RARE Daily

FDA Grants Fast Track to Ultimovacs’ Vaccine for Unresectable Mesothelioma

February 5, 2024

Rare Daily Staff

The U.S. Food and Drug Administration granted Fast Track designation to Norwegian biotech Ultimovacs’ therapeutic cancer vaccine UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival, including first-line patients.

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.

Ultimovacs’ lead candidate, UV1, is an off-the-shelf therapeutic cancer vaccine directed against human telomerase (hTERT), an antigen present in 85-90 percent of cancers in all stages of tumor growth.

“We are pleased that the FDA has granted Fast Track designation for UV1 in two separate advanced indications, which underlines the potential of our cancer vaccine approach,” said Carlos de Sousa, CEO of Ultimovacs. “UV1 demonstrated a positive safety profile and encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions with the goal of bringing important new drugs earlier to patients. The Fast Track designation enables Ultimovacs to have more frequent interactions with the FDA to discuss the UV1 development path for the treatment of mesothelioma.

The designation was granted based on results from the phase 2 clinical trial, NIPU, which evaluated UV1 in patients with unresectable malignant pleural mesothelioma. 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 ESMO Congress in October 2023, demonstrated a clinically meaningful improvement in overall survival for UV1 with no added toxicities. They showed that UV1, as an add-on to ipilimumab and nivolumab, demonstrated a clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone. A total of 31 percent of the patients receiving the UV1 vaccine experienced an objective response, compared to 16 percent in the control arm. The investigator-initiated trial is led by Oslo University Hospital and supported by Bristol Myers Squibb and Ultimovacs.

Ultimovacs expects to announce topline results from the randomized phase 2 trial INITIUM in March and plans to report data from its broad UV1 phase 2 clinical trial program with UV1 over the course of 2024 and beyond.

In October 2023, UV1 received FDA Orphan Drug designation for the treatment of 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 an add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma.

Photo: Carlos de Sousa, CEO of Ultimovacs

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