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DRUG:

VAXinia (CF33-hNIS)

i
Other names: CF33-hNIS, HOV2
Associations
Company:
Imugene
Drug class:
T-cell stimulant
Associations
1m
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)
11ms
Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Metastases
|
PD-L1 expression
|
Keytruda (pembrolizumab) • VAXinia (CF33-hNIS)
12ms
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)
1year
Enrollment open • Combination therapy • Metastases
|
Blincyto (blinatumomab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
over1year
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
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HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
|
VAXinia (CF33-hNIS)
over1year
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)
over1year
Effective Combination Immunotherapy Using onCARlytics and Artemis® CD19 T Cells Against Hepatocellular Carcinoma (HCC) (ASGCT 2023)
Currently, there are six systemic therapies available for patients with advanced disease including atezolizumab in combination with bevacizumab, lenvatinib, regorafenib, cabozantinib and ramucirumab while curative treatments include ablation, surgical resection, and liver transplantation...We have harnessed this capability of OV and developed a chimeric vaccinia-based OV called CF33-CD19t (onCARlytics) that delivers a non-signaling, truncated CD19 (CD19t) antigen to solid tumors allowing CD19-specific T cells to target them...In addition, this combination approach demonstrated impressive in vivo anti-tumor responses in a human xenograft HepG2 tumor model. By using this combination OV and CAR T cell strategy, we have now broadened the utility of CD19 ARTEMIS® T cells to otherwise target-less tumors such as HCC, which we anticipate can be applied to a wide array of solid cancers as an effective immunotherapy approach.
PD(L)-1 Biomarker • IO biomarker
|
CD19 (CD19 Molecule) • AFP (Alpha-fetoprotein) • GPC3 (Glypican 3)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Lenvima (lenvatinib) • Cabometyx (cabozantinib tablet) • Stivarga (regorafenib) • Cyramza (ramucirumab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
2years
CF33-CD19t Oncolytic Virus (onCARlytics) in Combination with Off-the-shelf Allogeneic CyCART-19 T Cells Targeting de novo CD19+ Solid Tumors (SITC 2022)
This combination approach demonstrated impressive in vivo anti-tumor response in human tumor xenograft models. Conclusions In summary, our results have demonstrated that further development of this combination immunotherapy for the potential treatment of a wide array of solid tumors is warranted.
Combination therapy • Oncolytic virus
|
CD19 (CD19 Molecule)
|
CD19 expression
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VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
2years
CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with Artemis CD19 T cells results in significant tumor killing (SITC 2022)
For majority of patients with advanced-stage disease, treatment with agents such as sorafenib, lenvatinib, and atezolizumab/bevacizumab and other investigational agents yield modest success rates and justify the need for further development of new therapies. Results When administrated after onCARlytics, CD19 ARTEMIS® T cells were able to induce potent cytolytic activity against HCC tumor cells and demonstrated robust in vivo anti-tumor efficacy against human HCC tumor xenografts. Conclusions In summary, ARTEMIS® CD19 T cells combined with onCARlytics is a potentially effective immunotherapy strategy for the treatment of patients with HCC and can be applied to other solid tumors.
Combination therapy • Oncolytic virus
|
CD19 (CD19 Molecule) • AFP (Alpha-fetoprotein) • GPC3 (Glypican 3)
|
CD19 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • Lenvima (lenvatinib) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
2years
Combination immunotherapy using a novel chimeric oncolytic virus to redirect CD19 bispecific T cell engagers to target solid tumors (SITC 2022)
Building on this, we generated an OV that expresses a non-signaling, truncated CD19 antigen (CF33-CD19t or onCARlytics, in collaboration with Imugene Limited), onto the surface of infected tumor cells prior to virus mediated tumor lysis, which redirected CD19-targeting chimeric antigen receptor (CAR) T cell activity against solid tumors (Park et al . Results Tumors infected with CF33-CD19t along with blinatumomab show specific tumor cell killing in vitro and robust anti-tumor efficacy using in vivo human triple-negative breast cancer xenograft models. Conclusions Using this approach, we show that a clinically-approved CD19-directed BiTE can be combined with oncolytic viruses to activate and redirect endogenous anti-tumor immunity against solid tumors.
Oncolytic virus
|
CD19 (CD19 Molecule)
|
Blincyto (blinatumomab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)