At the end of October, announced Ultimovacs that you have been granted double Fast Track-designation by the US Food and Drug Administration FDA for its universal cancer vaccine UV1The decision was based on positive phase I data from two separate studies by the Norwegian biotech company. The studies tested UV1 in combination with two different checkpoint inhibitors, pembrolizumab (Keytruda) and ipilimumab (Yervoy), in patients with unresectable or metastatic melanoma.
The latest survival data regarding the combination treatment UV1/pembrolizumab shows an overall survival of 80 percent after 24 months in a group of 20 patients with metastatic melanoma. Read more here. At the same time, survival data regarding the UV1/ipilimumab combination, published in Frontiers in Immunology in May of this year, an overall survival of 50 percent after 5 years of follow-up of a total of 12 patients with metastatic malignant melanoma.
Orphan drug designation for UV1
Audio BioStock earlier reported The Fast Track decision was likely to pave the way for further regulatory benefits for Ultimovac's universal cancer vaccine. Last week, barely a month later, the company announced that UV1 had been granted orphan drug designation (Orphan Drug Designation, ODD) for the treatment of melanoma in stages IIB – IV.
This is a significant milestone that brings several regulatory benefits to Ultimovacs, including seven years of market exclusivity upon regulatory approval. In addition, it provides both an exemption from FDA application fees and tax credits for qualified clinical trials. Read more in BioStocks Article Series on Drug Development.
Ultimovac CEO Carlos de Sousa was very pleased to have reached another milestone:
»We are very pleased to have been granted this orphan drug designation for UV1 in treating metastatic melanoma. The designation underlines the promise of UV1 that has been shown in our clinical studies in metastatic melanoma to date. We remain committed to further investigating UV1 in our ongoing Phase II clinical studies and to continuing our constructive dialogue with regulators to bring UV1 to patients as soon as possible.«
Positive momentum for a broad Phase II pipeline
Based on the promising Phase I results, Ultimovacs has begun evaluating UV1 in a Phase II clinical study called INITIALThis study is investigating the safety and efficacy of UV1 in combination with ipilimumab and another checkpoint inhibitor nivolumab (Wonderful), in malignant melanoma patients. The results regarding the study's primary endpoint are expected in the second half of 2022.
The FDA's orphan drug designation gives Ultimovac new momentum and increased confidence as it continues its extensive clinical development program. INITIUM is one of five ongoing or imminent Phase II studies of UV1 in combination with various checkpoint inhibitors. The studies cover a broad spectrum of cancer indications, including ovarian cancer. (DOVAC study), squamous cell carcinoma (FOCUS study), malignant pleural mesothelioma (NIPU study) and non-small cell lung cancer (LUNG VAC). The LUNGVAC study is the most recently initiated Phase II study for which recruitment is expected to begin in H1 2022. Read more here.
In total, the five Phase II studies will enroll more than 650 patients at nearly 100 clinical centers in 15 countries. Ultimovacs expects to present data on the primary endpoints of the NIPU and INITIUM studies in the second half of 2022 and the DOVACC and FOCUS studies indicate a timeline for results readout in 2023.
