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- | TENDU Vaccine / Zelluna
Preclinical, Journal: Preclinical development and clinical safety assessment of a synthetic peptide conjugate enabling endogenous antibody binding to promote innate receptor engagement. (Pubmed Central) - Jun 16, 2025
Herein, we describe the generation of a prostate cancer vaccine candidate (TENDU) based on this technology...Transgenic humanized HLA-DR4 mice displayed T cell responses and increased anti-MTTE IgG levels after vaccination with a peptide construct including an HLA-DR4 epitope. The vaccine candidate was found safe, and a positive correlation between T cell responses and anti-MTTE antibodies was noted in the first-in-human study.
- UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
Multiomics profiling for prediction of immunotherapy response in advanced pleural mesothelioma: Sub-study of the NIPU trial. (Hall A - Posters and Exhibits; Poster Bd #: 207) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1560;
P2
High/positive levels of tumoral CD66b+ neutrophils show promise as predictive biomarkers for immunotherapy efficacy in advanced pleural mesothelioma. Larger, independent studies are needed to confirm these findings and validate their clinical utility.
- | Imfinzi (durvalumab) / AstraZeneca, UV1 / Zelluna, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial completion date, Trial primary completion date: DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov) - Jan 13, 2025
P2, N=184, Recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Larger, independent studies are needed to confirm these findings and validate their clinical utility. Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Dec 2026
- || UV1 / Zelluna
Trial completion: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - Dec 16, 2024
P1/2, N=18, Completed, Sponsor: Ultimovacs ASA
Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Dec 2026 Active, not recruiting --> Completed
- || UV1 / Zelluna
Trial completion: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov) - Dec 16, 2024
P1/2, N=22, Completed, Sponsor: Ultimovacs ASA
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || UV1 / Zelluna
Trial completion: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - Dec 16, 2024
P1/2, N=12, Completed, Sponsor: Ultimovacs ASA
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ZI-MA4-1 / Zelluna, UT MD Anderson Cancer Center
Development of the first optimised 'off the shelf' MAGE-A4 targeting TCR-NK cells for advancement into the clinic for the treatment of solid tumors (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1253;
Ethics Approval All ethical approval was obtained for this work. Use of human material was provided by the Regionale Komiteer for Medisinsk og helsefaglig forskningsetikk
- || UV1 / Zelluna
Trial completion, Trial completion date: UV1-103: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Aug 22, 2024
P1, N=30, Completed, Sponsor: Ultimovacs ASA
Use of human material was provided by the Regionale Komiteer for Medisinsk og helsefaglig forskningsetikk Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jun 2024
- ||| UV1 / Zelluna
Trial completion, Trial completion date, Trial primary completion date: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - Apr 18, 2024
P2, N=156, Completed, Sponsor: Ultimovacs ASA
Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jun 2024 Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Apr 2024 | Trial primary completion date: Apr 2024 --> Jan 2024
- ZI-MA4-1 / Zelluna, UT MD Anderson Cancer Center
Development of the first optimised "off the shelf" MAGE-A4 targeting TCR-NK cells for advancement into the clinic for the treatment of solid tumors (Section 2) - Mar 5, 2024 - Abstract #AACR2024AACR_4203;
Interestingly, we observe enhanced proliferation of ZI-MA4-1a cells after activation by MAGE-A4 expressing tumor cells, indicating that TCR-NK cells acquire further proliferative capacity when the TCR is triggered. Finally, we demonstrate higher activity of ZI-MA4-1a compared to KVL-a and benchmark TCR transduced T cells against antigen positive targets, and activity against antigen negative tumor cells escaping TCR-T cell recognition.
- || UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
Trial primary completion date, Tumor mutational burden: NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov) - Mar 2, 2024
P2, N=118, Active, not recruiting, Sponsor:
Finally, we demonstrate higher activity of ZI-MA4-1a compared to KVL-a and benchmark TCR transduced T cells against antigen positive targets, and activity against antigen negative tumor cells escaping TCR-T cell recognition. Trial primary completion date: Mar 2024 --> Mar 2025
- || UV1 / Zelluna
Enrollment closed, Trial completion date, Trial primary completion date: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - Nov 7, 2023
P2, N=154, Active, not recruiting, Sponsor: Ultimovacs ASA
Trial primary completion date: Mar 2024 --> Mar 2025 Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2026 | Trial primary completion date: Jun 2023 --> Apr 2024
- TCR-NK-X / Karolinska Institute, Zelluna, ZI-MA4-1 / Zelluna, UT MD Anderson Cancer Center
A novel (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_713;
Conclusions Taken together, these data demonstrate the feasibility and potential of generating optimised TCR-NK cells from PB-NK resulting in a highly potent cell product combining TCR-mediated and innate NK killing functions. Based on the potency and safety profile, ZI-MA4
- | Imfinzi (durvalumab) / AstraZeneca, UV1 / Zelluna, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial completion date, Trial primary completion date: DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov) - Sep 8, 2023
P2, N=184, Recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Based on the potency and safety profile, ZI-MA4 Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024
- || UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Tumor mutational burden: NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov) - Jan 25, 2023
P2, N=118, Active, not recruiting, Sponsor:
Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024 Recruiting --> Active, not recruiting
- | UV1 / Ultimovacs
Trial completion date, Metastases: UV1-103: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Nov 17, 2022
P1, N=30, Active, not recruiting, Sponsor: Ultimovacs ASA
Recruiting --> Active, not recruiting Trial completion date: Oct 2022 --> Oct 2025
- | Keytruda (pembrolizumab) / Merck (MSD), UV1 / Zelluna
Enrollment open, Trial initiation date: LUNGVAC: Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 18, 2022
P2, N=138, Recruiting, Sponsor: Vestre Viken Hospital Trust
Trial completion date: Oct 2022 --> Oct 2025 Not yet recruiting --> Recruiting | Initiation date: May 2022 --> Aug 2022
- || UV1 / Zelluna
Trial completion date, Trial primary completion date: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - Aug 17, 2022
P2, N=154, Recruiting, Sponsor: Ultimovacs ASA
Not yet recruiting --> Recruiting | Initiation date: May 2022 --> Aug 2022 Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Aug 2022 --> Jun 2023
- | Keytruda (pembrolizumab) / Merck (MSD), UV1 / Zelluna
New P2 trial: LUNGVAC: Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - Apr 25, 2022
P2, N=138, Not yet recruiting, Sponsor: Vestre Viken Hospital Trust
- | Imfinzi (durvalumab) / AstraZeneca, UV1 / Zelluna, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment open: DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov) - Jan 24, 2022
P2, N=184, Recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Aug 2022 --> Jun 2023 Not yet recruiting --> Recruiting
- |||| Keytruda (pembrolizumab) / Merck (MSD), UV1 / Zelluna
New P2 trial: FOCUS: Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab (clinicaltrials.gov) - Oct 11, 2021
P2, N=75, Recruiting, Sponsor: Martin-Luther-Universit
- | UV1 / Zelluna
Trial primary completion date: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - May 17, 2021
P1/2, N=12, Active, not recruiting, Sponsor: Ultimovacs ASA
Not yet recruiting --> Recruiting Trial primary completion date: Feb 2020 --> Feb 2025
- || UV1 / Ultimovacs
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: UV1-103: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Feb 21, 2021
P1, N=30, Active, not recruiting, Sponsor: Ultimovacs ASA
Trial primary completion date: Feb 2020 --> Feb 2025 Recruiting --> Active, not recruiting | N=20 --> 30 | Trial completion date: May 2021 --> Oct 2022 | Trial primary completion date: May 2020 --> Oct 2022
- | UV1 / Zelluna
Trial completion date: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - Feb 17, 2021
P2, N=154, Recruiting, Sponsor: Ultimovacs ASA
Recruiting --> Active, not recruiting | N=20 --> 30 | Trial completion date: May 2021 --> Oct 2022 | Trial primary completion date: May 2020 --> Oct 2022 Trial completion date: Sep 2022 --> Sep 2024
- | Imfinzi (durvalumab) / AstraZeneca, UV1 / Zelluna, Lynparza (olaparib) / Merck (MSD), AstraZeneca
New P2 trial: DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov) - Feb 4, 2021
P2, N=184, Not yet recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- ||| UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
