UV1 Cancer Vaccine Description
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. As opposed to algorithm-selected vaccine peptides, the UV1 peptides contain epitopes documented by cancer patients' immune systems.
Immune responses against several hTERT epitopes, including novel hTERT epitopes not present in the vaccines given, were detected in blood samples from long-term surviving patients following vaccine treatment, but not in patients without clinical benefit.
Based on these data, three hTERT peptides to elicit strong T cell responses across different cancer types were selected as the UV1 vaccine components.
UV1 is being developed as a therapeutic cancer vaccine, which may serve as a platform for use combined with other immunotherapy that requires an ongoing T cell response for their mode of action.
UV1's unique mechanism of action has the potential to be applicable across most cancer types.
UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor's growth and microenvironment.
UV1 consists of long, synthetic peptides shown to induce CD4+ T cells displaying a Th1 cytokine profile. By directing the immune system to hTERT antigens present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade to increase anti-tumor responses.
UV1 Cancer Vaccine News
December 22, 2020 - Ultimovacs ASA - Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab. The FOCUS trial is Ultimovacs' fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.
December 10, 2020 - Ultimovacs ASA announced positive five-year Overall Survival (OS) data from the Phase I trial evaluating the company's universal cancer vaccine, UV1, combined with the checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma. After 5-years of follow-up, 50% of the patients in the open-label trial were still alive, providing encouraging signals of long-term survival benefit for UV1 in this late-stage patient population and as compared to historical data of ipilimumab monotherapy.
November 2, 2020 - Ultimovacs ASA announced the acceptance of publication in Frontiers in Immunology, outlining the positive long-term follow-up data from the company's Phase I trial evaluating its proprietary universal cancer vaccine, UV1, in non-small cell lung cancer. In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as a maintenance treatment.
June 15, 2020 - Ultimovacs ASA announced that the first patient had been dosed in the global, randomized Phase II INITIUM clinical trial testing Ultimovacs' lead candidate, UV1, in combination with ipilimumab and nivolumab in 154 patients with metastatic malignant melanoma.
February 4, 2020 - Study: Combining UV1 and ipilimumab is safe and induces clinical melanoma responses. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism. OS compares favorably to historical controls. Clinical trial information: NCT02275416. Results: 12 patients were treated from Feb to Nov 2015. Treatment was generally well-tolerated. Adverse events mainly included injection site reactions and diarrhea. Immune responses occurred very early, and 10/11 evaluable patients showed an immune response. Three patients obtained a partial response, and one patient a complete response. 3-year overall survival (OS) was 67%. 4-year survival outcome will be presented along with baseline characteristics and TMB estimations.
UV1 Cancer Vaccine Clinical Trials
To date, UV1 has been tested in four-phase I/II clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
Clinical Trial NCT02275416: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma. Last Update Posted: May 7, 2019.
This is a phase I/IIa, a national, open-label, single-arm, interventional study examining safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma. Patients that have signed the informed consent form will be asked to take part in the study.
All patients will receive ipilimumab together with the UV1 vaccine and rranulocyte-macrophage colony-stimulating factor (GM-CSF). Ipilimumab will be given every 3rd week for a total of 4 doses.
The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab. The maximum number of UV1/GM-CSF will be 10 doses.
Immunoresponders maybe followed up every third month for 5 years after the first UV1 treatment. Follow-up is ongoing.
Clinical Trial NCT01789099: A Phase I/IIa Study of UV1 Vaccination in Patients With Non-Small Cell Lung Cancer. (UV1-hTERT2012L). Last Update Posted: May 7, 2019.
In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1, as well as immunological response, will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials. Study recruitment was completed at 6 patients at every dose level.
Clinical Trial NCT01784913: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P). Last Update Posted: May 7, 2019.
In this Phase 1/2a study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1, as well as immunological response, will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
The main treatment period is completed and reported. Follow-up is ongoing.