Ultimovacs - UV1 ODD a sign of positive things to come
Ultimovacs has announced that the US FDA has granted orphan drug designation (ODD) to its cancer vaccine, UV1, for the treatment of mesothelioma. This is a positive development as the orphan designation is based on initial clinical data from the investigator-led Phase II NIPU clinical trial, which did not meet its primary end point of progression-free survival (PFS) in June 2023; however, it indicated a positive trend in overall survival (OS) in the UV1 arm. While the company is gearing up to share updated dataset (especially OS data) for NIPU at the upcoming ESMO Congress from 20–24 October, we believe the ODD indicates UV1’s potential in mesothelioma and might be helpful in further discussions with the US FDA. In our view, the upcoming readouts from the ongoing Phase II trials, including the next INITIUM (malignant melanoma) top-line results in H124, represent major catalysts for the company.Ultimovacs ASA Formerly known as Ultimovacs AS. Ultimovacs ASA, formerly Ultimovacs AS, is a Norway-based pharmaceutical company developing immunotherapies against cancer. The Company's lead product candidate is UV1, 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 immuno-oncology drugs which require an ongoing T cell response for their mode of action. The Company is performing a broad clinical development program with clinical trials in Europe and the USA.
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