Ultimovacs has implemented cash-saving strategies, including a 40% workforce reduction, to extend its reserves into Q4 2025.
The operational adjustments are expected to provide a cash runway beyond the anticipated top-line readout from the next two Phase II trials – the FOCUS trial in Q3 this year, and the DOVACC trial in H1 2025.
The UV1 cancer vaccine development programme has suffered some setbacks. The company has reported topline data from two Phase II trials, NIPU and INITIUM, for the vaccine used in combination with PD1 inhibitors in two cancer indications, with both trials failing to meet primary endpoints.
The Phase II NIPU trial (NCT04300244) evaluated UV1 in combination with Bristol Myers Squibb’s checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) as a second-line treatment in mesothelioma patients. The study failed to meet its primary endpoint of progression-free survival (PFS).
The Phase II INITIUM trial (NCT02275416) also evaluated the UV1, Opdivo and Yervoy combination but in patients with unresectable or metastatic malignant melanoma. The study also failed to meet primary endpoints, with the company deciding to stop pursuing the therapy in this indication.
Despite this, Ultimovacs expects positive readouts from the next two trials. The Phase II FOCUS trial (NCT05075122) evaluates the combination treatment of UV1 vaccine with MSD’s Keytruda (pembrolizumab) as a first-line treatment in patients with PD-L1 positive head and neck squamous cell carcinoma.
The combination has been successful in the Phase I trial (NCT03538314), with an observed 67% overall survival rate at a three-year follow-up. While the company expects positive data in Q3 this year, it is prepared to wait for data readout from the DUVACC trial before deciding on the fate of UV1 should the FOCUS trial fail, said Ultimovac’s CEO Carlos de Sousa in a business update webcast today.
The Phase II DUVACC trial (NCT04742075) evaluates UV1 in combination with AstraZeneca’s checkpoint inhibitor Infinzi (duvalumab) and Lynparza (olaparib), a poly-ADP ribose polymerase (PARP) inhibitor, as a second line treatment in patients with BRCA negative ovarian cancer. The trial is currently recruiting patients, with 40% of the total expected enrolment completed as of Q4 2023.
UV1 is also being evaluated in an investigator-led Phase II LUNGVAC trial (NCT05344209). The study investigates the combination therapy of UV1 and Sanofi and Regeneron’s Libtayo (cemiplimab) as a first-line therapy in patients with advanced or metastatic non-small cell lung cancer. The trial started recruitment in October 2022 and reached only 15% enrolment as of Q4 2023. The topline data from the trial is expected in H1 2026.
GlobalData forecasts therapeutic cancer vaccines as the weakest immuno-oncology agent class with relatively low global sales of up to $4bn by 2028, compared to checkpoint modulators sales reaching $120bn by 2028.
GlobalData is the parent company of Clinical Trials Arena.
Other cancer vaccines in development include Transgene and Japanese NEC Corporation’s cancer vaccine, TG4050, for the treatment of head and neck cancers and ISA Pharmaceuticals’ cancer vaccine, ISA101b, for treating oropharyngeal cancer.
