Ultimovacs has announced data showing that the company’s universal cancer vaccine UV1 in combination with ipilimumab induces dynamic, multi-functional T cell responses in patients with melanoma, with the potential for protection of 5 years or more.
The data will be presented as a poster at the Society For Immunotherapy of Cancer’s 36th Annual Meeting (SITC2021) being held in Washington, DC, USA November 10-14, 2021.
An early Ultimovacs’ Phase I/IIa study
The SITC2021 data are from an early Ultimovacs’ Phase I/IIa study of UV1 with the checkpoint inhibitor ipilimumab in twelve patients with melanoma (NCT02275416). They show that the drug combination induces a T cell immune response in 91% of patients, and that the response can persist as long as 5 years (the end of the study period). The UV1-ipilimumab combination induces T cells that are polyfunctional and produce multiple effector cytokines such as interferon-gamma and TNF-alpha essential for a robust anti-tumor response. Tumor biopsies revealed an influx of tumor-infiltrating lymphocytes (TIL) in patients who responded well to treatment. The finding is a positive early signal in a broader R&D program aimed at documenting the mechanistic effects of UV1.
“These are pleasing and clear data. The UV1-induced T cells continue to respond dynamically to the presence of antigen over a prolonged period. The longevity of the induced immune response and the persisting proliferative capacity of the T cells provide optimism for UV1’s potential to provide long-term clinical impact for the patients,” says Gustav Gaudernack, Chief Scientific Officer of Ultimovacs. “Ultimovacs is delighted to be able to share these data with the scientific and clinical community at SITC. As a company, we remain committed to progressing UV1 in our ongoing Phase II clinical studies.”
UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer (NSCLC).
In total, the five Phase II trials will enroll more than 650 patients at nearly 100 clinical centers across 15 countries. The U.S. FDA recently granted Fast Track designations to the combinations of UV1 with ipilimumab and UV1 with pembrolizumab in the treatment of advanced malignant melanoma.
Photo of Gustav Gaudernack: Ultimovacs