Ultimovacs progresses on several fronts
The year’s third quarter saw Norwegian immuno-oncology developer Ultimovacs make several key advancements. Not only has the company progressed with its phase I clinical development of universal cancer vaccine UV1, but it has also announced the initiation of a fifth phase II trial with the candidate. To top things off, among other news, Ultimovacs was awarded dual Fast Track designation for UV1 from the FDA and raised 270 MNOK in a private placement.
Ultimovacs continues to progress steadily with the development of its cancer vaccine, UV1. This much was clear with the release of the company’s Q3 report, which indicates significant advancements for the Norwegian biotech company.
New phase II trial with UV1
One of the key highlights from Ultimovacs’ Q3 is the planned initiation of LUNGVAC, the company’s fifth phase II trial with UV1. LUNGVAC will evaluate the cancer vaccine in combination with checkpoint inhibitor (CPI) pembrolizumab (Keytruda) in non-small cell lung cancer (NSCLC) patients with advanced or metastatic disease. Lung cancer is one of the most common cancer indications globally and, according to WHO, the most common cause of cancer death in 2020. The primary endpoint of the trial will be progression-free survival, while the secondary endpoints will include response rate and overall survival. Read more about this initiative here.
With this announcement, Ultimovacs continues to demonstrate the strength of its clinical development pipeline, which is built around the company’s vision to combine UV1 with other classes of immunotherapy like CPIs to help give late-stage cancer patients extended survival times and remove or reduce the size of tumours.
Vision reinforced by phase I data
This vision was further reinforced when the company announced positive phase I data with UV1 in combination with pembrolizumab in advanced melanoma in early October. The combination showed the very encouraging survival rate of 80 per cent after 24 months. Read more here.
Validation from the FDA
A form of validation for Ultimovacs’ work also came in Q3 when the FDA granted UV1 dual Fast Track designation – one for the combination of UV1+pembrolizumab and one for the combination of UV1+ ipilimumab. This designation is aimed at facilitating frequent communication with the FDA, related guidance on clinical trial design, and can result in expedited review timelines to ensure that novel therapies are available sooner for patients with serious illnesses.
The decision helps pave the way for more regulatory benefits, not only for the projects in advanced melanoma, but also for Ultimovacs’ clinical development projects with UV1 in other cancer indications and in combination with other therapeutic classes. BioStock previously covered the story here.
Progress with TET platform
The UV1 projects were not the only ones progressing steadily during the quarter. Ultimovacs’ TET platform, a vaccine delivery platform based on patented technology that has the potential to generate multiple cancer vaccine candidates, also received an update. During the period, the company announced dosing the first patient in the second of three cohorts for the TENDU study (400 μg dose), with the main objective being to evaluate the safety of the vaccine in prostate cancer patients who have relapsed after radical prostatectomy.
Read more about the latest developments with TET here.
Stable financial footing and pleased CEO
With so many ongoing activities, and a new phase II trial to initiate, Ultimovacs is well placed financially. The Q3 report shows that the company’s cash equivalents amounted to 347.8 MNOK as of the end of September. However, that number does not include the additional 270 MNOK that Ultimovacs announced raising in a private placement in October.
Overall, the quarter was best summarised by Ultimovacs’ CEO Carlos de Sousa, who touches upon the fact that with the LUNGVAC study, the five phase II trials will enrol more than 650 patients at nearly 100 clinical centres across 15 countries – amounting to a significantly sized clinical pipeline for a company with under 30 full time employees:
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»We are pleased with the expansion of the UV1 clinical development program, which will now encompass five phase II trials with more than 650 patients, and the promising results observed in the Phase I trials of the universal cancer vaccine. Together with the development of our adaptable TET vaccine platform, Ultimovacs’ proprietary pipeline is strengthened, positioning the company as a collaborative innovator and leader in therapeutic cancer vaccines.«