Ultimovacs - Explanation of why a universal cancer vaccine is better than personalized vaccines from Moderna and BioNTech/Pfizer.

I am invested in Ultimovacs and I am writing to share my reasons for this investment. I have a strong interest in the company's approach and have simplified some of the technical details to convey my rationale in a clear and concise manner.

The development and progression of primary tumors involves a complex interplay between the cancer cells and their microenvironment, which includes elements such as blood vessels, extracellular matrix and connective tissue, as well as immune cells. This phenomenon is often referred to as the "seed and soil" hypothesis, as it compares the growth and survival of cancer cells to that of a seed's dependence on its soil and nourishment.

The primary tumor is characterized by the uncontrolled growth of cancer cells, which is caused by various genetic and environmental factors such as exposure to carcinogens. This is a defining feature of tumor cells, as they have undergone mutations that disrupt the normal cellular mechanisms that regulate growth and cell death. These mutations often accumulate over time, and as a result, the risk of cancer increases with age. It is important to note that multiple mutations are typically required for the development of a primary tumor, and that the body's normal mechanisms for correcting errors and mutations are often overwhelmed over the course of a lifetime.

The uncontrolled growth of cancer cells can, to a large extent, be detected and eliminated by the body's immune system. However, problems arise when cancer cells also become inflamed. Inflammation not only helps cancer cells survive but also evades immune surveillance. It is through the actions of immune cells and surrounding connective tissue cells that inflammation is created by secreting specific cytokines and chemokines. As the cancer grows and spreads, the protumor microenvironment (consisting of cells such as M2 macrophages, cancer fibroblasts, Treg cells, MDSC cells, etc.) gains an advantage over the antitumor components of the microenvironment (such as M1 macrophages, CD8+ cells, CD4+ cells, NK cells, etc.).

For decades, cancer research has primarily centered on identifying and comprehending the genetic mutations present in primary tumors, with the aim of developing methods to correct them. However, in recent years, the significance of the tumor microenvironment in cancer development and progression has gained increasing recognition. As a result, research efforts have shifted towards understanding the role of the microenvironment in tumor growth. It is widely acknowledged that both the primary tumor and the microenvironment play vital roles in cancer development and that successful treatments for advanced cancer will likely necessitate modulation of both.

In the realm of biotechnology, recent advancements in the understanding of immuno-oncology have led to the development of "immune checkpoint inhibitors," a class of biological drugs that enhance the ability of the immune system to target and eliminate cancer cells. These drugs target specific checkpoints and have demonstrated promising efficacy, particularly when used in combination with other immuno-oncology drugs or conventional cancer therapies, and in non-solid tumor types.

However, there remains a significant need for new and effective cancer therapies. In particular, researchers are exploring the potential of drugs that enhance the immune system's ability to fight cancer, such as cancer vaccines. These vaccines come in various forms and are under development. Some focus on "neoantigens," which are unique markers found only on the surface of cancer cells, allowing the immune system to identify and target them. By identifying tumor-specific neoantigens from a patient's tumor, a personalized vaccine can be created to train the immune system to target and eliminate the cancer cells bearing those neoantigens. This vaccine technology is currently in clinical trials, with companies such as Moderna and BioNTech/Pfizer at the forefront of development.

In contrast to neoantigens, which are unique to individual cancer cells, there are also antigens that are present in a majority of cancer cells. Telomerase, for example, is a marker that is commonly found in many types of cancer. Ultimovacs is developing a vaccine that targets this marker in order to train the immune system to recognize and eliminate cancer cells. This approach is particularly promising when used in combination with modern checkpoint inhibitors.

It remains to be determined whether neoantigen vaccines will be effective in the long-term, as the adaptability of cancer cells may lead to the emergence of other neoantigens following treatment. However, the approach being taken by Ultimovacs in targeting telomerase, a marker commonly found in many types of cancer, may provide a unique opportunity for success, particularly when combined with modern checkpoint inhibitors. The company has also demonstrated promising results in early stage clinical trials.

Investing in biotech, particularly in the field of cancer therapeutics, carries a high level of risk and is often binary in nature. It is important for individuals to consider their own financial circumstances and only invest what they can afford to lose. The development of drugs against cancer has historically had a low probability of success, and many promising candidates have failed in clinical trials. However, if Ultimovacs' UV1 vaccine proves to be effective, it has the potential to be a significant breakthrough in the field, which may justify the associated risk. Additionally, the company is expected to release data soon that may provide further clarity on the drug's potential.

This post may have simplified certain aspects of the topic for some experts, while others may have found it to be too detailed. Regardless, the potential of Ultimovacs' UV1 vaccine, particularly in combination with modern checkpoint inhibitors, and the data that will be released soon, have led me to become a shareholder in the company. I have made an initial investment and plan to consider increasing my stake if the Phase II data is positive.

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 has been borrowed from Roc on Tekinvestor.

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.