Targovax and SOTIO announce first patient dosed in Phase I/II combination trial of ONCOS-102 with DCVAC

Oslo, Norway, 12 July 2018 - Targovax ASA (OSE: TRVX), a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, and SOTIO, a biotechnology company owned by the PPF Group, announce that the first patient has been dosed with ONCOS-102 in the SP015 phase I/II clinical trial in patients with prostate cancer, combining the Company’s immune-priming adenovirus ONCOS-102, with SOTIO’s DCVAC/PCa, an active cellular immunotherapy.

The first patient has been dosed with ONCOS-102 at the Motol University Hospital in Prague, by the principal investigator Dr. Ladislav Jarolím. One additional trial site is planned to be opened in the UK later this year.

SP015 (Eudra CT: 2015-004314-15) is a Phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of ONCOS-102 and DCVAC/PCa in men with advanced metastatic castration-resistant prostate cancer. The study aims to enroll up to 15 patients across centers in the Czech Republic and United Kingdom. The trial builds on the hypothesis that ONCOS-102 may enhance the anti-tumor immune responses generated by dendritic cells loaded with tumor antigens, and thus may help the immune system to overcome evasion strategies employed by tumors.

“We are excited to have started our fourth combination study of ONCOS-102, which will examine safety, immune activation and efficacy alongside DCVAC/PCa in prostate cancer patients.” said Magnus Jäderberg, CMO of Targovax. “Finding the right combination treatments is crucial to boost the response rate to immunotherapies, and in this particular trial we are testing the hypothesis of whether intratumoral delivery of ONCOS-102 and its transgene payload, GM-CSF, can provide a trafficking signal that enhances recruitment of the DCVAC dendritic cells to the prostate tumor site.”

Radek Špíšek, CEO of SOTIO, said: “By combining an autologous active cellular therapy with an oncolytic virus, we had to overcome various regulatory and operational challenges. We are very happy to have succeeded in initiating such complex trial, the first of its kind ever conducted in Czech Republic and the CEE region. The SP015 clinical trial will help us to gather critical evidence necessary to develop innovative immunotherapies for the treatment of cancer that threatens one in five men globally.”

About ONCOS-102

Targovax’s proprietary ONCOS platform uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS-102 is Targovax’s lead adenovirus-based pipeline product – a purposefully engineered human serotype 5 adenovirus optimized to induce systemic anti-tumor T cell responses in cancer patients. ONCOS-102 has completed a Phase I clinical study and is being tested in further combination clinical trials in several solid tumor indications.

About DCVAC/PCa:

DCVAC/PCa was the first SOTIO product to enter clinical research. DCVAC/PCa is an active cellular immunotherapy treatment for prostate cancer patients; DCVAC/PCa is produced individually for each patient using the patient’s own dendritic cells (that are part of the immune system), to induce an immune reaction against tumor antigens. SOTIO has been sponsoring five Phase II clinical trials and one global Phase III (VIABLE) clinical trial in patients with prostate cancer. Another Phase II and Phase I/II clinical trials are conducted in ovarian cancer and lung cancer indications.

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 cancer

Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

Targovax’s primary product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, used as potential multi-target, neo-antigen therapeutic cancer vaccines. It has been engineered as an immune activator that selectively targets cancer cells. In phase I trials it has demonstrated immune activation at lesional level which was associated with clinical benefit. ONCOS-102’s lead indication is mesothelioma where the virus is currently being developed in a phase II trial. A second trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients.

In addition, Targovax has a neo-antigen cancer vaccine under development targeting tumors that express mutated forms of RAS. Key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival. A next generation product candidate, TG02 is currently being combined with pembrolizumab in a phase I trial in colorectal cancer.

Both platforms are protected by an extensive portfolio of IP, know-how, and have the potential to yield multiple product candidates.

About SOTIO

SOTIO is an international biotechnology company leading the efforts of PPF Group to build a diverse biotechnology portfolio through its own research & development, collaborations, in-licensing, investments, mergers and acquisitions. The company is developing new medical therapies, focusing on the treatment of cancer and autoimmune diseases. SOTIO’s most advanced project is its proprietary platform of active cellular immunotherapy (ACI) based on dendritic cells. SOTIO is conducting multiple Phase I to Phase III clinical trials verifying the safety and efficacy of its DCVAC products. SOTIO is also collaborating with NBE Therapeutics on the development of novel antibody-drug conjugate products (ADC), with Cytune Pharma on developing novel IL15-based immunotherapies for the treatment of cancer and with LDC and Max Planck on an oncology program addressing a novel target in tumor metabolism. SOTIO has facilities in Europe, the United States, China and Russia. For more information about the company visit the website www.sotio.com.

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