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Ultimovacs Receives EMA Orphan Drug Designation for UV1 Cancer Vaccine for the Treatment of Mesothelioma | ||
By: GlobeNewswire - 19 Feb 2024 | Back to overview list |
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Oslo, February 19, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the company’s application for Orphan Drug Designation (ODD) for its therapeutic cancer vaccine UV1 for the treatment of mesothelioma. The designation was granted based on results from the Phase II clinical trial, NIPU evaluating UV1 added to ipilimumab and nivolumab treatment in patients with malignant pleural mesothelioma. “The EMA’s Orphan Drug Designation for UV1 in mesothelioma is an important step forward in the development of our cancer vaccine in this indication,” said Carlos de Sousa, CEO of Ultimovacs. “It allows for important regulatory and commercial benefits and provides us with the potential to rapidly advance UV1 for a patient population with poor prognosis and a high unmet medical need.” To qualify for orphan designation in the EU, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition affecting fewer than five in 10,000 people in the EU, based on data that support that the investigational medicine may produce clinically significant benefits over existing treatments. ODD provides companies with certain benefits and incentives, including ten years of market exclusivity upon reaching the market, clinical protocol assistance, access to a centralized marketing authorization procedure, and reduced regulatory fees. Mesothelioma is a rare and aggressive form of cancer with a high mortality rate and few therapeutic options. Patients with mesothelioma commonly have a history of occupational or environmental exposure to asbestos, and it typically takes decades for this specific form of cancer to develop. The impact of UV1 vaccination in patients with malignant pleural mesothelioma has been evaluated in a randomized Phase II clinical trial, NIPU. In the study, UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and compared to ipilimumab and nivolumab alone as a second-line treatment, after first-line treatment with platinum-based chemotherapy. The results from the study, presented at the European Society for Molecular Oncology (“ESMO”) Congress 2023, demonstrated a clinically meaningful improvement in overall survival for UV1 treatment in combination with ipilimumab and nivolumab versus ipilimumab and nivolumab alone. In addition, UV1 maintained its positive safety and tolerability profile in this combination with no added toxicities. Oslo University Hospital sponsored the NIPU study with support from Bristol Myers Squibb and Ultimovacs. On February 5, 2024, the FDA granted Fast Track designation for UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival. In October 2023, UV1 received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with mesothelioma. In December 2021, the FDA granted Orphan Drug Designation for UV1 for the treatment of stage IIB-stage IV melanoma. In October 2021, the FDA granted Fast Track designation for UV1 as add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma. ==ENDS== About NIPU
Mesothelioma is a rare and aggressive type of cancer that occurs in the thin layer of tissue that surrounds the lungs and inside of the chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in 2020, according to International Agency for Research on Cancer (Globocan 2020). Pleural mesothelioma is a disease with a high unmet medical need, especially in industrialized countries. The median overall survival is approximately one year. Occupational asbestos exposure is the No. 1 cause of the disease, and several occupations, like firefighters, military veterans, construction, and industry workers, are at risk. This cancer usually takes several decades to develop after a person’s first exposure to asbestos. Most patients are diagnosed after age 70 because of the long latency period. Even though the use of asbestos to a large extent is banned in many countries today, new incidences of mesothelioma will continue to be a medical and public health challenge because of the long latency period typical of the illness. For patients with inoperable disease, few treatment options are available after first-line chemotherapy. The combination of ipilimumab and nivolumab has recently shown increased survival compared to standard chemotherapy, but most patients do not respond, and improvements are called for. Telomerase is expressed in mesothelioma cells and is therefore a relevant target for therapeutic vaccination. About Ultimovacs
About UV1 The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is therefore not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months as eight intradermal injections together with the immune-modulator GM-CSF. For further information, please see www.ultimovacs.com or contact: Carlos de Sousa, CEO Anne Worsøe, Head of IR 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. |
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