Targovax Gets FDA Fast-Track Designation for ONCOS-102 in Melanoma

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 [e-mail]

(END) Dow Jones Newswires

06-22-21 0907ET