Enrollment open, Tumor mutational burden: NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov) - Jun 29, 2020
P2, N=118, Recruiting, Sponsor:
Trial completion date: Sep 2022 --> Sep 2024 Not yet recruiting --> Recruiting
- ||| UV1 / Zelluna
Enrollment open: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - Jun 17, 2020
P2, N=154, Recruiting, Sponsor: Ultimovacs ASA
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| UV1 / Zelluna
New P2 trial: INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov) - May 10, 2020
P2, N=154, Not yet recruiting, Sponsor: Ultimovacs ASA
- || UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Tumor mutational burden: NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov) - Mar 20, 2020
P2, N=118, Not yet recruiting, Sponsor:
Not yet recruiting --> Recruiting Trial completion date: Mar 2030 --> Mar 2027 | Trial primary completion date: Mar 2028 --> Mar 2024
- |||| UV1 / Zelluna, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / BMS
New P2 trial, Tumor mutational burden: NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov) - Mar 9, 2020
P2, N=118, Not yet recruiting, Sponsor:
- | UV1 / Zelluna
Trial completion date, Trial primary completion date: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - May 7, 2019
P1/2, N=18, Active, not recruiting, Sponsor: Ultimovacs AS
Trial completion date: Mar 2030 --> Mar 2027 | Trial primary completion date: Mar 2028 --> Mar 2024 Trial completion date: Feb 2020 --> Apr 2023 | Trial primary completion date: Feb 2020 --> Apr 2023
- | UV1 / Zelluna
Trial completion date, Trial primary completion date: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov) - May 7, 2019
P1/2, N=21, Active, not recruiting, Sponsor: Ultimovacs AS
Trial completion date: Feb 2020 --> Apr 2023 | Trial primary completion date: Feb 2020 --> Apr 2023 Trial completion date: Jul 2020 --> Apr 2023 | Trial primary completion date: Jul 2020 --> Apr 2023
- | UV1 / Zelluna
Trial completion date, Trial primary completion date: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - May 7, 2019
P1/2, N=12, Active, not recruiting, Sponsor: Ultimovacs AS
Trial completion date: Jul 2020 --> Apr 2023 | Trial primary completion date: Jul 2020 --> Apr 2023 Trial completion date: Nov 2019 --> Feb 2025 | Trial primary completion date: Nov 2019 --> Feb 2020
- || UV1 / Ultimovacs
New P1 trial, Metastases: UV1-103: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Jun 3, 2018
P1, N=20, Recruiting, Sponsor: Ultimovacs AS
- | UV1 / Zelluna
Enrollment closed, Enrollment change, Trial primary completion date: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - Jan 26, 2017
P1/2, N=12, Active, not recruiting, Sponsor: Ultimovacs AS
Trial completion date: Nov 2019 --> Feb 2025 | Trial primary completion date: Nov 2019 --> Feb 2020 Recruiting --> Active, not recruiting | N=20 --> 12 | Trial primary completion date: Nov 2016 --> Nov 2019
- UV1 / Zelluna
Trial primary completion date: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - Nov 7, 2016
P1/2, N=18, Active, not recruiting, Sponsor: Ultimovacs AS
Recruiting --> Active, not recruiting | N=20 --> 12 | Trial primary completion date: Nov 2016 --> Nov 2019 Trial primary completion date: Jul 2016 --> Feb 2020
- UV1 / Zelluna
Trial primary completion date: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov) - Nov 7, 2016
P1/2, N=21, Active, not recruiting, Sponsor: Ultimovacs AS
Trial primary completion date: Jul 2016 --> Feb 2020 Trial primary completion date: Jul 2015 --> Jul 2020
- UV1 / Zelluna
Trial primary completion date: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - Apr 7, 2016
P1/2, N=18, Active, not recruiting, Sponsor: Ultimovacs AS
Trial primary completion date: Jul 2015 --> Jul 2020 Trial primary completion date: Mar 2016 --> Jul 2016
- | UV1 / Zelluna
Enrollment closed, Trial primary completion date: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - Jan 6, 2016
P1/2, N=21, Active, not recruiting, Sponsor: Ultimovacs AS
Trial primary completion date: Mar 2016 --> Jul 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2015 --> Mar 2016
- | UV1 / Zelluna
Enrollment open: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - Dec 10, 2014
P1/2, N=20, Recruiting, Sponsor: Ultimovacs AS
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2015 --> Mar 2016 Not yet recruiting --> Recruiting
- UV1 / Zelluna
Enrollment closed, Trial primary completion date: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov) - Dec 9, 2014
P1/2, N=21, Active, not recruiting, Sponsor: Ultimovacs AS
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2015 --> Jul 2015
- | UV1 / Zelluna
New P1/2 trial: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov) - Oct 27, 2014
P1/2, N=20, Not yet recruiting, Sponsor: Ultimovacs AS
- UV1 / Zelluna
New P1/2 trial: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov) - Feb 7, 2013
P1/2, N=21, Recruiting, Sponsor: Oslo University Hospital
- UV1 / Zelluna
New P1/2 trial: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov) - Feb 4, 2013
P1/2, N=21, Recruiting, Sponsor: Oslo University Hospital