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
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum - Corporate
Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
IR enquires:
Kim Sutton Golodetz - LHA Investor
Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/targovax/r/targovax-receives-fast-track-designation-for-oncos-102,c3286718
View original
content:http://www.prnewswire.com/news-releases/targovax-receives-fast-track-designation-for-oncos-102-301228114.html
SOURCE Targovax