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ListaOB Match
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.
2022-09-27 07:00:14
· The US Food and Drug Administration (FDA) has reviewed and accepted the
protocol for the ONCOS-102 phase 2 combination trial in PD-1 checkpoint
inhibitor (CPI) refractory advanced melanoma
· The study is on track to start in late 2022 or early 2023

Oslo, Norway, 27 September 2022 - Targovax ASA (OSE: TRVX), a clinical-stage
immuno-oncology company developing immune activators to target solid tumors,
today announces that the FDA has accepted the protocol and given the formal go
-ahead to proceed with the planned ONCOS-102 phase 2 trial in melanoma. Study
initiation activities are proceeding according to the communicated timeline,
with the aim to start enrolling patients in late 2022 or early 2023.

PD-1 CPI refractory advanced melanoma is a major unmet medical need affecting up
to 25,000 patients per year globally in the major markets. The diagnosis has
poor prognosis and there are currently no approved treatment options available.
In a recently reported phase 1 trial, ONCOS-102 demonstrated a highly
competitive response rate (ORR) of 35% in this patient population in combination
with a PD-1 CPI. Importantly, the strong ORR outcome was corroborated by
biomarker data showing significant increase in T-cell infiltration and broad and
persistent activation of immune-related gene signatures in responding patients.

Based on these promising early clinical results, Targovax is planning to conduct
a larger, phase 2 multi-cohort study to further explore and validate the benefit
of ONCOS-102 in PD-1 CPI refractory melanoma. This phase 2 study will be run in
collaboration with Targovax's partner Agenus, who will provide their Fc-enhanced
CTLA-4 (botensilimab) and PD-1 (balstilimab) CPIs for combination with ONCOS

In the first part of the study, two groups will evaluate the safety and efficacy
of (1) a higher dose of ONCOS-102 to be tested as a monotherapy and (2) the low
and new higher dose of ONCOS-102 in combination with the PD-1 CPI balstilimab.
Following confirmation of the safety of the increased ONCOS-102 dose, the study
will proceed into its second part adding two more groups. In group (3) ONCOS-102
will for the first time be combined with a CTLA-4 CPI (botensilimab) and,
ultimately, in (4) the triple combination of ONCOS-102, balstilimab and
botensilimab will be tested.

Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: "We are very
pleased to get the formal go-ahead from the FDA for our phase 2 melanoma study.
With the proposed design, we will answer important clinical questions relating
to safety, dosing and contribution of components that are critical to enable
subsequent registrational trials. I am particularly excited about the
combination with the next generation Fc-enhanced CTLA-4 CPI botensilimab, which
is expected to enhance systemic activity and deepen tumor responses. We
anticipate that the triple combination of ONCOS-102 with PD-1 and CTLA-4
blockade will boost response rates above the already strong 35% ORR, and firmly
establish ONCOS-102 as class-leading candidate in PD-1 CPI refractory melanoma".

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 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 studies demonstrating clinical efficacy and providing
deep mechanistic insights, the Targovax 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.