Targovax announces that the TG01 study in multiple myeloma at Oslo University Hospital has received regulatory approvals to proceed

22 Dec 2022 07:00 CET

· The Norwegian Medicines Agency (NOMA) and the Regional Ethics Committee (REK)
have today approved the clinical trial application for TG01 in multiple myeloma

· The Norwegian Medicines Agency (NOMA) and the Regional Ethics Committee
(REK) have today approved the clinical trial application for TG01 in multiple
myeloma
· It is expected that the study will open, and the first patient will be
enrolled at Oslo University Hospital (OUS) in early 2023

Oslo, Norway, 22 December 2022 - Targovax ASA (OSE: TRVX), a clinical-stage
immuno-oncology company developing immune activators to target solid tumors,
today announces that the planned clinical trial with mutant RAS cancer vaccine
TG01 in multiple myeloma has received regulatory approval to proceed from NOMA
and REK.

The trial is a collaboration between OUS and Targovax and will test TG01
vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma
patients who continue to have measurable disease after completion of standard of
care treatment. The aim is to assess whether anti-RAS T-cell priming induced by
TG01 can enhance the clinical response.

The trial will be sponsored by OUS and led by Dr. Fredrik Schjesvold, an
international leader in the field and founder of the Oslo Myeloma Center, the
largest Myeloma center in the Nordics. Targovax will provide TG01 drug supply,
scientific support and a financial contribution through grants awarded from
Innovation Norway and the Norwegian Research Council.

Dr. Ingunn Munch Lindvig, VP & Head of Regulatory Affairs, Targovax ASA, said:
"We are very pleased that the planned collaborative studies for the TG mutant
RAS program continue to obtain the necessary regulatory approvals to proceed in
both the EU and USA. The multiple myeloma trial plan is now approved both by the
Norwegian regulatory agency NOMA and the ethics committee REK under the new
European system, and Oslo University Hospital can proceed with identifying
patients for inclusion into the trial."

For further information about the study and collaboration structure, please see
here (https://www.targovax.com/en/targovax-and-oslo-university-hospital-announce
-collaboration-to-test-tg-mutant-ras-vaccination-in-multiple-myeloma/).

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@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

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's focus is to
activate the patient's immune system to fight cancer, and to bring benefit to
cancer patients with few available treatment alternatives. Targovax is
developing its product candidates in different cancer indications, including
melanoma, mesothelioma, and multiple myeloma, and has demonstrated 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 against the tumor. Following very
encouraging clinical data in several indications, both as monotherapy and in
combinations, ONCOS-102 is progressing into a randomized phase 2 trial in
melanoma patients resistant to PD-1 checkpoint inhibitor treatment.

Building on successful clinical studies which have provided deep mechanistic
insights into the tumor biology and the human immune systems, Targovax is
researching circular RNA (circRNA) as novel cancer medicines. In addition,
Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate,
TG01, expected to enter the clinic in an enhanced format in the second half of
2022. Together this provides Targovax with a rich pipeline of innovative future
immunotherapy product candidates to follow ONCOS-102.

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