UV1 Cancer Vaccine Description For 2022
Ultimovacs's UV1 is a peptide-based vaccine inducing a specific T-cell response against the universal cancer antigen telomerase. As a universal cancer vaccine, UV1's unique mechanism of action can be applicable to most cancer types. Unlike algorithm-selected vaccine peptides, the UV1 peptides contain epitopes documented by cancer patients' immune systems. In addition, the UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to effectively across the dynamic stages of the tumor's growth and microenvironment.
Immune responses against several hTERT epitopes, including novel hTERT epitopes not present in the vaccines, were detected in blood samples from long-term surviving patients following vaccine treatment but not in patients without clinical benefit. Based on these data, threehTERT peptides to elicit robust 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. In addition, UV1's unique mechanism of action can be applicable to most cancer types. UV1 consists of long, synthetic peptides that 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.
Building on Phase I results, Ultimovacs is enrolling INITIUM, its Phase II clinical trial evaluating UV1 combined with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The Company expects to announce data on the trial's primary endpoint in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 combined with pembrolizumab, a PD-1 checkpoint inhibitor, as a first-line treatment in metastatic malignant melanoma patients. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and the DOVACC and FOCUS studies in 2023.
Clinical analyses from the UV1-103 study announced on October 18, 2022, indicate efficacy in patients with low levels of PD-L1, a key predictive biomarker associated with lower efficacy for pembrolizumab, and other anti-PD-1 therapies, in some tumor types. In addition, the analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status.
In addition to the sub-analysis of the PD-L1 status, the study also evaluated four other key prognostic biomarkers, including baseline tumor mutational burden (TMB), predicted neoantigens, interferon-gamma (IFN-gamma) gene signature, and levels of tumor-infiltrating lymphocytes. The analyses of each of these five biomarkers signal efficacy in patients treated with UV1 in combination with pembrolizumab, regardless of the tumor phenotype.
Oslo, Norway-based Ultimovacs is a pharmaceutical company (OSE ULTI) developing novel immunotherapies against cancer. The lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase and immune activation for a prostate cancer-specific therapeutic. The Company's clinical studies are listed here.
UV1 Cancer Vaccine Indication
Ultimovacs has a long-standing commitment to the development of UV1-based treatments for melanoma. Malignant melanoma is a skin cancer with a significant and unmet medical need for improved treatments. More than 130,000 new cases of melanoma are diagnosed worldwide every year, and an estimated 50,000 people die from metastatic melanoma every year.
UV1 Cancer Vaccine News For 2021 - 2022
October 25, 2022 - Ultimovacs ASA announced that the first patient had been randomized in the LUNGVAC study. The study in non-small cell lung cancer is the fifth Phase II clinical trial in which UV1 is being investigated in combination with checkpoint inhibitors.
October 18, 2022 - Ultimovacs ASA presented clinical endpoints and biomarker results from patients in the UV1-103 Phase I trial.
June 30, 2022 - Ultimovacs ASA announces the completed recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs' Phase II clinical trial of its universal cancer vaccine UV1 combined with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM's event-driven design, topline progression-free survival results will be disclosed after the progression of cancer or death has been observed in 70 patients.
February 17, 2022 - Ultimovacs ASA announced its fourth-quarter 2021 results. A private placement was completed on October 26, 2021, raising gross proceeds of MNOK 270 (net MNOK 259.0).
December 15, 2021 - Ultimovacs ASA announced that the first patient had been enrolled in a randomized Phase II clinical trial (DOVACC) assessing the impact of the UV1 telomerase vaccine on ovarian cancer's standard of maintenance care. Topline data from DOVACC is expected in 2023.
December 2, 2021 - Ultimovacs ASA announced that the U.S. FDA had granted orphan drug designation for the Company's universal cancer vaccine UV1 to treat stage IIB – IV melanoma. UV1, as an add-on therapy to checkpoint inhibitors ipilimumab and nivolumab. UV1 is currently being studied as a first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.
November 11, 2021 - Ultimovacs ASA announced its third-quarter 2021 results. Highlights for the third quarter of 2021: Ultimovacs reported that UV1 would be investigated in a Phase II clinical trial in combination with pembrolizumab in non-small cell lung cancer; A private placement was completed on 26 October 2021, raising gross proceeds of MNOK 270; Total cash and cash equivalents were reduced by MNOK32.9 during Q3-21 and amounted to MNOK 347.8 as per 30 September 2021.
November 9, 2021 - The Company announced UV1 vaccine combined with ipilimumab was found in a clinical trial to induce immune responses in 91% of melanoma patients. And the immune responses persist and are detectable for up to 5 years.
