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· Broad and powerful immune activation pattern observed in patients treated
with ONCOS-102, clearly associated with both tumor responses and survival
outcomes
Oslo, Norway, 10 June 2021 - Targovax ASA (OSE: TRVX), a clinical-stage immuno
-oncology company developing immune activators to target hard-to-treat solid
tumors, today announces mOS between 21.9 and 25.0 months from the randomized
phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC)
chemotherapy in patients with malignant pleural mesothelioma (MPM).
For information in Norwegian, press this
link. (https://mb.cision.com/Public/17093/3364714/b95e6ec6e1a750da.pdf)
The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC
chemotherapy (pemetrexed/cisplatin) in first- and second- (or later) line MPM to
assess safety, immune activation and clinical efficacy compared with SoC alone.
A total of 31 patients were enrolled in the trial, with 20 patients in the
treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in
the control group receiving SoC only. The trial has now completed the 24-month
follow-up.
At the 24-month follow-up, it was determined that the final mOS will be in the
range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the
randomized group (n=8). This is a clear improvement over the mOS of 13.5 months
observed in the first-line SoC-only control group (n=6). Previous MPM clinical
trials have reported mOS in the range of 12-16 months for patients receiving the
same SoC chemotherapy treatment[1].
Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102
treatment (Day 36). The tumor tissue analyses revealed broad and powerful ONCOS
-102-induced remodeling of the tumor microenvironment with increased T-cell
infiltration and a shift towards pro-inflammatory immune cells, far beyond what
was observed for the SoC-only control group. Notably, this activity was
associated with both tumor responses and survival outcomes, indicating that the
immune activation generated by ONCOS-102 is driving the clinical benefit for
patients.
Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the Hospital Doce
de Octubre, Madrid and Principal Investigator of the trial, said: “Mesothelioma
remains a challenging disease with a generally poor prognosis, and there is a
large unmet medical need for new, innovative treatments such as ONCOS-102.
Although the number of patients in this trial is small, the overall survial is
very encouraging, particularly since the outcomes can be linked to ONCOS-102
-induced immuno-modulation. These early results clearly support further clinical
development, and we look forward to participating in future trials with ONCOS
-102 in mesothelioma.”
Recently, the double checkpoint inhibitor (CPI) combination of Opdivo and Yervoy
(nivolumab and ipilimumab) was approved by the U.S. Food and Drug Administration
(October 2020) and the European Medicines Agency (April 2021) for the first-line
treatment of MPM, based on a phase 3 trial showing mOS of 18.1 months compared
with 14.1 months in the SoC control group (pemetrexed/cisplatin). The
Opdivo/Yervoy combination is seeing rapid uptake among clinicians in both the
USA and Europe and is becoming the new preferred first-line Standard of Care.
Given the class-leading activity ONCOS-102 has demonstrated in CPI-refractory
melanoma (see link here (https://www.targovax.com/en/targovax-announces
-impressive-objective-responses-as-well-as-effects-on-non-injected-lesions-in
-oncos-102-trial-in-anti-pd1-refractory-melanoma-patients/)), Targovax believes
there is a strong scientific rationale for testing ONCOS-102 in the CPI
-refractory setting also in MPM. This opportunity is now being discussed with
key opinion leaders.
Øystein Soug, CEO of Targovax, commented: “We are very pleased to see ONCOS-102
generating robust immune activation in a tumor type with low immunogenicity and
delivering meaningful survival benefit for patients with high medical need. With
the recent approval of the Opdivo/Yervoy combination, the power of immunotherapy
is now making its way into mesothelioma and is already improving patient
outcomes. ONCOS-102 is ideally positioned for combination with checkpoint
inhibitors and, as demonstrated in our melanoma trial, to reactivate checkpoint
resistant tumors. Therefore, we are now evaluating the potential opportunity in
the emerging checkpoint resistant mesothelioma population, thereby expanding on
the demonstrated ability of ONCOS-102 to bring benefit to the majority of
patients who still progress after checkpoint inhibitor treatment.”
[1] 1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019,
Baas 2020 SITC 2020 poster
For further information, please contact:
Øystein Soug, CEO
Phone: +47 906 56 525
Email: oystein.soug@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
IR enquires:
Kim Sutton Golodetz - LHA Investor Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777
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 aims to unlock
greater clinical benefits in cancer patients by deploying multifunctional
platforms to target key immune regulators and oncogenic drivers. Targovax’s
focus is to “activate the patient’s immune system to fight cancer”, thus
extending and transforming the lives of cancer patients. Targovax’s pipeline
aims at different cancer indications, including melanoma, mesothelioma and
colorectal cancer. The products are designed to harness the patient’s own immune
system to fight the cancer, whilst also delivering 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 data in several indications, in monotherapy and in multiple
combination, the next development steps for ONCOS-102 will involve a clinical
trial with registration intent in checkpoint inhibitor refractory melanoma.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation, and is subject to disclosure requirements pursuant to
Section 5-12 of the Norwegian Securities Trading Act. The stock exchange
announcement was published by Renate Birkeli, Investor Relations, Targovax ASA.
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