OSLO, Norway--(BUSINESS WIRE)--Ultimovacs ASA ("Ultimovacs", ticker ULTI), today announced positive five-year Overall Survival (OS) data from the Phase I trial evaluating the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor, ipilimumab, in patients with metastatic malignant melanoma. After 5-years of follow-up, 50% of the patients in the open-label trial were still alive, providing encouraging signals of long-term survival benefit for UV1 in this late-stage patient population and as compared to historical data of ipilimumab monotherapy. As previously reported at ASCO-SITC in 2020, the trial achieved its primary endpoints of safety and tolerability. These results represent the third clinical trial with UV1 to provide positive data for 5-years of patient follow-up, further strengthening UV1’s profile as a safe and potentially effective addition to immuno-oncology treatment regimens.
“When we look at the trial results of ipilimumab monotherapy conducted in nearly identical clinical settings and patient population, we see in the literature a 5-year survival rate around 20%, median overall survival of around 16 months and median progression free survival of about 3.5 to 4 months,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Combining ipilimumab, which was the standard-of-care treatment at the time of the study initiation, with UV1, resulted in promising signs of improved survival with a safe and well-tolerated profile. At 5 years of follow-up, the median overall survival had not been reached and 50% of the patients were still alive, which are encouraging results in patients with metastatic melanoma.”
A total of 12 malignant melanoma patients with metastatic disease were treated in the Phase I trial. Eight patients of the 12 received UV1 combined with ipilimumab as first line treatment, and the remaining four patients received the combination after progression on previous systemic treatment. Immune responses toward the UV1 peptides occurred very early post administration, with 91% of the evaluable patients showing an immune response. In the efficacy-evaluable patient population, one patient achieved a complete tumor response and three patients achieved a partial response, resulting in an objective response rate of 44%. Primary endpoints for the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the data cut-off at the end of November 2020, every patient in the trial reached at least 60 months of follow-up post treatment with UV1 and ipilimumab. At the five-year mark, the OS rate was 50%, median OS had not yet been reached and median Progression Free Survival (mPFS) was 6.7 months. Over the course of the follow-up period, none of the patients experienced any unexpected safety issues related to UV1.
“In all four Phase I trials where UV1 has been tested, we have observed a consistent set of positive signals of clinical effect and a good safety profile for UV1. This strengthens our commitment to developing UV1 as a potential universal cancer vaccine that can be applied across multiple indications, in different combinations with other cancer treatments and in different stages of cancer,” stated Carlos de Sousa, Chief Executive Officer at Ultimovacs.“Our ongoing INITIUM Phase II clinical trial combines UV1 with ipilimumab and nivolumab in this patient population and today’s results reinforce the confidence we have in our approach of directing the immune system towards telomerase expressing cancer cells to improve clinical outcomes for patients in need of new treatment options.”
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes three randomized, multinational, Phase II combination trials recruiting more than 400 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.
Ultimovacs’ UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in a range of cancers and in several immunotherapy combinations while expanding our pipeline of cancer vaccine therapies, convinced that a universal approach may be the key to achieving better outcomes for patients.
For further information, please see www.ultimovacs.com.