Ultimovacs published its Q4 report last week, outlining the significant progress the company made in the final months of 2020 despite the ongoing Covid pandemic. BioStock has written more about this here.
During the live presentation of the Q4 report, the CEO mentioned Carlos de Sousa, CMOs Jens Bjørheim and CFO His Eid also some of the activities that the company has already carried out in 2021 and some that are pending, including an initial clinical trial to test the TET platform.
A new cancer vaccine platform
In addition to the universal vaccine UV1 is developing Ultimovac's new vaccine products based on the patented technology called Tetanus-Epitope Targeting (TET). The TET platform is a delivery system based on an adjuvant to which vaccine peptides can be added to promote an immune response. It offers a promising approach to strengthen and increase T-cell responses against cancer-specific peptides by combining antigens and vaccine adjuvant in the same molecule, enabling a favorable safety profile and simplified drug administration.
As demonstrated in the preclinical development stages, the platform has the potential to generate new, first in class cancer vaccine candidates that exploit the pre-existing antibody response to tetanus derived from the standard tetanus vaccination. These vaccine candidates can be tailored for many different types of cancer, and the platform also opens up the potential to generate vaccine candidates aimed at treating infectious diseases.
The TENDU study will test TET
Shortly after presenting its Q4 report, Ultimovacs announced that it had initiated the TENDU clinical trial – a first-in-human Phase I study testing the TET platform. The study is being conducted at Oslo University Hospital and evaluates the safety of the vaccine in patients whose prostate cancer has recurred after radical prostatectomy. A total of 9–12 patients are expected to participate in the study.
Dr Wolfgang Lilleby, principal investigator at Oslo University Hospital, is very motivated to lead the study:
"By offering Ultimovacs' new therapeutic prostate cancer vaccine to patients who have relapsed after radical prostatectomy but prior to their standard radiation and antihormone therapy, we hope to further reduce the risk of recurrence and to take the next step towards a better outcome for these patients.The design of the study allows us to obtain a range of important insights regarding the activation of the immune system, including following the patients to identify novel biomarkers. I am convinced that the TET technology has great potential to aid us in our battle against prostate cancer and it is a great pleasure to participate in this trial.”
The primary objective of the study is to evaluate the safety and tolerability of three different doses of the vaccine. Patients will receive the vaccine before receiving standard treatment consisting of radiation and anti-hormonal therapy. They will then be followed for 6 months after the last dose of the vaccine to assess immunological responses such as T-cell activation and anti-tumor activity. Patient enrollment is expected to be completed in the first half of 2022.
Sara Mangsbo, Chief Innovation Officer at Ultimovacs, talked about the importance of this study in a recent press release:
"Conducting the TENDU study is an important step for us to gain initial data on the novel platform, while continuing to optimize the core TET molecule and production process. The TET technology will enable us to expand our pipeline and bring us closer to fulfilling our ultimate ambition of establishing Ultimovacs as a leader in the cancer vaccine field."
Active clinical development
The TENDU study expands Ultimovac's already extensive clinical development pipeline, which includes four Phase I studies and four Phase II studies with the UV1 vaccine. The company's fourth quarter report also states that it expects negative cash flow to increase in 2021, primarily due to an increase in R&D costs. The increased costs are due to the initiation of the TENDU study, the continued inclusion of patients in the INITIUM and NIPU studies, and the initiation of the new Phase II studies DOVACC and FOCUS.
However, thanks to a strong cash position, the existing financing is expected to take the company through the results of primary endpoints in the Phase II studies in 2022 and 2023. For a more comprehensive account of Ultimovac's clinical pipeline, read here and here.
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