Proof of concept study of sequential ONCOS-102 then pembrolizumab treatment in patients with advanced melanoma refractory to check-point inhibitors
Oslo 10 May 2017: Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, announces that the first patient has been recruited in the Company's ONCOS-102 study in advanced or unresectable melanoma patients who have had progression following checkpoint inhibitor.
The study is conducted at Memorial Sloan Kettering Cancer Center in New York.
Anne-Kirsti Aksnes, VP Clinical Development at Targovax said; "This study will allow us to assess in more detail the immune activating properties of ONCOS-102 already observed in earlier studies. The study also addresses a major medical need, as the majority of patients with advanced melanoma do not respond clinically to checkpoint inhibitors. Moreover, we are delighted to do this collaboration with one of the top cancer research centres in the world."
ONCOS C824 is an open label, Phase Ib combination study in 12 patients with advanced melanoma, whose disease has progressed despite prior treatment with pembrolizumab (Keytruda®, Merck &Co) or nivolumab (Opdivo®, Bristol Myers Squibb) and who will be sequentially administered ONCOS-102 followed by pembrolizumab. The primary objective of the study is to assess safety and immune activation at lesions and in peripheral blood. The secondary objective is to assess clinical response rate.
ONCOS-102, Targovax's lead drug candidate, is an engineered oncolytic adenovirus expressing granulocyte-macrophage colony stimulating factor (GM-CSF).
For further information, please contact:
Renate Birkeli, IR
Phone: +47 922 61 624
Media and IR enquires:
Jan Petter Stiff - Crux Advisers (Norway)
Phone: +47 995 13 891
Julia Phillips/Simon Conway - FTI Consulting (International)
Phone: +44 20 3727 1000
Arming the patient's immune system to fight cancer
Targovax 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, an emerging class of biological therapy. ONCOS exclusively uses an adenovirus that has been engineered to be an immune activator that selectively target cancer cells. In phase I it has shown to immune activate at lesional level which was associated with clinical benefit. We expect proof of concept data for this platform in 2017 from a clinical trial of lead product ONCOS-102 in patients with refractory malignant melanoma.
The second platform, TG peptides (TG), solely targets tumors that express mutated forms of the RAS protein. Mutations to this 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 a patient's immune system to identify and then 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, we have other products in early stages of development.
In July 2016, the Company listed its shares on Oslo Axess. In March 2017, the shares were upgraded to Oslo Børs, the main Oslo Stock Exchange.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.