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Ultimovacs Receives Dual FDA Fast Track Designation for UV1 in Advanced Malignant Melanoma
OSLO, Norway, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage leader in immune stimulatory vaccines for cancer, announced its universal cancer vaccine, UV1, in combination with checkpoint inhibitors has received Fast Track designation from the U.S. FDA in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM. Ultimovacs senior management will host a webcast on the Fast Track designation and the supporting clinical data at 13.00 CET on Thursday, October 21. The FDA Fast Track process is designed to facilitate the development and expedite the review of drugs that meet urgent needs in serious medical conditions. Fast Track designation enables early and frequent communication with the FDA to support the drug’s development, as well as entitlement to a Rolling Review of the Biologic License Application. Drugs with Fast Track designation may also be considered for Accelerated Approval and Priority Review provided certain criteria are met. “We are delighted UV1 has received the Fast Track designation and look forward to working more closely with the FDA to bring UV1 to melanoma patients as soon as possible,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs. “The FDA’s ecision recognizes the potential synergy of UV1 and checkpoint inhibitors and will greatly encourage physicians and patients involved in our Phase II clinical trial INITIUM. We remain committed to progressing UV1 in our four ongoing Phase II clinical studies and assessing development of UV1 with pembrolizumab in advanced melanoma.” The Fast Track designation is based on data from two separate Phase I trials of UV1 in combination with checkpoint inhibitors, either with pembrolizumab (anti-PD-1) or with ipilimumab (anti-CTLA-4). According to data disclosed recently, UV1 in combination with pembrolizumab as a first-line treatment in advanced melanoma was shown to be safe with promising early efficacy data; an objective response rate (ORR) of 57% was reached with 30% of patients achieving a complete response (CR), or complete disappearance of their tumors. At 24 months follow up, 80% of patients were alive. In a second cohort, similar levels of tumor destruction were seen with 90% of patients remained alive after one year. Peer-reviewed data published in May 2021 in Frontiers in Immunology demonstrated that UV1 with ipilimumab was safe and showed signals of prolonged efficacy in advanced melanoma, the combination achieving ORR of 33% and 5-year overall survival (OS) rate of 50%. UV1 is currently being investigated in combination with checkpoint inhibitors in four Phase II trials: in unresectable or metastatic melanoma, ovarian cancer, head and neck squamous cell carcinoma and malignant pleural mesothelioma. Ultimovacs’ webcast on the Fast Track designation and clinical data at 13.00 CET (7.00 am EST) on Thursday, 21 October 2021 will be accessible here and from the company website. About Ultimovacs For further information, please see www.ultimovacs.com or contact: Carlos de Sousa, CEO Hans Vassgård Eid, CFO Mary-Ann Chang, LifeSci Advisors This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act. This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on October 21, 2021 at 08:00 CET. |