TRVX-Targovax announces that first combination trials with

11.12.2017 kl 07:14

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Targovax announces that first combination trials with ONCOS-102 have passed their initial, planned, independent safety reviews

Oslo, Norway, 11 December 2017 - Targovax ASA (OSE: TRVX), a clinical stage
company focused on developing immuno-oncology therapies to target solid tumors,
announces that clinical trials investigating ONCOS-102 in the treatment of
melanoma and mesothelioma have successfully passed their respective first,
planned, independent safety reviews. These are the first studies to investigate
ONCOS-102 in combination with other drugs.

The safety reviews of ONCOS-102 in the first four patients in the melanoma trial
and first three patients in the mesothelioma trial have been completed without
any safety concerns. The review reports conclude that, to date, ONCOS-102 has
been well-tolerated in combination with either checkpoint inhibitor
(KEYTRUDA(®)), or chemotherapy (pemetrexed/cisplatin), and both trials were
recommended to be continued by the study-specific safety committees.

The melanoma trial is an open-label phase I trial exploring the safety, immune
activation and clinical response of sequential treatment with ONCOS-102 and the
checkpoint inhibitor KEYTRUDA(®) (pembrolizumab, an anti-PD-1 monoclonal
antibody) in patients with advanced or unresectable melanoma, whose tumors have
continued to grow despite checkpoint inhibitor therapy. The goal of the trial is
to investigate whether the immune system of patients, who have already failed to
respond to checkpoint inhibitors, can be reactivated by priming with ONCOS-102
and whether this reactivation enables them to respond to subsequent retreatment
with a checkpoint inhibitor.

The mesothelioma trial is a randomized phase II, open-label, multi-center trial
with a phase Ib safety lead-in of ONCOS-102 and standard of care
pemetrexed/cisplatin (chemotherapy) in patients with unresectable malignant
pleural mesothelioma. The trial will include six patients in a lead-in to
evaluate safety, followed by a randomized part of the trial to compare the
combination treatment with the standard of care chemotherapy.

Dr Magnus Jäderberg, CMO of Targovax, said: "We are pleased that the first
combination trials of ONCOS-102 have passed the initial safety reviews without
any issues. As such, ONCOS-102 appears to be well-tolerated in combination with
both checkpoint inhibition and chemotherapy, and we can proceed with the trials
as planned. Our plan now is to evaluate immune responses in the first subset of

Immune response data readout schedule
Over the coming weeks and months, Targovax expects to release immune response
data in a subset of patients for these two trials, in addition to the TG02 RAS
neo-antigen vaccine trial in colorectal cancer, according to the following
* In December: TG02 in colorectal cancer
* In January: ONCOS-102 in melanoma
* In February: ONCOS-102 in mesothelioma

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Redigert 11.12.2017 kl 07:21 Arkivert