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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriBioteknik
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.
2022-06-23 07:00:14
· The US Food and Drug Administration (FDA) has approved an Investigational New
Drug (IND) Application for the combination of TG01 and QS-21 STIMULONT
· The IND is a major milestone for the TG mutant RAS program, and represents
the first time that a TG vaccine is authorized for clinical trials in the USA

Oslo, Norway, 23 June 2022 - Targovax ASA (OSE: TRVX), a clinical-stage immuno
-oncology company developing immune activators to target hard-to-treat solid
tumors, today announces that the US FDA has approved an IND application for TG01
combined with QS-21 STIMULON, which allows the preparations to initiate clinical
trials in the USA to proceed.

In May, an IND application for the enhanced TG01 mutant RAS cancer vaccine, with
QS-21 STIMULON as adjuvant, was filed with the US FDA. The FDA has now approved
this IND application, which means that the new and improved TG01 version has
been authorized to proceed with clinical studies in the USA.

Targovax has previously demonstrated promising clinical data for an earlier
version of TG01 in KRAS mutant pancreatic cancer. For technical and commercial
reasons, Targovax has made significant improvements in TG01 to strengthen immune
activation and simplify handling at the hospital and improve patient
convenience.

In this new format, TG01 will be co-administered with the FDA approved adjuvant
QS-21 STIMULON, provided by collaboration partner Agenus. QS-21 STIMULON is
expected to enhance TG01 efficacy by driving stronger and broader mutant RAS
immune responses. TG01 and QS-21 STIMULON will be mixed and dosed as a single
injection, rather than two separate injections as in prior trials. Moreover, the
injection will be given sub-cutaneously instead of intra-dermally. These
modifications will make the administration of TG01 more patient friendly and
simpler to manage for healthcare personnel.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, said: "This
IND is a major milestone for our KRAS program, and it is the first time a TG
vaccine receives approval to initiate clinical studies in the USA. We are
confident that the significant upgrades we have made to TG01 will strengthen the
clinical benefit for patients, simplify administration, and make TG01 a more
attractive product overall. We are now working actively with academic centers to
start collaborative clinical studies with the new and improved TG01 vaccine in
mutant RAS cancer patients in 2022."

About QS-21 STIMULON

In March 2022, Targovax announced a collaboration with Agenus to utilize the
proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG
vaccines for future development and commercialization. QS-21 STIMULON has
consistently demonstrated powerful antibody and cell-mediated immune responses
both in cancer trials and commercially as a component of the Shingrix® and
MosquirixT vaccines. QS-21 STIMULON is expected to further potentiate TG by
driving stronger anti-RAS T-cell responses and is routinely co-administered with
vaccines sub-cutaneously.

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 thereby bring benefit
to cancer patients with few available treatment alternatives. Targovax is
assessing its product candidates in different cancer indications, including
melanoma, mesothelioma, multiple myeloma and colorectal cancer, 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 to fight the cancer. On the back of very
encouraging clinical data in several indications, both as monotherapy and in
combinations, ONCOS-102 will progress into a phase 2 trial in multiple
combinations in melanoma patients resistant to PD1 checkpoint blockade.

Building on successful studies demonstrating clinical efficacy and providing
deep mechanistic insights, the ONCOS platform is being expanded into delivery of
circular RNA (circRNA). In addition, Targovax has a KRAS immunotherapy program,
with lead cancer vaccine candidate, TG01, due to enter the clinic in the second
half of 2022. This provides Targovax with a rich pipeline of innovative future
immunotherapy product candidates to follow ONCOS-102.