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Oslo, Norway, 8 May 2019 - Targovax ASA (OSE: TRVX), a clinical stage
biotechnology company developing immune activators to target hard-to-treat solid
tumors, today announces that it has completed patient enrollment in the phase
Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable
malignant pleural mesothelioma (MPM).
The trial consists of a phase Ib safety lead-in part followed by a randomized,
open label phase II part, assessing the combination of ONCOS-102 and standard of
care (SoC) chemotherapy (pemetrexed and cisplatin) vs SoC chemotherapy alone in
first or second/third line patients with unresectable MPM. In May 2018, Targovax
reported no safety issues, strong innate and adaptive immune activation and 50%
disease control rate (DCR) for the six patients in the phase Ib safety lead-in
cohort - see link to press release here (https://www.targovax.com/en/targovax
-announces-early-signal-of-efficacy-in-oncos-102-trial-in-mesothelioma/).
The enrollment of 25 patients into the randomized phase II part of the trial has
now been completed, with a total of 31 patients on the trial who will be
evaluated for safety, immune response and efficacy. There are 20 patients in the
experimental arm combining ONCOS-102 with chemotherapy and eleven patients in
the chemotherapy only control group. The patients in the part I safety cohort
form part of the experimental arm.
The aim of the trial is to assess safety and tolerability, immunological
activation and 6-month overall response rate (ORR) of the combination of ONCOS
-102 and SoC chemotherapy compared to SoC chemotherapy alone. Data read out is
expected around New Year.
Magnus Jäderberg, CMO of Targovax, said: “We are very pleased to have completed
enrollment of our mesothelioma trial. ONCOS-102 is currently the most clinically
advanced oncolytic virus in this difficult to treat cancer, and therefore a high
priority for us. The randomized ORR and immune data from this study will
indicate whether the ONCOS-102 and chemotherapy combination gives patients a
benefit over chemotherapy. The clinical and immune data will guide the further
development of ONCOS-102 in mesothelioma.”
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
(Targovax@fticonsulting.com)
About Targovax
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune
activators to target hard-to-treat solid tumors. Immuno-oncology is currently
one of the fastest growing therapeutic fields in medicine.
Targovax’s lead product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect and
replicate in cancer cells. It has been shown to activate the immune system to
generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced
both local and systemic innate and adaptive immune activation, which has been
associated with clinical benefit. ONCOS-102’s targeted path-to-market indication
is mesothelioma, where the virus is currently being tested in a randomized phase
II trial. Another trial, in checkpoint inhibitor refractory advanced melanoma,
is expected to produce important proof-of-concept immune activation data in
heavily pre-treated patients.
Targovax is also developing a neoantigen cancer vaccine targeting tumors with
oncogenic RAS-mutations, which are known to drive cancer. The TG vaccine program
has shown strong RAS-specific immune activation and a signal of clinical
efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next
generation product candidate, TG02 is currently tested in a phase I trial in
colorectal cancer, both as monotherapy and in combination with Keytruda (an anti
-PD1 check point inhibitor).
http://www.netfonds.no/quotes/release.php?id=20190508.OBI.20190508S22