{"id":404197,"date":"2020-12-22T02:16:21","date_gmt":"2020-12-22T07:16:21","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=404197"},"modified":"2020-12-22T02:16:21","modified_gmt":"2020-12-22T07:16:21","slug":"ultimovacs-asa-initiates-focus-phase-ii-trial-for-universal-cancer-vaccine-uv1-in-head-and-neck-cancer-patients-receiving-pembrolizumab","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ultimovacs-asa-initiates-focus-phase-ii-trial-for-universal-cancer-vaccine-uv1-in-head-and-neck-cancer-patients-receiving-pembrolizumab\/","title":{"rendered":"Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab"},"content":{"rendered":"

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Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab<\/b><\/p>\n

OSLO, Norway–(BUSINESS WIRE<\/a>)–Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company\u2019s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs\u2019 fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. <\/b><\/p>\n

\u201cWe continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights,\u201d <\/i>stated Jens Bj\u00f8rheim, Chief Medical Officer at Ultimovacs.<\/b>\u201cProfessor Binder and her team are well-recognized experts who will increase our understanding of UV1\u2019s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.\u201d <\/i><\/p>\n

\nThe FOCUS (F<\/b>irst-line metastatic O<\/b>r recurrent HNSCC\/C<\/b>heckpoint inhibitor U<\/b>V1 S<\/b>tudy)<\/b> Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage.\n<\/p>\n

\u201cThis clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,\u201d <\/i>commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle.<\/b> \u201cI am excited to apply my own insights as well as my team\u2019s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options.\u201d <\/i><\/p>\n

\u201cWe have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time,\u201d <\/i>said Carlos de Sousa, Chief Executive Officer at Ultimovacs<\/b>. \u201cWe welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations.\u201d <\/i><\/p>\n

Dr. de Sousa added:<\/i><\/b> \u201cAlthough we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end.\u201d <\/i><\/p>\n

About UV1
\n
<\/b>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.\n<\/p>\n

About UV1 Clinical Programs
\n
<\/b>As a universal cancer vaccine, UV1\u2019s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials recruiting more than 450 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. The fourth trial, FOCUS, is an investigator-sponsored, randomized clinical trial, enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, to evaluate the impact of adding UV1 to this regimen.\n<\/p>\n

About Ultimovacs
\n
<\/b>Ultimovacs\u2019 UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor\u2019s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs\u2019 strategy is to clinically demonstrate UV1\u2019s impact in a range of cancers and in several immunotherapy combinations while expanding our pipeline of cancer vaccine therapies, convinced that a universal approach may be the key to achieving better outcomes for patients.\n<\/p>\n

\nFor further information, please see www.ultimovacs.com<\/a><\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201221005819\/en\/<\/a><\/span><\/p>\n

Carlos de Sousa, Chief Executive Officer
\n<\/b>
Email: carlos.desousa@ultimovacs.com
\n<\/a>
Phone: +47 908 92507\n<\/p>\n

Hans Vassg\u00e5rd Eid, Chief Financial Officer
\n<\/b>
Email: hans.eid@ultimovacs.com
\n<\/a>
Phone: +47 482 48632\n<\/p>\n

KEYWORDS:<\/b> Europe Norway Germany<\/p>\n

INDUSTRY KEYWORDS:<\/b> Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
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Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab OSLO, Norway–(BUSINESS WIRE)–Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company\u2019s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their … <\/p>\n

Continue reading “Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-404197","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nUltimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ultimovacs-asa-initiates-focus-phase-ii-trial-for-universal-cancer-vaccine-uv1-in-head-and-neck-cancer-patients-receiving-pembrolizumab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab OSLO, Norway–(BUSINESS WIRE)–Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company\u2019s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. 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