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- onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene, Blincyto (blinatumomab) / Astellas, Amgen
Combination therapy with the oncolytic virus CF33-CD19 and blinatumomab for the treatment of advanced solid tumors. (Hall A; Poster Bd #: 157a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3086;
P1
doi: 10.1126/scitranslmed.aaz1863. PMID: 32878978.
- VAXinia (CF33-hNIS) / Imugene
Oncolytic virus CF33-hNIS for the treatment of advanced cancer (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_6632;
PMID: 32878978. Abstract is embargoed at this time.
- || CHECKvacc (CF33-hNIS-antiPDL1) / Imugene
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Oncolytic virus, Metastases: CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Jan 4, 2024
P1, N=9, Active, not recruiting, Sponsor: City of Hope Medical Center
Abstract is embargoed at this time. Recruiting --> Active, not recruiting | N=78 --> 9 | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024
- || VAXinia (CF33-hNIS) / Imugene
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Oncolytic virus, Metastases: 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) - Dec 31, 2023
P1, N=100, Recruiting, Sponsor: Imugene Limited
- VAXinia (CF33-hNIS) / Imugene
Oncolytic virus CF33-hNIS monotherapy for the treatment of gastrointestinal (GI) malignancies. (Poster Bd # M4) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_322;
P1
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.
- ||| onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene
Enrollment open, Combination therapy, Metastases: A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov) - Oct 12, 2023
P1, N=52, Recruiting, Sponsor: Imugene Limited
Treatment with CF33-hNIS monotherapy was well tolerated and the study has advanced to examine combination therapy with pembrolizumab. Not yet recruiting --> Recruiting
- ||| onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene
New P1 trial, Combination therapy, Metastases: A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov) - Oct 2, 2023
P1, N=52, Not yet recruiting, Sponsor: Imugene Limited
- VAXinia (CF33-hNIS) / Imugene
A phase I safety and tolerability study of VAXinia (CF33-hNIS), a novel chimeric oncolytic poxvirus, administered intratumorally or intravenously in adults with metastatic or advanced solid tumors (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1063;
P1
4 This study will evaluate the safety and recommended Phase 2 dose (RP2D) of intratumoral (IT) and intravenous (IV) CF33-hNIS alone or in combination with pembrolizumab in advanced or metastatic solid tumors, after progression following ?2 prior lines of therapy. The study began enrolling patients in March 2022; IV monotherapy cohorts 1
- VAXinia (CF33-hNIS) / Imugene
Induction of an inflammatory tumor microenvironment with oncolytic virus CF33-hNIS-antiPD-L1 intratumoral injection in patients with metastatic triple-negative breast cancer (mTNBC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2094;
P1
Upregulation of PD-L1 within the TME further suggests immune activation by CHECKvacc. The clinical trial is ongoing to further assess dose escalation, tumor response, and the potential for future combination trials with systemic therapies, such as checkpoint blockade and chemotherapy.
- | VAXinia (CF33-hNIS) / Imugene
Preclinical, Journal, Oncolytic virus: An Oncolytic Poxvirus Encoding hNIS, Shows Antitumor Efficacy and Allows Tumor Imaging in a Liver Cancer Model. (Pubmed Central) - Jun 9, 2023
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.
- | VAXinia (CF33-hNIS) / Imugene
Preclinical, Journal, Oncolytic virus: An oncolytic poxvirus encoding hNIS, shows anti-tumor efficacy and allows tumor imaging in a liver cancer model. (Pubmed Central) - May 17, 2023
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.
- onCARlytics (CF33-CD19) / Imugene
Effective Combination Immunotherapy Using onCARlytics and Artemis (Board No. 586) - Apr 21, 2023 - Abstract #ASGCT2023ASGCT_1215;
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
- VAXinia (CF33-hNIS) / Imugene
hNIS imaging data from a first-in-human trial of the oncolytic virus CF33-hNIS-antiPD-L1 in patients with triple negative breast cancer (Section 44; Poster Board #4) - Mar 14, 2023 - Abstract #AACR2023AACR_8178;
Further analysis will evaluate the correlation of SPECT imaging results with pathologic immune cell infiltrate, viral staining, and tumor response. This is the first known report of hNIS-based imaging to track oncolytic poxvirus replication in humans and gives promise that this technology may be used for noninvasive tracking of systemically administered OV and other therapies.
- ||| VAXinia (CF33-hNIS) / Imugene
#Imugene's #HERVaxx & #CF33 platforms to be featured at #ASCOGI23 $IMU https://t.co/okjrGr0jml (Twitter) - Dec 17, 2022
- onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene
CF33-CD19t Oncolytic Virus (onCARlytics) in Combination with Off-the-shelf Allogeneic CyCART-19 T Cells Targeting de novo CD19+ Solid Tumors (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1159;
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.
- onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene
CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with Artemis CD19 T cells results in significant tumor killing (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_705;
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.
- onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene, Blincyto (blinatumomab) / Astellas, Amgen
Combination immunotherapy using a novel chimeric oncolytic virus to redirect CD19 bispecific T cell engagers to target solid tumors (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_642;
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.
- ||| VAXinia (CF33-hNIS) / Imugene
Enrollment open, Combination therapy, Monotherapy, Oncolytic virus, Metastases: 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) - May 26, 2022
P1, N=100, Recruiting, Sponsor: Imugene Limited
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. Not yet recruiting --> Recruiting
- VAXinia (CF33-hNIS) / Imugene
Phase I study of intratumoral administration of CF33-HNIS-antiPDL1 in patients with metastatic triple negative breast cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1274;
P1
Background: Despite recent FDA approval of immune checkpoint inhibitor pembrolizumab and drug-antibody conjugate in the treatment of metastatic triple negative breast cancer (mTNBC), the overall survival benefit of these therapies remains modest. This FIH trial of CF33-hNIS-antiPD-L1 intratumoral injection in patients with mTNBC is currently underway.
- ||| VAXinia (CF33-hNIS) / Imugene
New P1 trial, Combination therapy, Monotherapy, Oncolytic virus, Metastases: 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) - Apr 25, 2022
P1, N=100, Not yet recruiting, Sponsor: Imugene Limited
- | VAXinia (CF33-hNIS) / Imugene
Preclinical, Journal: A comprehensive preclinical study supporting clinical trial of oncolytic chimeric poxvirus CF33-hNIS-anti-PD-L1 to treat breast cancer. (Pubmed Central) - Jan 14, 2022
Finally, the in-use stability and compatibility of CF33-hNIS-anti-PD-L1 tested under different conditions mimicking the clinical scenarios confirmed the suitability of the virus in clinical settings. The results of these preclinical studies support the use of CF33-hNIS-anti-PD-L1 in a first-in-human trial in patients with TNBC.
- | CHECKvacc (CF33-hNIS-antiPDL1) / Imugene
Enrollment open, Oncolytic virus, Metastases: CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Nov 16, 2021
P1, N=78, Recruiting, Sponsor: City of Hope Medical Center
The results of these preclinical studies support the use of CF33-hNIS-anti-PD-L1 in a first-in-human trial in patients with TNBC. Not yet recruiting --> Recruiting
- | CHECKvacc (CF33-hNIS-antiPDL1) / Imugene
New P1 trial, Oncolytic virus, Metastases: CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Oct 17, 2021
P1, N=78, Not yet recruiting, Sponsor: City of Hope Medical Center