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Targovax är ett läkemedelsbolag. Bolaget specialistkompetens återfinns inom riktad immunterapi som används vid behandling av cancerpatienter. Bolagets verksamhet består av forskning och utveckling och läkemedlen säljs idag under separata varumärken. Ett flertal partnerskap på marknaden har ingåtts för att stärka samarbetet inom utvecklingen av ny immunterapi. Bolaget grundades 2010 och har sitt huvudkontor i Oslo.


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2021-02-15 07:00:02
· The US FDA grants ONCOS-102 Fast-Track designation for malignant pleural
· Fast-Track opens the potential for expedited development and review with the

Oslo, Norway 15 February 2021 - 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

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-102Žs 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

About Targovax

Activating the patient's immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing
immune activators to target hard-to-treat solid tumors. Targovax aims to unlock
greater clinical benefits in cancer patients by deploying multifunctional
platforms to target key immune regulators and oncogenic drivers. Targovax's
focus is to "activate the patient's immune system to fight cancer", thus
extending and transforming the lives of cancer patients with targeted
therapeutic cancer immunotherapies. The Group's pipeline aims at different
cancer indications, including melanoma, mesothelioma and colorectal cancer. The
products are designed to harness the patient's own immune system to fight the
cancer, whilst also delivering a favorable safety and tolerability profile.
Further, the products are well positioned for combinations with other treatment
approaches, including other immunotherapies, surgery, radiation and

Targovax's lead product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect cancer
cells and activate the immune system to fight the cancer. ONCOS-102 is currently
being tested in mesothelioma, melanoma and colorectal cancer and has already
shown promising clinical results both as monotherapy and in combination with
chemotherapy, and a checkpoint inhibitor.