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a non-injected lesion completely regressed
· An online presentation by Targovax’s management will take place at 10:00 CET
2 December 2020 (details below)
Oslo, Norway, 1 December 2020 - Targovax ASA (OSE: TRVX), a clinical stage
immuno-oncology company developing immune activators to target hard-to-treat
solid tumors, today announces that the combination of ONCOS-102 and
pembrolizumab (Keytruda) has demonstrated 35% best objective response rate (ORR)
in anti-PD1 refractory malignant melanoma.
In this two-part, open label phase 1 trial the combination of ONCOS-102 and the
anti-PD1 checkpoint inhibitor (CPI) pembrolizumab has been tested in patients
with advanced, unresectable melanoma who have had disease progression despite
treatment with anti-PD1 CPI. This is a particularly challenging patient
population, which is resistant to approved immunotherapies and has few treatment
alternatives available.
For the trial overall, tumor responses were observed in 7 out of 20 evaluable
patients treated with the ONCOS-102 and pembrolizumab combination, translating
into an ORR of 35% by RECIST 1.1 criteria.
In addition, there were multiple examples of responses in non-injected lesions,
including 2 patients where a non-injected lesion completely disappeared,
indicating that ONCOS-102 can induce systemic anti-tumor immunity.
Prof. Jedd Wolchok, Investigator, Memorial Sloan Kettering Cancer Centre, New
York said: “Checkpoint inhibitors have had a significant impact on the way we
treat melanoma; however, a subset of patients still does not respond or become
resistant to treatment. Therefore, there is a high medical need for immune
activating agents to overcome resistance to checkpoint blockade. ONCOS-102 is
one such agent that can re-sensitize patients to anti-PD1 therapy. Although
these are early data, observing objective responses with some occurring in non
-injected lesions in this first exploratory phase 1 trial is encouraging, and we
will follow with great interest as ONCOS-102 moves forward into later-stage
development.”
The trial was designed with two parts assessing different dosing regimens. In
Part 1, 9 patients were given 3 intra-tumoral ONCOS-102 injections during the
first week, followed by systemic treatment with pembrolizumab every third week
for up to 24 weeks. As reported in July 2019, preliminary tumor responses were
observed in 3 out of 9 patients in at least one CT scan (see link
here (https://www.targovax.com/en/targovax-announces-encouraging-results-from
-part-1-of-the-oncos-102-and-keytruda-combination-trial-in-anti-pd1-refractory
-melanoma/)). 1 patient has since been determined as non-evaluable (trial
inclusion criteria not met), and these numbers have now been updated to 3 out of
8 patients with ORR for Part 1.
12 more patients were enrolled in Part 2 of the trial, where an extended dosing
regimen of 12 intra-tumoral ONCOS-102 injections was tested; 4 injections during
the first two weeks followed by concomitant administration of ONCOS-102 and
pembrolizumab from week 3 and every third week for up to 24 weeks. Tumor
responses were observed in 4 out of the 12 patients in at least one CT scan.
Notably, the patients in Part 2 had markedly more advanced disease than in Part
1, with the majority diagnosed as stage IV metastatic melanoma when entering the
trial. Importantly, both regimens had favorable tolerability profiles, with no
safety concerns.
These data are very strong compared to other therapies in development for the
same indication in combination with anti-PD1 CPI, including TLR-9 agonists and
other oncolytic viruses, which have reported ORR of ca. 25-30%. As such, the
observed ONCOS-102 response rate and effect in non-injected lesions can be
considered class-leading for the treatment of anti-PD1 refractory malignant
melanoma.
Oystein Soug, Chief Executive Officer of Targovax, commented: “These impressive
efficacy data in anti-PD1 refractory melanoma are the most important clinical
results for Targovax to date. The data clearly confirm our hypothesis that ONCOS
-102 can benefit cancer patients resistant to checkpoint inhibition by
triggering local and systemic immune activation. They also provide evidence of
clinical efficacy and establishes ONCOS-102 as one of the most promising
combination partners to checkpoint inhibitors. We will now carefully analyze the
immunological data and are planning for a confirmatory melanoma trial for the
ONCOS-102 and checkpoint inhibitor combination.”
The trial (NCT03003676) was conducted at three sites in the US and one site in
Norway, with Memorial Sloan Kettering CC being the coordinating site.
Online presentation:
Targovax management will present the data in a live webcast 2 December 2020 at
10:00 CET. You can join the webcast
here (https://channel.royalcast.com/landingpage/hegnarmedia/20201202_5/). It
will be possible to ask questions during the presentation. A replay of the
webcast will be available in the Investor section under “Presentations” after
the event.
For further information, please contact:
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 with targeted
therapeutic cancer immunotherapies. The Group’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.
Further, the products are well positioned for combinations with other treatment
approaches, including other immunotherapies, surgery, radiation and
chemotherapy.
Targovax’s lead product 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. ONCOS-102 is currently
being tested in mesothelioma, melanoma and colorectal cancer and has already
shown promising clinical results both as monotherapy and in combination with
chemotherapy, and a checkpoint inhibitor.
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