Model OQR100/TYG100 -Active Checkpoint Control Immunotherapy (ACCI)

More than 1.100 patients have already participated in clinical trials to prove that G17 neutralization therapy to treat gastro-intestinal cancers especially pancreatic cancer, is efficacious with no serious adverse effects. Phase III*) clinical studies with G17DT (a therapeutic vaccine developed by Aphton Inc.), aiming at little gastrin neutralization, demonstrated survival benefit (P<0.003) with good quality of life in responding patients. However, G17DT clinical trial design populations were minimal and due to lack of active checkpoint control, G17DT, only had very low, between 45 and 75% immune-responder rates were seen- These were therefore statistically incomplete to justify regulatory approval. Despite that conditional registration was granted for G17DT in Canada and the EU, but Aphton Inc. was not able to make use of this achievement anymore. New studies in non-human primates with TYG100 show that the ACCI TYG100 is the by far superior successor of G17DT. TYG100 promises to achieve >100 fold higher anti-G17 IgG titers in almost 100% of the patients, thereby enabling an early regulatory approval pathway with a pivotal Phase II trial.*) An International Multicentre Randomized Controlled Trial of G17DT in Patients With PDAC”, Gilliam A.D. et al, Pancreas 2011 www.pancreasjournal.com Rapid induction (< 2 weeks) of clinically relevant IgG antibodies