Targovax receives Fast Track designation for ONCOS-102 in melanoma

· The US FDA grants ONCOS-102 Fast Track designation for PD-1-refractory
advanced melanoma
· Fast Track designation further strengthens the opportunity for accelerated
approval for ONCOS-102 in melanoma

Oslo, Norway 22 June 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 PD-1-refractory advanced melanoma from the US FDA.

The US FDA has granted Fast Track designation to ONCOS-102 based on the current
pre-clinical and clinical data package, including mechanistic evidence showing
an association between ONCOS-102-induced immune activation and tumor responses.
Receiving this designation is an endorsement by the US FDA of the strength and
importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track
designation in malignant pleural mesothelioma.

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 high likelihood of
receiving Priority Review for a future Biologics License Application (BLA) and
may be allowed to submit parts of the application for rolling review to shorten
the approval timeline.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said: "Securing yet
another Fast Track designation is a strong endorsement of the potential for
ONCOS-102 to benefit a patient population with high unmet medical need. Fast
Track simplifies and expedites the regulatory interactions and review process,
and further supports the rationale for initiating a Phase 2 trial to target
accelerated approval for ONCOS-102 in anti-PD1 refractory melanoma".

For further information, please contact:
Oystein Soug, CEO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com

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. Targovax'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.

Targovax's lead clinical 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. On the back of very
encouraging data in several indications, in monotherapy and in multiple
combination, the next development steps for ONCOS-102 will involve a clinical
trial with registration intent in checkpoint inhibitor refractory melanoma.



This information is considered to be inside information pursuant to the EU
Market Abuse Regulation, and is subject to disclosure requirements pursuant to
Section 5-12 of the Norwegian Securities Trading Act. The stock exchange
announcement was published by Renate Birkeli, Investor Relations, Targovax ASA.
https://newsweb.oslobors.no/message/536541