OncoQR ML has achieved in vivo proof-of-concept (PoC) for its two prototype and lead product candidates directed against two major oncology targets: OQR100 (G17/little gastrin) for gastro-intestinal cancers and OQR200 (HER2/neu) for breast cancer.
Lead candidate TYG100 (formerly OQR100, out-licensed to TYG oncology Ltd.) is an “Active Checkpoint Control Immunotherapy (ACCI)” for the treatment of gastroenterological cancers such as pancreatic, stomach, colon, and gastro-esophageal cancer. The immunogen of TYG100 contains a small part of G17 (little gastrin).
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
Lead candidate OQR200 is a new candidate against HER2/neu, the by far best characterized and clinically validated target to treat breast cancer indications. A reversible induction of HER2/neu specific antibodies has been demonstrated. In vitro, the immune response induced by OQR200 has been shown to have superior efficacy in a direct side by side comparison with successful clinical products (Herceptin/Perjeta). OQR200 induced strong T cell immunity against Her2/neu expressing autologous targets cells in non human primates but also in Balb/c mice.
- OQR300: to a 3rd blockbuster-clinically validated target (not disclosed)
- OQR400: to a 4th blockbuster-clinically validated target (not disclosed)