^
    20d
    A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
    P1, N=25, Terminated, Imugene Limited | N=50 --> 25 | Trial completion date: May 2029 --> Feb 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2027 --> Feb 2026; Portfolio prioritization
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Blincyto (blinatumomab) • hydroxyurea • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
    21d
    MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=66, Terminated, Imugene Limited | N=100 --> 66 | Trial completion date: Nov 2026 --> Jan 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Jan 2026; Portfolio prioritization
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • VAXinia (CF33-hNIS)
    3ms
    MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Active, not recruiting, Imugene Limited | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • VAXinia (CF33-hNIS)
    3ms
    A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Imugene Limited | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Blincyto (blinatumomab) • hydroxyurea • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
    10ms
    MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Imugene Limited | Trial completion date: Jan 2025 --> Nov 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • VAXinia (CF33-hNIS)
    12ms
    A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
    P1, N=50, Recruiting, Imugene Limited | N=33 --> 50
    Enrollment change
    |
    Blincyto (blinatumomab) • hydroxyurea • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
    over1year
    A Study of OnCARlytics (CF33-CD19) in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
    P1, N=33, Recruiting, Imugene Limited | N=52 --> 33 | Trial completion date: Sep 2025 --> May 2029 | Trial primary completion date: Sep 2024 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Blincyto (blinatumomab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
    2years
    MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Imugene Limited
    Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Metastases
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • VAXinia (CF33-hNIS)
    over2years
    Oncolytic virus CF33-hNIS monotherapy for the treatment of gastrointestinal (GI) malignancies. (ASCO-GI 2024)
    CF33-hNIS can replicate within cholangiocarcinoma lesions, as shown by SPECT imaging, and drive immunological changes known to promote antitumor immunity. CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies, including cholangiocarcinoma, a rare disease with an unmet medical need. Treatment with CF33-hNIS monotherapy was well tolerated and the study has advanced to examine combination therapy with pembrolizumab.
    Oncolytic virus
    |
    Keytruda (pembrolizumab) • VAXinia (CF33-hNIS)
    over2years
    A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
    P1, N=52, Recruiting, Imugene Limited | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Blincyto (blinatumomab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
    almost3years
    An Oncolytic Poxvirus Encoding hNIS, Shows Antitumor Efficacy and Allows Tumor Imaging in a Liver Cancer Model. (PubMed, Mol Cancer Ther)
    Finally, PET scanning was performed following injection of the radioisotope I-124, for imaging of tumors, and a single dose of virus as low as 1E03 pfu, administered intra-tumorally or intravenously, allowed for PET imaging of tumors. In conclusion, CF33-hNIS is safe and effective in controlling human tumor xenografts in nude mice, and it also facilitates noninvasive imaging of tumors.
    Preclinical • Journal • Oncolytic virus
    |
    HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    VAXinia (CF33-hNIS)
    almost3years
    An oncolytic poxvirus encoding hNIS, shows anti-tumor efficacy and allows tumor imaging in a liver cancer model. (PubMed, Mol Cancer Ther)
    Lastly, PET scanning was performed following injection of the radioisotope I-124, for imaging of tumors, and a single dose of virus as low as 1E03 pfu, administered intratumorally (I.T.) or intravenously (I.V.), allowed for PET imaging of tumors. In conclusion, CF33-hNIS is safe and effective in controlling human tumor xenografts in nude mice, and it also facilitates non-invasive imaging of tumors.
    Preclinical • Journal • Oncolytic virus
    |
    HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    VAXinia (CF33-hNIS)