* 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.
==ENDS==
About Ultimovacs
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.
About Melanoma
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
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
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.