Targovax ASA: Second quarter and first half year 2018 results

Oslo, Norway, 23 August 2018 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors, today announces its second quarter and first half year 2018 results.

A meeting for investors, analysts and press will take place in Oslo today at 10:00 CET (details below).

HIGHLIGHTS FOR THE SECOND QUARTER AND FIRST HALF YEAR 2018

• In January, Targovax announced that ONCOS-102 generated immune activation at both the systemic and lesional levels in checkpoint inhibitor (CPI) refractory melanoma in four out of the first four patients treated

• In February, Targovax announced that the safety lead-in part of its ONCOS-102 trial in unresectable, malignant, pleural mesothelioma was completed without any safety concerns, and that ONCOS-102 generates early immune activation in treated patients

• In May, an early signal of efficacy was reported from the ONCOS-102 phase I/II trial in mesothelioma, with activity observed in three out of six patients in the safety lead-in cohort. The trial has now entered the randomized phase II part, enrolling 24 more patients

• In May, survival data was reported from the 32-patient phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in combination with gemcitabine chemotherapy. Median overall survival for the patients vaccinated with TG01 was 33.4 months, compared with 27.6 months for gemcitabine alone reported in the ESPAC4 trial

• In June, the Company updated its business strategy, strengthening the development focus on the ONCOS oncolytic virus program, with ONCOS-102 as the lead product candidate

• In June, Targovax was granted a product patent in the EU for TG02, the 2nd generation product from the mutant-RAS neoantigen vaccine platform

• In April, Dr. Catherine A. Wheeler was elected as a new member of the Board of Directors

POST-PERIOD HIGHLIGHTS

• In July, Ludwig Cancer Research and CRI announced the completion of the safety evaluation for the first dose cohort in the phase I/II trial of ONCOS-102 in combination with MedImmune’s checkpoint inhibitor Imfinzi® (durvalumab)

• In July, Targovax and SOTIO announced that the first patient was dosed in the phase I/II combination trial of ONCOS-102 with DCVAC, a dendritic cell immune-therapy

Øystein Soug, CEO said: “It has been an exciting first half of 2018 for the oncolytic virus field. Clinical data, both from Targovax and others, have reinforced the scientific foundation of oncolytic viruses as an important class of immune activators. Oncolytic virus therapies have been further highlighted by recent deal activity in the space. Therefore, it is natural for Targovax to strengthen its efforts on the ONCOS program. We look forward to several upcoming data read-outs within the next year. We continue to see potential in the TG neo-antigen cancer vaccine to treat mutant RAS cancers, and are working closely with our scientific advisors to devise an updated strategy for how to best create value for both patients and shareholders. We aim to announce a revised development plan for the TG program during the autumn.”

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Presentation 

The presentation will take place at 10:00 CET at:

Hotel Continental
Stortingsgaten 24/26
0117 Oslo

The presentation will also be webcast live and can be accessed through www.targovax.com.

Reporting material

Targovax second quarter and first half 2018 report

Targovax second quarter and first half 2018 presentation

The quarterly report and presentation are also available at the website www.targovax.com.

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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

Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com  

About Targovax

Activating the patient's immune system to fight cance

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 is used as a therapeutic cancer vaccine and 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 lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients within the next 6-12 months.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS - mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with Keytruda® (an anti-PD1 Check point inhibitor, CPI).