Ultimovacs is a Norwegian immuno-oncology company that develops UV1, a cancer vaccine that aims to strengthen the patient's immune system to fight a wide range of cancers. The company's strategy is to combine its vaccine with immunotherapies called checkpoint inhibitors (CPIs). The intention is to create a strong immune response against the tumor while eliminating the tumor's ability to suppress this response.
To achieve this goal, Ultimovacs has established a broad clinical pipeline evaluating UV1 in a number of cancer indications with substandard treatment outcomes. Five studies are in clinical phase II, where Ultimovacs expects to enroll more than 650 patients at nearly 100 clinical centers in 15 countries, including the US.
Ultimovac's clinical program, which has expanded over the past two years, has seen UV1 tested in combination with four of the five top-selling CPIs approved by regulatory authorities. According to a recent analysis from Global Data Checkpoint modulation is the most valuable sector in immuno-oncology, with a market value expected to reach $67 billion by 2026 (16 percent compound annual growth rate from 2019). Merck Keytruda (pembrolizumab) – an anti-PD-1 CPI – leads this market and is used in combination with UV1 in two of Ultimovac's phase II studies.
Patent protection for combination treatments
As Ultimovacs continues to advance clinically, the prospects for commercialization increase – and the company is therefore taking steps to protect its proprietary technology. Last week, the company announced that it has received a so-called Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) regarding a patent protecting the use of the technology to treat cancer. Once formally granted, the patent will be valid until at least June 2037. Ultimovacs has similar patent applications pending approval in other regions around the world, including Europe, Japan, Canada and Australia.
The scope of the patent is quite broad and will encompass cancer treatments that include the UV1 peptide vaccine in combination with three different CDIs (anti-CTLA-4, anti-PD-1 or anti-PD-L1).
Ultimovac CEO Carlos de Sousa commented on the news:
»We are pleased that Ultimovacs' innovative contributions to combination immunotherapies in cancer have been validated by the USPTO. The company's universal cancer vaccine UV1 is being assessed in combination with checkpoint inhibitors in five phase II trials for various cancers. The allowed claims will cover such combination treatments across these and other cancer indications and will extend proprietary use of the vaccine in combination with these checkpoint inhibitors until at least 2037.«
Increased commercial potential
For pharmaceutical and biotechnology companies, stronger intellectual property rights mean better protection of the technology (methods, substances, formulations, etc.) used in the development of their pharmaceutical products, and thus a stronger position in the market once their products have been approved by regulatory authorities. Ultimovac's expanded patent portfolio for UV1, of which four patent applications are either pending or have already been recognized by the authorities, is thus a significant long-term value driver for the company.
Overall – once this patent is granted, it will support the company's positioning for future commercialization, and it will provide Ultimovac with increased opportunities to increase the commercial value of the company and its drug candidates going forward.