New clinical data from phase I trial UV1-103, combining UV1 with pembrolizumab in advanced melanoma will be presented
Oslo, September 21 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced today that further data from its clinical study on the combination of its universal cancer vaccine, UV1, and the PD-1 checkpoint inhibitor, pembrolizumab, will be disclosed in an oral presentation at the 19th International Congress of the Society for Melanoma Research (SMR) on 18 October 2022.
The presenter will be Dr. Yousef Zakharia, Investigator for the UV1-103 clinical trial. Dr. Zakharia is a Medical Oncologist, Clinical Associate Professor and Director Phase I Program at University of Iowa Hospital and Clinics.
“I am pleased to present the results from the UV1-103 trial to international peers in melanoma research”, said Dr. Yousef Zakharia. Carlos de Sousa, CEO of Ultimovacs added: “As Ultimovacs’ five randomized phase II trials of UV1 continue to mature, there is growing interest in the ability of the vaccine to induce long-lasting, survival-associated immune responses. We are honored to be able to present further data on the clinical activity of UV1.”
Ultimovacs’ presentation is entitled ‘Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Unresectable Melanoma’ and will be given as an oral presentation at the International Congress of the Society for Melanoma Research. Society for Melanoma Research will be online and in-person in Edinburgh, UK, October 17 - 20, 2022. The congress brings together the leaders in the field of basic and translational melanoma research and melanoma clinical trial physicians from around the world.
The presentation will be made available at the Company website on October 18, 2022.
About the UV1-103 phase I trial in Malignant Melanoma
This US-based Phase I clinical trial is evaluating the Company’s lead candidate, UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The clinical results for the 30 patients enrolled are:
Objective response rate (ORR): 57%, complete response rate (CR): 33%
Median Progression Free Survival (mPFS): 18.9 months (as measured by iRECIST)
Overall survival after 12 months: 87%, overall survival after 24 months: 73%
Patients will continue to be followed for long-term survival. UV1 has demonstrated a good safety profile, and no unexpected safety issues related to UV1 have been observed in this trial.
The U.S. Food and Drug Administration (FDA) granted a dual Fast Track designation for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.
Ultimovacs is an immunotherapy company 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 indications 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.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Anne Worsøe, Head of Investor Relations
Phone: +47 906 86 815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853