October 26, 2021 - Ultimovacs announced that UV1 would be investigated in a Phase II clinical trial with pembrolizumab in non-small cell lung cancer (NSCLC). The LUNGVAC trial will be a multi-center, randomized, open-label trial sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll approximately 138 patients and be conducted at 8-10 clinical centers in Norway.
October 21, 2021 - Ultimovacs ASA announced its universal cancer vaccine, UV1, combined with checkpoint inhibitors, has received Fast Track designation from the U.S. FDA to treat unresectable or metastatic melanoma as an add-on therapy to pembrolizumab or as an add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as an add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.
October 13, 2021 - Ultimovacs ASA announced continuing positive topline clinical trial results in its ongoing U.S.-based Phase I clinical trial evaluating the Company's universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma. The trial had previously reached its primary endpoint of safety and tolerability and, at 24 months of follow-up, continues to demonstrate strong signs of clinical response. The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months.
October 12, 2021 - The Board of Directors of Ultimovacs ASA resolved to increase the Company's share capital by NOK 5,850 through the issuance of 58,500 new shares, each with a par value of NOK 0.10. The resolution is based on an authorization to increase the share capital granted by the Company's general meeting on 15 April 2021.
August 20, 2021 - The Company posted the 'Enabling the Immune System to Fight Cancer' presentation - Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma. And announced its second-quarter 2021 results.
August 12, 2021 - Ultimovacs ASA announced positive topline results from the second cohort of 10 patients after one year of its ongoing U.S.-based Phase I clinical trial evaluating the Company's universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma. The primary endpoint of safety and tolerability was achieved with strong initial signs of clinical response.
August 5, 2021 - Ultimovacs ASA announced that the first patient had been enrolled in FOCUS, an investigator-led Phase II randomized clinical trial in head-and-neck cancer of the Company's telomerase cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab.
June 1, 2021 - Ultimovacs announced a peer-reviewed article published in The Journal of Translational Medicine that outlines the mechanistic rationale for using the combination of UV1 with two checkpoint inhibitors, ipilimumab, and nivolumab. The dual use of ipilimumab and nivolumab was recently approved as first-line therapy in malignant pleural mesothelioma (MPM), with few therapeutic options available. However, as Haakensen et al. explains in the article, observed response rates with checkpoint inhibitors have been moderate in MPM compared to documented performance for the combination of checkpoint inhibitors in other cancers, suggesting that checkpoint inhibitors alone may be insufficient to trigger an immune response.
May 19, 2021 - Ultimovacs ASA announced that its universal cancer vaccine, UV1, combined with the checkpoint inhibitor pembrolizumab, demonstrated a 60% objective response rate (ORR) in metastatic malignant melanoma. All patients have been observed for at least 18 months, and the median observation time is 21 months.
May 11, 2021 - Ultimovacs ASA announced the publication in Frontiers in Immunology of its positive long-term Overall Survival data from the Phase I trial evaluating the Company's universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma. As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company's proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor, and standard-of-care treatment, in this late-stage patient population.
April 28, 2021 - Ultimovacs ASA announced that an abstract on the Company's Phase I trial evaluating its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the American Society of Clinical Oncology 2021 Annual Meeting to be held virtually Friday, June 4, 2021.
December 22, 2020 - Ultimovacs ASA - Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, 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 data from the Phase I trial evaluating the Company's universal cancer vaccine, UV1, combined with the checkpoint inhibitor ipilimumab for 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 benefits 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, 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.
UV1 Cancer Vaccine Clinical Trials
UV1 has been tested in several clinical trials and maintained a positive safety and tolerability profile and encouraging efficacy signals.
The LUNGVAC study is designed to assess the impact of UV1 in combination with standard-of-care immunotherapy, the anti-PD1 checkpoint inhibitor pembrolizumab. Topline data read-out from LUNGVAC is anticipated by the end of 2024. The primary endpoint of the trial will be progression-free survival. Secondary endpoints will include overall survival, response rate, duration of response and safety. The principal investigator for LUNGVAC is Professor Odd Terje Brustugun, a leading oncologist in the Nordic region with active involvement in multiple international lung cancer clinical trials.
Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Unresectable Melanoma: University of Iowa Holden Comprehensive Cancer Center.
Ultimovacs ASA - positive topline results from the first cohort of 20 patients in its ongoing US-based Phase I clinical trial evaluating the Company's lead candidate, UV1, combined with a PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The results confirm the achievement of the primary endpoints of safety and tolerability and indicate initial signs of clinical response.
UV1 is being tested in different randomized Phase II trials: The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma; The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, as second-line treatment in mesothelioma. In addition, a third Phase II clinical trial will evaluate UV1 in a new cancer indication combined with indication-specific standard of care cancer therapies different from those tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients).
