Clinical data • P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    CD40 expression
    |
    Keytruda (pembrolizumab) • NG-350A
    over1year
    Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY) (clinicaltrials.gov)
    P1, N=198, Active, not recruiting, Akamis Bio | Recruiting --> Active, not recruiting | Phase classification: P1a/1b --> P1
    Enrollment closed • Phase classification • Combination therapy • Metastases • Viral vector
    |
    Keytruda (pembrolizumab) • NG-350A
    over1year
    FORTRESS: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Akamis Bio
    New P1 trial • Combination therapy • Metastases • Viral vector
    |
    capecitabine • NG-350A
    2years
    REVOLUTION: Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Parker Institute for Cancer Immunotherapy | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • albumin-bound paclitaxel • hydroxychloroquine • NG-350A
    over2years
    Safe and effective delivery of antibody fragments to the solid tumor microenvironment (AACR 2023)
    NG-350A is currently being evaluated in phase I clinical studies in combination with Pembrolizumab or Ipilimumab. Data from these studies with initial vectors encoding combinations of functionally active antibody fragments will be presented. Collectively, these clinical and preclinical datasets demonstrate the broad utility of the T-SIGn platform for expressing rationally-designed combinations of antibodies and other natural and synthetic agents within tumors and thus enabling the development of new and potent immunotherapies for patients with solid epithelial cancers.
    PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • IL17A (Interleukin 17A)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • NG-350A