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DRUG:

UV1

i
Other names: UV1, UV-1, UV1 synthetic peptide vaccine, UV 1, UV1 telomerase peptide vaccine, UV1/hTERT peptide vaccine
Associations
Company:
Ultimovacs
Drug class:
Immunostimulant, hTERT inhibitor
Related drugs:
Associations
3ms
UV1-103: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
P1, N=30, Completed, Ultimovacs ASA | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jun 2024
Trial completion • Trial completion date • Metastases
|
BRAF (B-raf proto-oncogene)
|
Keytruda (pembrolizumab) • UV1
7ms
INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov)
P2, N=156, Completed, Ultimovacs ASA | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Apr 2024 | Trial primary completion date: Apr 2024 --> Jan 2024
Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
9ms
NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov)
P2, N=118, Active, not recruiting, Åslaug Helland | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date • Tumor mutational burden
|
TMB (Tumor Mutational Burden)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
9ms
Tolerability and efficacy of the cancer vaccine UV1 in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - the randomized phase 2 FOCUS trial. (PubMed, Front Oncol)
The FOCUS study aims to optimize treatment of R/M HNSCC patients with this promising new treatment approach. https://clinicaltrials.gov/study/NCT05075122, identifier NCT05075122.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • UV1
1year
Bridging responses to a human telomerase reverse transcriptase-based peptide cancer vaccine candidate in a mechanism-based model. (PubMed, Int Immunopharmacol)
A high baseline SLD and a high relative increase from nadir were identified as main predictors for a reduced OS in NSCLC and MM patients, respectively. Our model predictions highlighted that additional maintenance doses, i.e. UV1 administration for longer periods, may result in more sustained tumor size shrinkage.
Journal
|
TERT (Telomerase Reverse Transcriptase) • CD4 (CD4 Molecule)
|
UV1
1year
INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov)
P2, N=154, Active, not recruiting, Ultimovacs ASA | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2026 | Trial primary completion date: Jun 2023 --> Apr 2024
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
1year
DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov)
P2; Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
Myriad myChoice® CDx
|
Lynparza (olaparib) • Imfinzi (durvalumab) • UV1
over1year
Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Advanced Melanoma: Results from a Phase I Trial. (PubMed, Clin Cancer Res)
Encouraging safety and preliminary efficacy were observed. Randomized phase II trials are currently ongoing.
P1 data • Journal • Metastases
|
CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Leukine (sargramostim) • UV1
over1year
First survival data from the NIPU trial: A randomised, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second-line treatment in patients with malignant mesothelioma (ESMO 2023)
Supportive analyses indicate an increased ORR and clinically meaningful prolonged survival in the intervention arm. The results warrant confirmation in a larger clinical trial.
Clinical • P2 data • Late-breaking abstract
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • UV1
over1year
Impact of hTERT peptide vaccine combined with androgen deprivation therapy and radiotherapy in de novo metastatic prostate cancer: Long-term clinical monitoring. (PubMed, Int J Cancer)
Twenty-two men with ISUP 4 to 5 and lymph node and/or bone metastases were treated with androgen deprivation therapy (ADT), radiotherapy and the hTERT vaccine UV1 between January 2013 and July 2014...The long-term monitoring showed that some patients had unanticipated subsequent high immune responses without developing recurrence. This association indicates that there might be a clinical benefit of hTERT vaccination in a subgroup of men with primary metastatic hormone-sensitive prostate cancer treated with ADT and radiotherapy.
Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • Metastases
|
TERT (Telomerase Reverse Transcriptase)
|
UV1
2years
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
P1, N=30, Active, not recruiting, Ultimovacs ASA | Trial completion date: Oct 2022 --> Oct 2025
Trial completion date • Metastases
|
BRAF (B-raf proto-oncogene)
|
Keytruda (pembrolizumab) • UV1
2years
Characterization of the T cell receptor repertoire and melanoma tumor microenvironment upon combined treatment with ipilimumab and hTERT vaccination. (PubMed, J Transl Med)
Clinical responses were observed irrespective of established predictive biomarkers for checkpoint inhibitor efficacy, indicating an added benefit of the vaccine-induced T cells. The clinical and immunological read-out warrants further investigation of UV1 in combination with checkpoint inhibitors. Trial registration Clinicaltrials.gov identifier: NCT02275416. Registered October 27, 2014. https://clinicaltrials.gov/ct2/show/NCT02275416?term=uv1&draw=2&rank=6.
Journal • Tumor Mutational Burden • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma)
|
Yervoy (ipilimumab) • UV1
over2years
Durable and dynamic hTERT immune responses following vaccination with the long-peptide cancer vaccine UV1: long-term follow-up of three phase I clinical trials. (PubMed, J Immunother Cancer)
Long-term immunomonitoring of patients showed highly dynamic and persistent telomerase peptide-specific immune responses lasting up to 7.5 years after the initial vaccination, suggesting a plausible functional role of these T cells in long-term survivors. The superior immune response kinetics observed in the melanoma study substantiate the rationale for future combinatorial treatment strategies with UV1 vaccination and checkpoint inhibition for rapid and frequent induction of anti-telomerase immune responses in patients with cancer.
P1 data • Journal
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
|
Yervoy (ipilimumab) • UV1
3years
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma)
|
Keytruda (pembrolizumab) • Leukine (sargramostim) • UV1
3years
The synthetic long peptide cancer vaccine UV1 in combination with ipilimumab induces a CD4+ Th1 anti-hTERT immune response and an inflammatory tumor microenvironment in patients with melanoma (SITC 2021)
Conclusions UV1 in combination with ipilimumab leads to robust and long-lasting CD4+ Th1 anti-hTERT immune responses sculpting the local tumor microenvironment. Trial Registration NCT02275416
Clinical • Combination therapy
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
|
Yervoy (ipilimumab) • UV1
over3years
Combining a Universal Telomerase Based Cancer Vaccine With Ipilimumab in Patients With Metastatic Melanoma - Five-Year Follow Up of a Phase I/IIa Trial. (PubMed, Front Immunol)
The rapid expansion of UV1-specific Th1 cells in the majority of patients indicates synergy between UV1 vaccine and CTLA-4 blockade. This may have translated into clinical benefit, encouraging the combination of UV1 vaccination with standard of care treatment regimes containing ipilimumab/CTLA-4 blocking antibodies.
Clinical • P1/2 data • Journal
|
TERT (Telomerase Reverse Transcriptase) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
|
Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
over3years
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
P1, N=30, Active, not recruiting, Ultimovacs ASA | Recruiting --> Active, not recruiting | N=20 --> 30 | Trial completion date: May 2021 --> Oct 2022 | Trial primary completion date: May 2020 --> Oct 2022
Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene)
|
Keytruda (pembrolizumab) • UV1
almost5years
A phase I/IIa clinical trial investigating the therapeutic cancer vaccine UV1 in combination with ipilimumab in patients with malignant melanoma: Four-year survival update. (ASCO-SITC 2020)
Combining UV1 and ipilimumab is safe and induces clinical responses in melanoma. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism. OS compares favorably to historical controls.
Clinical • P1/2 data • Combination therapy • Tumor Mutational Burden • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
|
Yervoy (ipilimumab) • UV1
almost5years
A phase I/IIa clinical trial investigating the therapeutic cancer vaccine UV1 in combination with ipilimumab in patients with malignant melanoma: Four-year survival update. (ASCO-SITC 2020)
Combining UV1 and ipilimumab is safe and induces clinical responses in melanoma. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism. OS compares favorably to historical controls.
Clinical • P1/2 data • Combination therapy • Tumor Mutational Burden • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
|
Yervoy (ipilimumab) • UV1