OSLO, Norway–(BUSINESS WIRE)–Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced its participation in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to conduct a randomized Phase II clinical trial to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer.
“The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer. We look forward to working with Ultimovacs to reach our mutual goal.”
Carlos de Sousa, Chief Executive Officer at Ultimovacs stated: “Now that the formal collaboration with NSGO-CTU/ENGOT and AstraZeneca is in place and preparations for the study are well underway, I am happy to provide further details on the DOVACC Phase II clinical trial, which was first announced in May of 2020. A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options. Ultimovacs has four Phase II trials evaluating UV1, including more than 500 patients in total, supporting its universal potential across many cancer indications and as part of various treatment combinations.”
“The NSGO-CTU is a highly regarded oncology society that has strong connections with similar organizations across Europe through the ENGOT collaboration,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe.”
“Our purpose at the NSGO-CTU and ENGOT is to improve treatment options in gynaecological cancer indications by coordinating clinical trial efforts across countries,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT. “The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer. We look forward to working with Ultimovacs to reach our mutual goal.”
DOVACC is a multi-center, multinational, randomized Phase II clinical trial 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 BRCA-mutated advanced ovarian cancer. The trial will be conducted at more than 30 hospitals in around 10 European countries. The Company expects to treat the first patient in the first half of 2021. Topline data on the primary endpoint is expected in 2023.
The second-line maintenance study will enroll patients with high-grade BRCA negative ovarian cancer after partial or complete response following the second round of chemotherapy. The study includes three arms treating a total of 184 patients. The first arm will enroll 46 patients receiving the PARP inhibitor olaparib. The 46 patients enrolled in the second arm will receive olaparib and the checkpoint inhibitor durvalumab. The third arm will include 92 patients that will receive Ultimovacs’ UV1 vaccine in combination with both AstraZeneca drugs. The primary endpoint is progression-free survival (PFS) in the treatment arm with solely the PARP inhibitor olaparib, versus PFS in the triple combination treatment arm. Under the terms of the collaboration, Ultimovacs will provide its UV1 vaccine and AstraZeneca will provide the PD-L1 and PARP inhibitors for the study.
Innovation Norway has granted Ultimovacs NOK 10 million, approximately EUR 1 million, to support the execution of the Phase II DOVACC study. In addition, the successful private placement in May of this year raised NOK 160 million, approximately EUR 16 million, allowing Ultimovacs to continue to implement the Company’s clinical development plan and fund its operations through the expected readout of the primary endpoint in the DOVACC study in 2023.
Ultimovacs management will host a webcast on Monday, January 11, 2021, at 11:00 a.m. CET to discuss the DOVACC clinical trial in more detail. The webcast will also feature a short video statement from lead investigator Dr. Mirza. The live webcast can be accessed through the investor section of Ultimovacs’ corporate website at www.ultimovacs.com. The webcast replay will be available for at least 72 hours following the call.
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. 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 Gynaecological 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. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022 and for the DOVACC and FOCUS studies in 2023.
About the 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 the ENGOT
ENGOT is a platform that guarantees that the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that all European patients and countries can participate in an active way in clinical research and progress. The 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.
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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