- |||||||||| mipetresgene autoleucel (TBI-1301) / Takara
Trial completion date, Trial primary completion date: Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov) - Dec 8, 2023
P1, N=22, Active, not recruiting,
Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1 positive tumor cells appears to be a promising strategy for the treatment of advanced or recurrent synovial sarcoma with acceptable toxicity. Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, canerpaturev (TBI-1401) / Takara
Review, Journal, IO biomarker: New Treatment Horizons in Uveal and Cutaneous Melanoma. (Pubmed Central) - Aug 26, 2023
Furthermore, combining oncolytic viruses with immunotherapies, such as CAR-T cell therapy, holds great potential. Understanding the intrinsic molecular features of melanoma and their role in shaping novel therapeutic approaches provides insights into targeted interventions and paves the way for more effective treatments for CM and UM.
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Trial completion, Trial completion date: Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose) (clinicaltrials.gov) - Nov 9, 2022
P1/2, N=422, Completed,
This study may provide insights into the mechanism of action of OV therapy plus metformin combination against various tumor models. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Sep 2022
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Trial primary completion date: Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose) (clinicaltrials.gov) - Jul 21, 2022
P1/2, N=400, Active, not recruiting,
Regarding immunogenicity, a cellular immune response was observed in some subjects after AG0302-COVID19 intradermal inoculation, but no significant antibody production was observed. Trial primary completion date: Mar 2022 --> Dec 2021
- |||||||||| canerpaturev (TBI-1401) / Takara, Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Clinical, Preclinical, Journal, IO biomarker: S-1 facilitates canerpaturev (C-REV)-induced antitumor efficacy in a triple-negative breast cancer model. (Pubmed Central) - Feb 8, 2022
S-1, an oral formulation containing the 5-fluorouracil (5-FU) prodrug tegafur and the two enzyme modulators gimeracil and oteracil, is used as a key chemotherapeutic agent for metastatic recurrent breast cancer...Our study suggests that MDSCs may be an important cellular target for breast cancer treatment. The combination of C-REV and S-1 is a new approach that might be directly translated into future clinical trials against TNBC.
- |||||||||| Oncorine (recombinant human adenovirus type 5) / Mergen Ltd., canerpaturev (TBI-1401) / Takara
Retrospective data, Review, Journal, Oncolytic virus: The efficacy and safety of oncolytic viruses in the treatment of intermediate to advanced solid tumors: a systematic review and meta-analysis. (Pubmed Central) - Feb 5, 2022
A total of 22 studies involving 3,996 patients were included in this analysis, including 13 H101 studies, 5 T-VEC studies, 2 Pexa-Vec studies, 1 HF10 study and 1 Reolysin study...The adverse events (AEs) associated with the other OVs mainly included fever, nausea and vomiting, leukopenia, and hypotension. OVs are effective and well tolerated for the treatment of intermediate to advanced solid cancer and represent a promising therapeutic approach for solid cancers.
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Enrollment closed: Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose) (clinicaltrials.gov) - Oct 5, 2021
P1/2, N=400, Active, not recruiting,
Future studies to assess effects on viremia and latent proviral reservoir are warranted. Recruiting --> Active, not recruiting
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Trial completion: Study of COVID-19 DNA Vaccine (AG0302-COVID19) (clinicaltrials.gov) - Oct 4, 2021
P1/2, N=30, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| canerpaturev (TBI-1401) / Takara
Biomarker, Journal, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker: Oncolytic herpes simplex virus HF10 (canerpaturev, C-REV) promotes accumulation of CD8 PD-1 tumor-infiltrating T cells in PD-L1- enriched tumor microenvironment. (Pubmed Central) - Sep 8, 2021
In addition, changes in expression of TIM-3 and TIGIT were not observed on CD8 TILs after C-REV treatment. Taken together, our findings may reveal mechanisms that allow oncolytic viruses to trigger an antitumor immune response, irrespective of a PD-L1-enriched tumor microenvironment, by recruitment of CD8 PD-1 TILs.
- |||||||||| AG0301-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine, Fresh Tracks Therap
Trial completion: Study of COVID-19 DNA Vaccine (AG0301-COVID19) (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=30, Completed,
Taken together, our findings may reveal mechanisms that allow oncolytic viruses to trigger an antitumor immune response, irrespective of a PD-L1-enriched tumor microenvironment, by recruitment of CD8 PD-1 TILs. Active, not recruiting --> Completed
- |||||||||| canerpaturev (TBI-1401) / Takara
Journal, IO biomarker: Oncolytic activity of HF10 in head and neck squamous cell carcinomas. (Pubmed Central) - Jul 28, 2021
The HF10-treated mice that survived their original tumor burdens rejected tumor cells upon re-challenge. These results suggested that HF10 killed HNSCC cells and induced antitumoral immunity, thereby establishing it as a promising agent for the treatment of HNSCC patients.
