Comprehensive characterization of phase I UV1-checkpoint inhibitor combination trial
Clinical responses seen in patients with favored and less favored baseline characteristics
T cell activation observed post-treatment in tumors of responding patients
Oslo, September 12, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for the treatment of cancer, announced today the publication of data from its phase I melanoma trial in Journal of Translational Medicine.
The clinical data give details of potential additional benefit in the treatment of patients with malignant melanoma from using the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor ipilimumab.
The new data demonstrated highly positive clinical outcome signals. Vaccine-induced immune responses were apparent in 91% of evaluable patients, with strong T cell proliferation demonstrated in peripheral blood, and vaccine-related T cell receptor clones detected in blood and in tumor biopsy. Patients who responded clinically to treatment with UV1 and ipilimumab, also demonstrated an increase in the tumor interferon-gamma signature, a generally accepted predictor for the efficacy of checkpoint inhibitors.
The research team observed clinical responses to the UV1-ipilimumab combination not only in patients with baseline characteristics of high tumor immunogenicity (‘hot’ tumors) but also in patients without (‘cold’ tumors). This breadth of response is noteworthy since ’cold’ tumors are more difficult to treat with checkpoint inhibitors, suggesting that the addition of UV1 vaccination may extend clinical efficacy against these tumor types.
These clinical data further expand upon the previously published safety and feasibility findings from an open-label phase 1/2a clinical trial (NCT02275416) of the combination of UV1 with the CTLA-4 checkpoint inhibitor, ipilimumab. The combination of UV1 and ipilimumab produced an overall response rate (ORR) of 33%. The median progression-free survival (mPFS) among patients treated with UV1 and ipilimumab was 6.7 months, and the median overall survival (mOS) was 66.3 months.
Ultimovacs’ phase II trial, INITIUM, evaluates the combination of the UV1 vaccine combined with both ipilimumab and the PD-1 inhibitor, nivolumab, in the first-line treatment of patients with advanced malignant melanoma. Ultimovacs completed enrollment in INITIUM in June 2022. Topline progression-free survival data from INITIUM are expected in H1 2023.
The new data were published in the Journal of Translational Medicine (JTRM), an open access, peer-reviewed journal. The link to the article can be found on the Company’s website.
Ellingsen, E.B., Bounova, G., Kerzeli, I. et al. Characterization of the T cell receptor repertoire and melanoma tumor microenvironment upon combined treatment with ipilimumab and hTERT vaccination. J Transl Med 20, 419 (2022). https://doi.org/10.1186/s12967-022-03624-z
About the phase I trial with UV1 and ipilimumab in malignant melanoma
This clinical trial evaluated a novel telomerase-targeting therapeutic cancer vaccine, UV1, in combination with ipilimumab, in twelve patients with metastatic melanoma. The trial was an open-label, single-center phase I/IIa study. Eligible patients had unresectable metastatic melanoma. Patients were followed up for progression-free survival (PFS) and overall survival (OS).
The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for UV1 for the treatment of stage IIB – IV melanoma, and Fast Track designation 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