Targovax announces that ONCOS-102 generates immune activation in checkpoint inhibitor refractory melanoma patients

Oslo, Norway, 4 January 2018 - Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces immune activation data in the first four patients treated with ONCOS-102 followed by the checkpoint inhibitor (CPI) pembrolizumab (KEYTRUDA^®) in patients with advanced melanoma whose disease has progressed after prior CPI treatment.

This is the first time ONCOS-102 has been used therapeutically in melanoma patients, and also the first time the virus has been administered to CPI refractory patients. In this Phase I open label study, patients are scheduled to receive three intra-tumoral ONCOS-102 injections during the first week, and thereafter subsequently re-challenged with the programmed cell death protein 1 (PD-1) blocking CPI KEYTRUDA^®. As reported in December, the first planned safety review passed without any issues, and the trial was recommended to continue (December press release).

To date, four patients have been treated with ONCOS-102, and immune activation has been assessed at week 3. Early systemic immune activation in all four patients was indicated by:

• Increase of several pro-inflammatory cytokines
• Increase of the relative level of cytotoxic CD8+ T-cells
• Increase of PD-1 expression on CD8+ T-cells

These data indicate that ONCOS-102 may induce both an innate and adaptive immune activation in CPI refractory patients. In addition, increased PD-1 expression on the surface of CD8+ T-cells after ONCOS-102 treatment suggests that the tumors may be susceptible to re-challenge with KEYTRUDA^®.

Magnus Jäderberg, CMO of Targovax, said: "After the positive safety review reported in late 2017, we are very pleased to now also be able to confirm immune activation in checkpoint inhibitor refractory melanoma patients. These results are in line with data reported in our completed all-comers phase I trial, but this is the first time we have treated melanoma patients. It will be interesting to see if the immune activation and increased PD-1 expression on CD8+ T-cells will have an impact on clinical outcome after re-challenge with KEYTRUDA^®_."

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected] 

Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]

Julia Phillips/Simon Conway - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: [email protected]   

About Targovax

Arming the patient's immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

The Company's development pipeline is based on two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be 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. In an ongoing phase I trial in advanced melanoma we expect important proof of concept data for checkpoint inhibitor refractory patients.

The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of RAS. Mutations to the RAS protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform's therapeutic potential stems from its ability to enable the patient's immune system to identify and destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will give guidance for the future clinical development of this platform.

Targovax's development pipeline has three novel therapeutic candidates in clinical development covering six indications.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. Additionally, Targovax has other products in early stages of development.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.