Ultimovacs ASA (ULTMF)

[U4]

Universal cancer vaccine with very promising effect! (Multi-bagger potential)

Imagine a world where cancer treatment is revolutionized by a single breakthrough discovery - a universal cancer vaccine with incredibly promising results. This revolutionary new vaccine has the potential to improve outcomes in all immunotherapies and offer long-lasting effects without the need for screening. Not only that, but it also boasts a good safety profile, is ready to use off the shelf, and easy to administer.

Are you ready to dive into the details of this groundbreaking discovery? Keep reading to find out more.

The potential for a new and innovative cancer treatment could be just around the corner, as Ultimovacs conducts a revolutionary clinical trial, INITIUM, across the United States and Europe. This Phase II randomized trial is evaluating the use of a cancer vaccine called UV1 in combination with checkpoint inhibitors (CPIs) ipilimumab and nivolumab for the treatment of first-line metastatic malignant melanoma. The trial design is event-driven, meaning that the primary endpoint will be reached when a certain number of events, such as disease progression or death, have occurred. Specifically, the trial will reach its endpoint when 70 progression-free survival (PFS) events have been recorded.

With 156 patients already enrolled in the INITIUM trial, who are randomly assigned to receive either the combination treatment or CPIs alone, Ultimovacs has been providing regular updates on the enrolment status to investors. Though the company has not explicitly stated the hypothesis being tested, it is believed to be a hazard ratio (HR) of 0.60, which would correspond to 41 events in the control arm and 29 in the experimental arm.

There are two large historical trials in malignant melanoma that can be used as controls for INITIUM: Checkmate-067 and Checkmate-511. Both of these trials had the same inclusion and exclusion criteria as INITIUM, so it is reasonable to expect similar PFS event rates in the control arm of INITIUM. Using the recruitment curve and the PFS curves from Checkmate-067 and Checkmate-511, it is possible to estimate the number of events that are likely to have occurred in the control arm of INITIUM. If the control arm in INITIUM progresses at the same rate as in Checkmate-067, the primary endpoint will be reached at the end of this month. If the INITIUM study can be more accurately compared to the Checkmate-511 study, the results may even meet the requirements for accelerated approval within a few weeks.



Here is an overview that illustrates the progress compared to CM-067. The chart shows that assuming there are 70 events today, there is a higher likelihood of achieving a significant outcome (i.e. a minimum of 41 events).




The next graph illustrates the development compared to CM-511 and CM-067. The chart shows that the estimated chances of achieving a significant outcome using CM-511 and CM-067 as a reference, assuming today's readings, range between 77% and 53%, and the probability that UV1 has no effect is between 2%-8%.




Overall, the combination of an event-driven design, detailed enrolment information, and large and valid historical controls creates unique opportunities for investors in Ultimovacs and its clinical trial INITIUM. The cancer vaccine UV1 has the potential to be effective in a wide range of cancers due to its targeting of cells expressing the enzyme telomerase, which is necessary for the survival and growth of 85-90% of cancers. If the results of the trial are positive, it could be a significant advancement in the treatment of malignant melanoma and other types of cancer.

A significant opportunity exists here that the market has yet to realize.

Ultimovacs, the Norwegian biotechnology company developing the universal cancer vaccine UV1, is publicly listed on the Oslo Stock Exchange in Norway under the ticker symbol ULTI.

If you have any questions about Ultimovacs or UV1, feel free to ask them, and I will try to answer them to the best of my ability.

P.S.: Much of the aforementioned text is borrowed from Bio_Polygon and the graphs are borrowed from Ketilaaj.