Targovax Gets FDA Fast-Track Designation for ONCOS-102 in Melanoma
June 22 2021 - 9:19AM
Dow Jones News
By Colin Kellaher
Targovax ASA Tuesday said the U.S. Food and Drug Administration
granted fast-track designation to ONCOS-102, the company's lead
clinical candidate, in PD-1-refractory advanced melanoma.
The Lysaker, Norway, clinical-stage immune-oncology company said
the designation is based on its current pre-clinical and clinical
data package, including mechanistic evidence showing an association
between ONCOS-102-induced immune activation and tumor
responses.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of treatments for serious or
potentially life-threatening illnesses with high unmet medical
needs.
Targovax previously received fast-track designation for
ONCOS-102 in malignant pleural mesothelioma.
Targovax shares rose nearly 6% Tuesday to NOK8.99.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 22, 2021 09:07 ET (13:07 GMT)
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