Ultimovacs’ UV1 cancer vaccine shows strong overall survival in malignant melanoma phase I trial
- Category: Vaccines
- Published on Monday, 20 June 2022 11:01
- Hits: 847
- 30 patients treated with UV1/pembrolizumab
- 24-month survival rate of 73%
- Promising survival data follows encouraging clinical response rates and good safety
OSLO, Norway I June 20, 2022 I Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced today positive 2-year overall survival data in its ongoing phase I clinical study of the cancer vaccine UV1 in combination with pembrolizumab for the treatment of malignant melanoma. Across all 30 patients in the study, the 24-month survival rate was 73%. Patients will continue to be followed for long-term survival.
“This result is the latest in a stream of highly encouraging data that indicate the effectiveness of UV1 in enhancing treatment of malignant melanoma. It underlines the potential of UV1 in promoting a concerted immune response in many solid tumor types including those in Ultimovacs’ broader phase II programs.” said Carlos de Sousa, Chief Executive Officer of Ultimovacs. “We have seen consistently more positive outcomes from UV1 in combination with pembrolizumab than with the checkpoint inhibitor alone - higher complete response rates, higher overall response rates, higher median progression-free survival and now better 24-month overall survival rates.”
In the same malignant melanoma study, as reported in March 2022, the complete response rate is 33% (i.e. with complete disappearance of tumors) and the objective response rate is 57% (i.e. with a partial or complete disappearance of tumors). Earlier trials with checkpoint inhibitors have shown that patients with clinical responses have improved survival rates.
The data represent the latest result from Ultimovacs’ phase I study of its universal cancer vaccine UV1 used in combination with the PD-1 checkpoint inhibitor pembrolizumab. Thirty patients were treated in the study in two cohorts that differed only in the concentration of GM-CSF used as a vaccine adjuvant. Two years have passed since the beginning of treatment of the last patient in the second cohort. Ultimovacs expects to provide 3-year overall survival data from the first cohort of 20 patients in Q4 2022.
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. 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.
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 in five cancer indication enrolling more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies, for patients with unmet needs. 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.