Ultimovacs will participate 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.
The collaborators will conduct a randomized Phase II clinical trial to evaluate Ultimovacs’ universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer.
“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,” says Carlos de Sousa, Chief Executive Officer at Ultimovacs.
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’ 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.
NOK 10 million from Innovation Norway
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, it states.