OSLO, Norway, Feb. 15, 2021 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that its lead clinical candidate ONCOS-102 has received Fast-Track designation in malignant pleural mesothelioma from the US FDA.
The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package.
The FDA Fast Track-designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast-Track products have improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.
The Fast-Track approval comes in addition to ONCOS-102’s existing Orphan Drug Designation (ODD) with both the US FDA and European EMA in the mesothelioma indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in the USA and EU, respectively, from the date of BLA grant.
Dr. Ingunn Munch Lindvig, VP Regulatory Affairs, said: “Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program. Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need”.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Kim Sutton Golodetz – LHA Investor Relations (US)
Phone: +1 212-838-3777
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