Ultimovacs Announces Positive Topline Results from Phase I Combination Trial Evaluating Universal Cancer Vaccine, UV1, in Malignant Melanoma Patients

Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today announced positive topline results from the first cohort of 20 patients in its ongoing US-based Phase I clinical trial evaluating the Company’s lead candidate, UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab, as a first line treatment in patients with metastatic malignant melanoma. The results confirm achievement of the primary endpoints of safety and tolerability and indicate initial signs of clinical response.

As per the cut-off date of September 30, 2020, every patient in the first cohort reached at least 12-months of follow-up post treatment with UV1 and pembrolizumab. At the one-year landmark, the overall survival (OS) rate was 85%. Median Progression-Free Survival (mPFS) was not reached at 12 months, indicating that more than half of the participating patients did not demonstrate disease progression. None of the patients experienced unexpected safety issues related to UV1 and the vaccine was well-tolerated. The safety events observed are in line with the established data on UV1 and pembrolizumab.

"The safety profile observed to date in this first cohort of the PD-L1 combination study is consistent with the promising safety profiles seen in our earlier Phase I trials. For the further development of our vaccine, it is important to demonstrate that UV1 can be combined with different classes of immunotherapies without compromising on safety,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs. "From our perspective, an appropriate historical comparison for our trial is the cohort in the KEYNOTE006 trial in which patients with advanced melanoma without prior treatment history were treated with pembrolizumab only. Results from that study demonstrated a 68% OS and a mPFS of 11.6 months. Comparing this to our data presented today, we are encouraged by the results and look forward to additional data readouts over the next years that will demonstrate if the initial signs of efficacy in this cohort persist and mature into long-term added clinical benefit for the patients.”

The Phase I trial in malignant melanoma is evaluating the safety, tolerability and initial signs of clinical response in patients treated with UV1 in combination with pembrolizumab. Pembrolizumab improves the ability of immune cells to kill tumor cells and is a current standard-of-care therapy for malignant melanoma. The 20 patients in the first cohort had no prior treatment history and received a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination, combined to strengthen the ability of UV1 to stimulate the immune system. The study has completed full enrollment of 30 patients, as announced on August 18, 2020. The 10 patients in the second cohort have received the standard 75 µg GM-CSF adjuvant dose per UV1 vaccination. One-year of follow-up data on these patients will be available in the second half of 2021.

"In all four Phase I studies, UV1 has demonstrated a consistent and positive safety and tolerability profile. The topline results announced today complement our extensive and growing clinical data package, confirming that this strong safety profile holds when combining UV1 with a PD-1 checkpoint inhibitor,” stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "As an update on other clinical development progress, we had announced in May this year a collaboration with a leading Big Pharma company and a European oncology clinical trial group to evaluate UV1 in an additional Phase II study, which we had planned to confirm with all details in the third quarter. Ultimovacs, the sponsor and the Big Pharma partner have been making improvements to the trial protocol and due to the challenges of operating in the current pandemic environment, the agreement is still in the process of finalization. We look forward to announcing the collaboration and trial timelines during the fourth quarter.”

More complete data on the patients in the first cohort will be presented at an upcoming oncology conference in the first half of 2021.

About UV1 and the UV1 Phase II Clinical Trials

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 immuno-oncology drugs which require 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.

UV1 is being tested in different randomized Phase II trials:

• The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be treated with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S. and Europe, including Norway. The first patient was dosed on June 15, 2020. A total of 154 patients will be enrolled in the study, 77 patients will receive nivolumab and ipilimumab and the second half of the patients will receive nivolumab, ipilimumab and UV1. The primary endpoint for the study is progression-free survival and the planned readout of the primary endpoint is in the second half of 2022.
• The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. The first patient was dosed on June 15, 2020. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned readout of the primary endpoint progression-free survival is the second half of 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 (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the 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.

About Ultimovacs

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

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