Immunetune is proud to announce that they can continue their regulatory pathway, following supportive Scientific Advice from the Paul-Ehrlich Institute (PEI) in Germany on the 18th of June 2020.
“The overall positive feedback received from the renowned Paul-Ehrlich Institute strengthens Immunetune’s ambitions and path forward to enter clinical testing”, said Dr. Gerben Zondag, CEO and founder of Immunetune. “We are continuing as planned to advance our clinical development program to provide novel, tumor-specific treatment options to cancer patients.”
The available pre-clinical package (including planned confirmatory experiments and final toxicology study), the CMC / GMP production process as well as the clinical protocol for its synthetic DNA-based cancer vaccines have been thoroughly assessed by PEI experts, and (minor) suggestions and recommendations will be taking into account accordingly.
Immunetune intends to enter the clinic early 2021 with a two-stage phase IIa study in patients with solid tumors to assess the safety and immunogenicity of its synthetic DNA vaccines alone or in combination with checkpoint inhibitors.
