Ultimovacs has announced that the first patient has been enrolled in a phase II trial designed to assess the impact of the company’s universal cancer vaccine on the standard of maintenance care in ovarian cancer. The primary outcome measure is progression-free survival for UV1 in combination with AstraZeneca’s durvalumab+olaparib versus olaparib alone.
In early 2021, Ultimovacs announced participating in a collaborative effort to evaluate the company’s universal cancer vaccine UV1 in advanced ovarian cancer. The Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU) and the European Network of Gynaecological Oncological Trial Groups (ENGOT) organised the DOVACC phase II trial for this effort, with the former sponsoring the trial. AstraZeneca is also a collaborator, joining Ultimovacs in supplying the drugs for the trial. Read more about the trial here.
The randomised clinical trial is designed to evaluate UV1 in combination with AstraZeneca’s durvalumab (Imfinzi), a PD-L1 checkpoint inhibitor, and its PARP inhibitor, olaparib (Lynparza), in high-grade BRCA-negative advanced ovarian cancer patients. This design is aimed at addressing a specific unmet medical need, where PARP inhibitors such as olaparib, which are highly effective as maintenance care in BRCA-mutated ovarian cancer, do not do as well among BRCA-negative patients, who represent the majority of ovarian cancer patients.
Enrolment of first patient
This week, Ultimovacs announced enrolling the first patient for the trial. In a press release, Ultimovacs’ CMO Jens Bjørheim referred to this enrolment as a major milestone for the company:
»The start of recruitment in DOVACC represents another milestone in the expanding clinical program of our lead cancer vaccine UV1. Working with leading specialised 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.«
The importance of DOVACC
The DOVACC study will be conducted at more than 40 hospitals in around 10 European countries coordinated through NSGO-CTU and ENGOT. It includes three arms treating a total of 184 patients. The first arm will enrol 46 patients receiving the PARP inhibitor olaparib, while the 46 patients enrolled in the second arm will receive olaparib and the checkpoint inhibitor durvalumab. The third arm will include 92 patients who will receive Ultimovacs’ UV1 vaccine in combination with both AstraZeneca drugs.
Dr Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of ENGOT, commented on the importance of the DOVACC trial:
»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. The DOVACC study does exactly that by bringing together clinical and commercial organisations in pursuit of a shared goal, in this case extending the effectiveness of maintenance care for ovarian cancer.«
Partially Funded by Innovation Norway
Ultimovacs is well funded for the execution of DOVACC. The company received 10 million NOK (approx. 10 million SEK) from Innovation Norway to support the phase II study. The capital will allow Ultimovacs to continue to implement the company’s clinical development plan and fund its operations through the expected read-out of primary endpoint data in 2023.
That data will assess whether UV1 enhances progression-free survival (PFS) in the treatment arm with solely given olaparib versus the triple combination treatment arm.
Progress in the clinic
The patient enrolment marks a continued progress in Ultimovacs’ clinical programme. DOVACC is one of five ongoing or planned phase II trials with UV1, and the second where a big pharma company joins Ultimovacs in providing the drugs to use in a study – in the NIPU mesothelioma study, Bristol Myers Squibb (BMS) is contributing by providing its checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo).
Given that existing UV1 data indicates a promising ability to reduce the cancer burden across a wide range of indications, the company hopes to continue to attract heavyweight collaborators wanting some of the action.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.