Targovax ASA: Interim report fourth quarter 2015

• Integration process continues, utilizing cross organization expertise and exploring advantages in   combining product platforms
   
• Extending studies through external collaborations. Entered agreements with US Ludwig Cancer Research (LICR)/Cancer Research Institute (CRI) and the Czech biotech company Sotio.
   
• Progressed the preparation of three new Targovax sponsored combination clinical trials according to plan. Study protocols have been finalized for two of the three trials, with study documentation submitted to the health authorities in Spain for the mesothelioma trial in the first quarter 2016
   
• Presented immune biomarker data from a phase I study at the SITC conference, suggesting that local immunotherapy with ONCOS-102 has the potential to activate immunologically silent tumors and reduce local immune suppression in advanced tumors
   
• Fourth quarter 2015 operating expenditures of NOK 42 million. Current cash holdings secure funding through 2H 2016.

       

LYSAKER, Norway, March 2, 2016 (GLOBE NEWSWIRE) -- "We are very satisfied with the progress in our clinical programs, which will result in multiple readouts in the next few years. Further, the agreements with external partners is a recognition of our technology, and will result in new clinical trials", says Gunnar Gårdemyr, CEO of Targovax.

Targovax is the owner of two established technologies with promising phase I data. TG01 is the only RAS-specific vaccine currently in development, while ONCOS-102 is the only viral cancer immunotherapy shown to induce tumor specific cellular immunity in humans. With these two product candidates, Targovax has established a solid platform for further development of its clinical stage targeted immunotherapy treatments for cancer patients.

The TG01 Pancreatic cancer Phase II trial is progressing as planned. In a first cohort, 19 patients have received the combined treatment and of the 18 patients eligible for immune response assessment. Of the 19 patients, 15 (83%) have established a detectable immune response. A modified vaccination regimen intended to minimize DLTs has been introduced, and up to 13 patients will be included in this new cohort. The study centers are open and actively recruiting patients.

ONCOS-102 in Mesothelioma, a randomized phase II open label study plans to include 30 patients. The study will to commence during the second half of 2016, with the site ready for recruitment in the first half.

Reporting material
The quarterly report and the presentation material is available on www.targovax.com.

Presentation at 09:30 CET
Targovax will hold a presentation of the results on Wednesday 2 March at 09:30 CET at Hotel Continental Conference Centre, Stortingsgaten 24/26, Oslo, Norway. CEO Gunnar Gårdemyr, CFO Øystein Soug and CMO Magnus Jäderberg will be representing the company.

Conference call
At 14:00 CET (08:00 EST) the same date, the company will host a telephone conference, including a presentation of the results, following with a Q&A session. Call in details below.

Call in numbers:
Norway Toll-Free Number: 800 19 747
Norway Toll Number: +472350 0559
UK Toll-Free Number: 08082370030
UK Toll Number: +442031394830
US Toll-Free Number: 1866 928 7517
US Toll Number: +1 718 873 9077

Access code: 16490430#

Please make sure to dial in at least 5-10 minutes ahead of time to complete your registration.

See attached list for more dial in numbers.
http://wpc.1726.planetstream.net/001726/FEL_Events_International_Access_List.pdf

For further information, please contact
Gunnar Gårdemyr
CEO
Phone: +41 798 340 585
Email: ggardemyr@targovax.com

Øystein Soug
CFO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com

"Arming patient's immune system to fight cancer"

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a leader in its area. The company is currently developing two complementary and highly targeted approaches to immuno-oncology:

ONCOS-Oncos 102 is part of a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment may reinstate the immune system's capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancers and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

The product candidates will be developed in combination with multiple treatments in several cancer indications, including checkpoint inhibitors. Targovax also has a number of other cancer immune therapy candidates in early stage of development.

Targovax Q4 presentation http://hugin.info/171039/R/1990629/731413.pdf
Targovax Q4 report http://hugin.info/171039/R/1990629/731420.pdf

HUG#1990629