Advanced Ovarian Cancer Vaccine Study Doses 1st Patient
Norway-based Ultimovacs ASA announced today that the first patient had been enrolled in the DOVACC (Durvalumab Olaparib VACCine) study, a randomized Phase II clinical trial assessing the impact of the telomerase vaccine, UV1, on the standard of maintenance care in ovarian cancer.
DOVACC will assess whether UV1 enhances progression-free survival in BRCA-negative (BRCA wild type) advanced ovarian cancer combined with two AstraZeneca drugs, durvalumab and olaparib.
The primary outcome measure for DOVACC is progression-free survival for the UV1-durvalumab-olaparib triple combination versus olaparib alone. The topline DOVACC study data is expected in 2023.
DOVACC will recruit 184 patients across Europe from a network of more than 40 hospitals.
DOVACC is one of five randomized Phase II clinical trials of Ultimovacs' UV1 combined with other immunotherapies.
In 2021, the U.S. FDA granted Fast Track designation to UV1 as an add-on therapy to ipilimumab or 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.
Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of ENGOT, commented in a press release, "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."
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.
Innovation Norway granted Ultimovacs NOK 10 million ($1.2 million) to support the Phase II DOVACC study execution.