Q2 was all about increasing momentum in the clinic for Norwegian Ultimovacs. The company’s universal cancer vaccine UV1 has progressed steadily in one of its phase I trials and in its four phase II trials. CEO Carlos de Sousa joined BioStock for a comment on the newly released report.
One of the first highlights from Ultimovacs’s Q2 report is the release of data from their phase I trial with UV1 and checkpoint inhibitor CPI pembrolizumab in advanced malignant melanoma patient. This suggests that the combination increases survival times and reduces tumour size or makes tumours disappear. The full results were presented at the ASCO conference in June and are a testament to the combination potential that UV1 has not only in melanoma, but in other cancers as well.
BioStock reported on those results here, including an in-depth Q&A with the trial’s lead investigator Yousef Zakharia, MD.
This month, the company announced further positive data from the trial, reinforcing the results presented at ASCO. Again, the data, which came from the second cohort of 10 patients, showed strong safety and efficacy data after one year (60 per cent objective response, 30 per cent complete response, 90 per cent overall survival and median progression-free survival not yet reached).
Phase II trials in the spotlight
Ultimovacs also progressed strongly with its phase II programmes during Q2 and since the end of the period. UV1 is being investigated in four phase II trials: INITIUM, NIPU, FOCUS, and DOVACC. The programmes cover over 500 patients in total, and tests UV1 in combination with various checkpoint inhibitors (CPIs). All four trials are randomised, with a proportion of the patients given the standard therapy and the remainder given standard therapy plus UV1.
Currently both the INITIUM and NIPU trials are the triple combination of UV1 and the CPIs ipilimumab (Yervoy) and nivolumab (Opdivo) in metastatic malignant melanoma and in mesothelioma, respectively. Both studies have been enrolling patients since June 2020, and the NIPU study, which saw its first patient dosed on 15 June 2020, is sponsored by the Oslo University Hospital and has Bristol Myers Squibb (BMS) as a collaborator. Now, 38 patients have been recruited for NIPU.
»A clear picture is emerging that shows UV1 is an excellent combination partner in tumours where checkpoint inhibitors are the standard of care, and that is of course supported by the clinical data.« — Carlos de Sousa, CEO Ultimovacs
Meanwhile, in April, Ultimovacs was at yet another major oncology conference, AACR. There, the company shared details of the INITIUM study design. Read more about this here. 68 patients are enrolled to date compared to 40 patients in the previous quarterly report.
Earlier this month, Ultimovacs announced that the first patient had been enrolled in the company’s FOCUS trial, an investigator-led randomised phase II trial testing UV1 in combination with the pembrolizumab in head-and-neck cancer patients. The trial is run at 10 sites across Germany, and the primary endpoint is progression-free survival rate at six months, with readout of topline results expected in 2023.
New technology platform in the works
Last, but certainly not least during Q2, Ultimovacs took a step in broadening its pipeline with a second technology platform, the Tetanus-Epitope-Targeting (TET) platform, progressing through a dose-escalating phase I study (TENDU) in prostate cancer patients. The TET platform allows the inclusion of a broad range of peptides and antigens, giving the company the ability to design vaccine candidates that can target different cancer indications at different stages for specific populations.
BioStock reached out to CEO Carlos de Sousa to get his take on the progress made during Q2 and what the company’s priorities are, looking ahead.
Carlos de Sousa, the Q2 report for Ultimovacs shows strong progress for the company with its clinical programmes. What are you most satisfied with from this period?
– We’ve made particularly strong clinical progress this quarter with encouraging results from the phase I trial of our lead asset UV1 combined with pembrolizumab in malignant melanoma. The data confirm UV1’s potential to improve the performance of checkpoint inhibitors and positively impact survival for patients, while the good safety profile supports the use of UV1 in combination with checkpoint inhibitors in other cancers. UV1 is now being investigated in three phase II trials in combination with various checkpoint inhibitors, with enrolment about to start in a fourth, covering over 500 patients in total. All four trials are randomized, with a proportion of the patients given the standard therapy and the remainder given standard therapy plus UV1. This provides a very solid foundation to assess the effectiveness and safety of UV1 in multiple indications and different combinations.
This quarter, Ultimovacs has attended two virtual conferences to share its data. How important is it for Ultimovacs to raise awareness about its cancer vaccine, and would you say there is now a clinical picture of UV1 taking shape?
– It’s vital for us to raise awareness for our cancer vaccine. Our presentations at AACR and ASCO sparked interest in our vaccine from both the scientific community and investors. Also in the quarter, peer reviewed publications on our phase II trial designs and on our target antigen have strengthened its scientific validation. A clear picture is emerging that shows UV1 is an excellent combination partner in tumours where checkpoint inhibitors are the standard of care, and that is of course supported by the clinical data.
Finally, looking ahead, what are the main priorities for Ultimovacs as the company advances with its phase II programmes?
– We are building momentum in recruitment for our phase II trials, with new sites opened for the INITIUM and NIPU trials in melanoma and mesothelioma, respectively, and having just enrolled our first patient in the FOCUS trial in head and neck cancer. The DOVACC trial in ovarian cancer has now received regulatory approval and we expect to enrol the first patient shortly. We are also looking to progress our second technology, the TET platform, through the dose-escalation phase so we can generate the safety and immune activation data needed for further development. So, there are a number of important clinical milestones ahead for Ultimovacs as we continue to focus on bringing novel and improved treatment options to cancer patients.
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