Project

project

Translation of the Concept

To clinically translate the pioneering personalized immunotherapy approach a consortium of one Biotechnology Company and four academic partners with outstanding experience in immunotherapy, personalized treatment and RNA technology initiated the MERIT project.

Clinical Trial

The core of MERIT will be a European multi-center phase I/II clinical trial. Patients suffering from triple negative breast cancer, the most aggressive type of breast cancer, will be treated with a RNA based vaccine that is tailored to the individual genomic profile of each patient.

Research Program

The therapeutic trial will be accompanied by an extensive translational biomarker research program. Preclinical activities will be directed towards identification of compounds acting synergistically with the personalized vaccine and improved formulations.

The objective of work package 1 (WP 1; RNA Vaccine Production) is the manufacturing of GMP-grade  MERIT WAREHOUSE RNA and MERIT MUTANOME RNA for the clinical trial.

WP 2 will address the non-clinical studies and the regulatory affairs in order to implement a phase I/II clinical trial. The targeted screening for the presence of shared tumor antigens in a patient tumor as well as the screening process for genome–wide somatic tumor mutations will be set up in WP3 and performed accordingly during the clinical trial (WP4).

Biological activity of the MERIT vaccines will be monitored for each individual patient by an extensive biomarker and immunomonitoring program (WP5).
Knowledge generated in preclinical optimization studies (WP6) will enable a conception upgrade for upcoming clinical development.

WP7 will cover all project management activities.

Major Project Objective

The major project objective is to assess the clinical safety, feasibility and biological efficacy of a completely novel next-generation-sequencing-guided, individually-engineered and on-demand manufactured RNA vaccine approach to treat cancer.

Further goals of the MERIT project will be:

  • Develop a computational medicine platform to allow for rapid identification of immunogenic shared and mutated antigens in patients with triple-negative breast cancer (TNBC).
  • Set-up an RNA vaccine warehouse of shared tumor antigens addressing >95% of TNBC patients and a manufacturing process for timely on-demand manufacturing of a personalized RNA vaccine targeting multiple tumor-specific mutations.
  • Study associated biomarkers to identify molecular and immunological signatures that correlate with clinical events following treatment.
  • Identify synergistic compounds and optimized protocols of MERIT vaccines.

For a successful accomplishment of the MERIT project the consortium will implement a number of key innovations.

MERIT key innovations:

  • Key medical innovation: A next-generation sequencing guided, fully personalized therapeutic approach comprehensively exploiting the individual tumor antigen target repertoire.
  • Key technology innovation: An RNA vaccine platform that allows accelerated manufacturing and supply of individually tailored vaccines within a short time and at competitive costs.
  • Key process innovation: A fully integrated, quality-controlled, modular process that covers all steps from identification and validation of mutations and shared tumor antigens in clinical tumor specimen, algorithms for target prioritization, vaccine design, and vaccine production to clinical application involving a regulatory approval process required for the individualized approach.
  • Key management innovation: Accomplishment of a European fully personalized immunotherapy trial in triple negative breast cancer.
  • Key product innovation: Personalized RNA vaccines including pre-manufactured RNA warehouse vaccines and RNA mutanome vaccines that are produced on-demand. RNA-based immunostimulatory products for enhancement of immune responses.