Ultimovacs progresses to last cohort in TENDU study
Ultimovacs continues to progress with its phase I TENDU study testing the company’s TET cancer vaccine platform in prostate cancer patients. The company has announced moving on to its last of three patient cohorts after no safety concerns were found in the first two.
Ultimovacs is a Norwegian immuno-oncology biotech developing UV1, a cancer vaccine aimed at boosting a patient’s immune system to fight off a wide range of cancerous diseases. The company has put together a broad clinical pipeline to evaluate UV1 in a number of indications where standard-of-care is poorly effective.
New vaccine platform development
In addition to the universal vaccine, UV1, Ultimovacs is developing novel vaccine products based on the patent-protected technology called Tetanus-Epitope Targeting (TET). The TET platform is a vaccine delivery system based on the addition of adjuvant to vaccine peptides. The adjuvant activates the immune system so that a relevant immune response can happen. The antigen directs the quality of the immune response. Together, they ensure a specific and effective immune response, and this approach allows for a beneficial safety profile and simplifying administration. Read more about this new technology here.
In early 2021, Ultimovacs entered the next step in its vaccine platform development by dosing the first patient in its TENDU study, a phase I trial investigating a prostate cancer-specific therapeutic TET-based vaccine in patients who have relapsed following radical prostatectomy. The trial is conducted at Oslo University Hospital, and 9 patients are expected to be enrolled.
Phase I study progresses
The primary objective of the study is to evaluate the safety and tolerability of three different doses of the vaccine. Last week, the company announced completing treatment of the second dose cohort and moving on to the third and final cohort after being notified by the Drug Safety Monitoring Board (DSMB), a group of experts set up to monitor patient safety during a clinical trial, that no safety concerns had been found related to the first two dose cohorts.
Six patients overall have been treated, three in each dose level (40 mcg and 400 mcg). The last cohort of patients will receive a 960 mcg dose.
Ultimovacs’ Chief Medical Officer Jens Bjørheim commented on the news:
»The continued progress of the phase I safety evaluation of the TET platform is very encouraging. Our main focus at this stage in the TENDU study is the safety and tolerability of our new therapeutic vaccine candidate for prostate cancer, a cancer type where the unmet medical need is high. This result also feeds into Ultimovacs’ plans for the development of the TET platform more broadly as an extension of the company’s pipeline.«
Patients in the TENDU study will receive the vaccine prior to obtaining standard-of-care treatment consisting of radiation and antihormone therapy. They will then be followed for six months after the last dose of the vaccine to assess immunological responses such as the activation of T-cells.
Ultimovacs’ TENDU study is part of the company’s already vast clinical development portfolio, which includes four phase I trials and five phase II trials with their UV1 vaccine. Read more about the recent progress with those here.
If TENDU continues to bring positive results, there is strong potential for evaluating the TET platform for other vaccine candidates and other cancer indications, thus extending the company’s broad pipeline even further. This is because, according to the company, TET allows for the inclusion of a broad range of peptides and antigens, giving Ultimovacs the ability to design vaccine candidates that can target different cancer indications at different stages for specific populations.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.