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The trial is an open label, phase I/II trial of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. The trial consists of two cohorts: the main cohort of 19 patients and a second, modified cohort of 13 patients. The purpose of the modified cohort is to build on the positive findings from the main cohort in order to further optimize the TG01 treatment regimen and safety profile of the combination therapy. Although manageable, some allergic reactions were seen in patients in the main cohort when treating with TG01 and gemcitabine in parallel. Hence, the modified cohort received fewer TG01 injections overall than the main cohort, administered non-concomitantly with gemcitabine.
The modified cohort started recruitment in 2015 (link to PR), and the last patient enrolled has now been in the trial for one year. The one-year survival rate and safety data in the modified cohort showed that:
Magnus Jäderberg MD, Chief Medical Officer of Targovax, said, "We are delighted that we maintain a strong immune response and one-year survival rate with the reduced dosing regimen, essentially equivalent to and consistent with the previously reported data from the main cohort. This further strengthens the safety profile of TG01, and adds valuable understanding that will help us optimize the dosing regimen in resected pancreatic cancer patients, a condition which is notoriously difficult to treat. We look forward to see the two-year survival data for the modified cohort next year."
The data from the main cohort was presented here.
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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 as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS exclusively uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I studies 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, TG, is a target specific, neo-antigen therapeutic cancer vaccine platform that 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, Targovax has other products in early stages of development.
In March 2017 the Company listed its shares on Oslo Børs (Oslo Stock Exchange, main list).
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