- Designation covers UV1 in Metastatic Melanoma as sole agent or part of combination
- Seven-year market exclusivity after regulatory approval, if received
Oslo, 2 December 2021: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company’s universal cancer vaccine UV1 for the treatment of stage IIB – IV melanoma. UV1, as add-on therapy to checkpoint inhibitors ipilimumab and nivolumab, is currently being studied as first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.
The FDA Office of Orphan Products Development (OOPD) supports and advances the development and evaluation of new treatments for rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including seven-year market exclusivity upon regulatory approval if received, exemption from FDA application fees and tax credits for qualified clinical trials.
In October this year, 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.
“We are very pleased to have been granted this orphan drug designation for UV1 in treating metastatic melanoma. The designation underlines the promise of UV1 that has been shown in our clinical studies in metastatic melanoma to date,” said Carlos de Sousa, CEO of Ultimovacs. “We remain committed to further investigating UV1 in our ongoing Phase II clinical studies and to continuing our constructive dialog with regulators to bring UV1 to patients as soon as possible.”
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.
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, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. 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.
Melanoma is the fifth most common cancer in both men and women in the U.S., with more than 100,000 new cases of melanoma diagnosed every year. Ultimovacs’ INITIUM clinical trial uses UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab to treat metastatic melanoma (Stage III – IV melanoma), including the later stages of the disease in which the melanoma has spread to lymph nodes and/or to more distant parts of the body. In addition to surgery or radiation therapy, checkpoint inhibitors have become standard of care treatment for metastatic melanoma. The 5-year survival rate for patients with Stage IV metastatic melanoma is approximately 20-30%.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on December 2, 2021 at 19:00 CET.