Ultimovacs’ Announces Review Article Highlighting Telomerase-based Therapeutic Cancer Vaccines

Oslo, 5 July 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today announced the publication of a review of telomerase-based therapeutic cancer vaccines including the Company’s universal cancer vaccine, UV1. The article in Frontiers in Immunology examines the broad relevance of telomerase as an attractive cancer target and examines opportunities for optimizing anti-telomerase vaccine performance both by selecting appropriate cancer types and by analyzing the underlying limitations of current standard treatments.

The article focusses on the synergy between telomerase-based cancer vaccines and checkpoint inhibitors. In particular, it highlights areas within cancer treatment where clinical trials have shown that specific combinations of the two components are more effective than either component used alone. Checkpoint inhibitors, of which there are several varieties, have become the standard treatment for many solid tumor types. There is a strong rationale for combining them with telomerase vaccines to boost the activity of cells involved in the anti-cancer immune response.

"This latest article articulates the rationale for using telomerase-targeting cancer vaccines as a key to unlock the full potential of checkpoint inhibitors.” stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "For our universal cancer vaccine, UV1, the early read-outs from our combination trial with pembrolizumab indicate that this rationale is playing out well in the clinic.”

Ultimovacs recently released data from the first cohort of a Phase I trial where UV1 in combination with pembrolizumab showed a 60% objective response rate (including 30% complete responses) in advanced malignant melanoma, an evident improvement over pembrolizumab alone*. UV1 is currently in clinical development with four randomized, multinational, Phase II combination trials which will recruit over 500 patients in advanced malignant melanoma, ovarian cancer, head-and-neck cancer and malignant pleural mesothelioma.

As the review in Frontiers in Immunology points out, telomerase is an attractive target because it is broadly expressed on 85-90% of all tumor types, especially in metastatic cancer cells. Furthermore, it plays an essential role in cancer cell reproduction, making it difficult for tumor cells to mutate and evade the treatment. Combining telomerase cancer vaccines with checkpoint inhibitors appears to improve overall treatment responses and outcomes by helping to prevent tumors hiding from or disabling patients’ immune defenses.

The Frontiers in Immunology review also suggests that, although most of the current clinical trials evaluate treatments of late-stage disease in heavily pre-treated patients, there is potential for telomerase-targeting therapeutic cancer vaccines in earlier disease settings, when the need to combine them with other treatments might be reduced.

The publication in Frontiers in Immunology can be found under doi: 10.3389/fimmu.2021.682492.
"Telomerase as a target for therapeutic cancer vaccines and considerations for optimizing their clinical potential”

*Sources: FDA pembrolizumab packet insert; EMA pembrolizumab product information; Robert, C. et al (2019) Lancet Oncology 20, 1239-1251

About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf” 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 four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.

• 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.
• The DOVACC study is sponsored by the Nordic Society of Gynecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca.
• FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen.

About Ultimovacs
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in over 80% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. With a broad Phase II program, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. Ultimovacs’ second vaccine design, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, Chief Executive Officer
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, Chief Financial Officer
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act