- |||||||||| Review, Journal: Current status of intralesional agents in treatment of malignant melanoma. (Pubmed Central) - Jul 20, 2021
This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
- |||||||||| Review, Journal: Intratumoral Immunotherapy-Update 2019. (Pubmed Central) - Jun 22, 2021
In 2019, a multitude of intratumoral immunotherapies with varied mechanisms of action, including nononcolytic viral therapies such as PV-10 and toll-like receptor 9 agonists and oncolytic viral therapies such as CAVATAK, Pexa-Vec, and HF10, have been extensively evaluated in clinical trials and demonstrated promising antitumor activity with tolerable toxicities in melanoma and other solid tumor types...This review summarizes current knowledge on intratumoral therapies, a novel modality with increased utility in cancer treatment, and T-VEC, the only U.S. FDA-approved oncolytic viral therapy, for medical oncologists. This review evaluates approaches to incorporate T-VEC into daily practice to offer the possibility of response in selected melanoma patients with manageable adverse events as compared with other available immunotherapies.
- |||||||||| TBI 1201 / Takara
Trial completion, Enrollment change, Trial primary completion date: Investigator Initiated Phase 1 Study of TBI-1201 (clinicaltrials.gov) - Jun 18, 2021
P1, N=18, Completed,
This review evaluates approaches to incorporate T-VEC into daily practice to offer the possibility of response in selected melanoma patients with manageable adverse events as compared with other available immunotherapies. Recruiting --> Completed | N=12 --> 18 | Trial primary completion date: Jun 2018 --> Mar 2021
- |||||||||| canerpaturev (TBI-1401) / Takara
Review, Journal, Oncolytic virus: Oncolytic Viruses for the Treatment of Metastatic Melanoma. (Pubmed Central) - Jun 12, 2021
Data comparing T-VEC in combination with PD-1 checkpoint inhibitors is awaited, and a phase III trial is underway. It is likely that oncolytic viruses will have long-term application in the treatment of melanoma and that T-VEC in particular will continue to have a role in the treatment of patients with readily accessible cutaneous lesions both for local control and synergistic induction of antitumor immunity as part of combination therapies.
- |||||||||| mipetresgene autoleucel (TBI-1301) / Takara
Trial completion date, Trial primary completion date: Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov) - Apr 22, 2021
P1, N=22, Recruiting,
It is likely that oncolytic viruses will have long-term application in the treatment of melanoma and that T-VEC in particular will continue to have a role in the treatment of patients with readily accessible cutaneous lesions both for local control and synergistic induction of antitumor immunity as part of combination therapies. Trial completion date: Jan 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> Sep 2021
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Enrollment closed: Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19) (clinicaltrials.gov) - Feb 18, 2021
P2/3, N=500, Active, not recruiting,
We successfully established an oral cancer cell line and showed that HF10 is a promising therapeutic agent for oral cancer. Recruiting --> Active, not recruiting
- |||||||||| canerpaturev (TBI-1401) / Takara, Opdivo (nivolumab) / BMS
Trial termination, Combination therapy, Oncolytic virus: Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (clinicaltrials.gov) - Nov 3, 2020
P2, N=7, Terminated,
Trial completion date: Mar 2020 --> Mar 2035 | Trial primary completion date: Mar 2019 --> Mar 2035 Active, not recruiting --> Terminated; DSMC Recommendation
- |||||||||| AG0302-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine
Enrollment closed: Study of COVID-19 DNA Vaccine (AG0302-COVID19) (clinicaltrials.gov) - Sep 24, 2020
P1/2, N=30, Active, not recruiting,
Trial completion date: Jul 2020 --> Jan 2034 Recruiting --> Active, not recruiting
- |||||||||| AG0301-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine, Fresh Tracks Therap
Enrollment closed: Study of COVID-19 DNA Vaccine (AG0301-COVID19) (clinicaltrials.gov) - Aug 23, 2020
P1/2, N=30, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| AG0301-COVID19 / Takara, AnGes MG, Osaka University Graduate School of Medicine, Fresh Tracks Therap
New P1/2 trial: Study of COVID-19 DNA Vaccine (AG0301-COVID19) (clinicaltrials.gov) - Jul 8, 2020
P1/2, N=30, Recruiting,
- |||||||||| canerpaturev (TBI-1401) / Takara
S-1 Facilitates C-REV Induced Anti-Tumor Efficacy in Triple Negative Breast Cancer Mode () - May 9, 2020 - Abstract #ASGCT2020ASGCT_40;
Canerpaturev (C-REV) is a highly attenuated, replication-competent mutant strain of oncolytic herpes simplex virus type 1...Considering that MDSC is known as the cells to suppress both innate and adaptive immune responses, the combination could induce a systemic antitumor immune response. From our result, S-1 is expected to be a promising agent in combination with C-REV in TNBC.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO Biomarker: Targeted Therapy and Immunotherapy for Melanoma in Japan. (Pubmed Central) - Mar 26, 2020
In the adjuvant setting, dabrafenib plus trametinb combination, nivolumab monotherapy, and pembrolizumab monotherapy were approved in July, August, and December 2018 in Japan, respectively...A phase III trial of adjuvant therapy with locoregional interferon (IFN)-β versus surgery alone is ongoing in Japan (JCOG1309, J-FERON), in which IFN-β is injected directly into the site of the primary tumor postoperatively, so that it would be drained through the untreated lymphatic route to the regional node basin...In conclusion, acral and mucosal melanomas have been treated based on the available medical evidence for the treatment of non-acral cutaneous melanomas. Considering the differences in genetic backgrounds and therapeutic efficacy of immunotherapy, specialized therapeutic strategies for these subtypes of melanoma should be established in the future.
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