On November 2, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), reported 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 (Press release, Ultimovacs, NOV 2, 2020, View Source [SID1234569710]). The publication will cover detailed outcomes of the study for the 18 patients receiving UV1 monotherapy as maintenance treatment.
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"Today’s acceptance of publication in Frontiers in Immunology supports our goal to raise UV1 awareness among the scientific and medical communities through publications and presentations at medical conferences," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "Continued positive signs of safety and tolerability are of great importance for us as we are currently evaluating UV1 in triple combinations in two Phase II studies and safety remains our primary focus as we develop treatments for patients in need."
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 maintenance treatment. Patients were assigned to three different dose-groups, of 100, 300 and 700 µg, with each cohort enrolling 6 patients. Data in the publication with a cut-off date of March 2020, demonstrated that administration of UV1 resulted in specific T-cell responses in the majority of the patients. The highest dose of 700 µg, resulted in the highest proportion of immune responses. In addition, immune responses in the high-dose cohort were stronger, occurred at an earlier timeframe and were associated with long survival. The 4-year overall survival (OS) for the patients in the highest cohort was 83%, as compared to 39% for the total patient group.
"The acceptance of our publication is a recognition of the confidence we have in UV1 as a universal cancer vaccine that could potentially treat a range of cancer indications," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "The data in the publication together with the 5-year topline results that we announced last month, confirm that UV1 can potentially benefit patients with non-small cell lung cancer. In all four Phase I trials that Ultimovacs has conducted with UV1, we see promising overall survival outcomes that support our ongoing, extensive clinical development program for UV1."
The abstract of the publication is available here: https://www.frontiersin.org/articles/10.3389/fimmu.2020.572172/abstract, the full article can be accessed after publication at the Frontiers in Immunology website: www.frontiersin.org.
About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes three randomized, multinational, Phase II combination trials recruiting more than 400 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.