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First Patient Enrolled in Phase II DOVACC trial of UV1 in Advanced Ovarian Cancer

Oslo, 15 December 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced today that the first patient has been enrolled in the DOVACC (Durvalumab Olaparib VACCine) study, a randomized Phase II clinical trial assessing the impact of the Company’s telomerase vaccine, UV1, on the standard of maintenance care in ovarian cancer.

DOVACC (NCT04742075) is organized with two influential European networks of gynaecological oncologists; the Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU) - the study sponsor - and the broader European Network of Gynaecological Oncological Trial Groups (ENGOT). With Ultimovacs and AstraZeneca as industry participants, DOVACC will assess whether UV1 enhances progression-free survival in BRCA-negative (BRCA wild type) advanced ovarian cancer in combination with two AstraZeneca drugs, durvalumab and olaparib. Topline data from DOVACC is expected in 2023.

PARP inhibitors such as olaparib are highly effective as maintenance care in BRCA-mutated ovarian cancer. However, among BRCA-negative patients – who represent the majority of ovarian cancer patients – there remains a specific unmet medical need that may be satisfied by the addition of other agents to PARP monotherapy.

DOVACC will recruit 184 patients across Europe from a network of more than 40 hospitals in around ten European countries coordinated through NSGO-CTU and ENGOT. Innovation Norway has granted Ultimovacs NOK 10 million (approximately $1.2 million) to support the execution of the Phase II DOVACC study.

“The start of recruitment in DOVACC represents another milestone in the expanding clinical program of our lead cancer vaccine UV1,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Working with leading specialized groups around Europe who participate in NSGO-CTU and ENGOT, puts UV1 in the hands of the oncologists who help shape the standard of care in ovarian cancer.”

DOVACC is one of five randomized Phase II clinical trials of Ultimovacs' telomerase vaccine UV1 in combination with other immunotherapies. The primary outcome measure for DOVACC is progression-free survival for the UV1-durvalumab-olaparib triple combination versus olaparib alone.

"The purpose of both NSGO-CTU and ENGOT is to improve treatment options in gynaecological cancer indications by developing and conducting clinical trials with novel agents and novel modalities, bringing these new options to the European community," commented Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of ENGOT. "The DOVACC study does exactly that by bringing together clinical and commercial organizations in pursuit of a shared goal, in this case extending the effectiveness of maintenance care for ovarian cancer."

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About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. It is being developed as an “off-the-shelf” therapeutic cancer vaccine for use in combination with other immunotherapies that require an ongoing T cell response for their mode of action. In four Phase I trials involving 82 patients, UV1 has maintained a positive safety and tolerability profile and has demonstrated encouraging signals of efficacy. UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer (NSCLC). In total, the five Phase II trials will enroll more than 650 patients at nearly 100 clinical centers across 15 countries.

In 2021, the U.S. FDA granted Fast Track designation to UV1 as add-on therapy to ipilimumab or to pembrolizumab for the treatment of unresectable or metastatic melanoma, as well as Orphan Drug designation to UV1 for the treatment of stage IIB – IV melanoma.

About DOVACC
DOVACC (Durvalumab Olaparib VACCine; also formally designated as ENGOT-OV56/NSGO-CTU-DOVACC) is a multi-center, multinational, randomized Phase II clinical collaboration trial with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca. The trial is sponsored by the NSGO, the leading gynaecological oncology research society in the Nordic and Baltic regions. The trial is designed to evaluate Ultimovacs’ proprietary UV1 cancer vaccine in combination with AstraZeneca’s durvalumab, a PD-L1 checkpoint inhibitor and its PARP inhibitor, olaparib, the maintenance therapy for advanced ovarian cancer. The study includes three arms treating a total of 184 patients randomized 1-to-1-to-2 to receive the PARP inhibitor olaparib, olaparib and the checkpoint inhibitor durvalumab, or Ultimovacs’ UV1 vaccine in combination with both AstraZeneca drugs. The primary endpoint is progression-free survival (PFS) in the treatment arm with PARP inhibitor olaparib monotherapy, versus PFS in the triple combination treatment arm.

About NSGO-CTU
The Nordic Society of Gynaecological Oncology - Clinical Trial Unit (NSGO-CTU) is a non-profit organization aiming to improve the practice of prevention, diagnosis and treatment for gynaecological cancers by supporting research and conducting clinical trials across countries.

About ENGOT
The European Network for Gynaecological Oncological Trial groups is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Currently, ENGOT consists of 19 trial groups from 15 European countries that perform cooperative clinical trials. ENGOT's ultimate goal is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.

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 85-90% 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 technology approach, 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, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, CFO
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 considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on December 15, 2021 at 08:00 CET.