Phase 1 clinical trial evaluating a neoantigen-targeted dendritic cell vaccine (Neo-mDC) in lung cancer patients

We are excited to share the publication by Ingels J., De Cock L.,et al.in Cell Reports Medicine, reporting the results of a phase 1 clinical trial evaluating a neoantigen-targeted dendritic cell vaccine (Neo-mDC) in lung cancer patients. CellGenTherapies had a pivotal role in advancing this highly personalized cancer vaccine to its first-in-human clinical trial.

Neo-mDC vaccine is an advanced therapy medicinal product (ATMP) consisting of autologous dendritic cells (DCs) loaded with personalized messenger (m)RNA encoding patient-individual neoantigens. The mRNA-loaded DC vaccine, the neoantigen identification bioinformatic pipeline, and the immunomonitoring were developed by the groups of prof. Karim Vermaelen, prof Bjorn Menten and prof Bart Vandekerckhove at Ghent University. CellGENTherapies translated this vaccine format into a GMP-compliant product, obtained a manufacturing license, and produced the personalized mRNA and DC batches for this phase I clinical trial.

“Seeing for the first time dendritic cell injections in patients evoke strong and durable immune responses against lung cancer targets was amazing. This study is a milestone and the result of years of dedicated efforts, overcoming logistical challenges with the collaboration of outstanding research teams and numerous clinical departments at Ghent University Hospital. Importantly, this study demonstrates our center’s ability to swiftly transition concepts from the lab to studies in patients. The extensive experience and data gathered from this study pave the way for developing even more powerful cell therapies in our center, reinforcing Ghent as a major hub for cell and gene therapies in the region and beyond.”

Prof Karim Vermaelen, Head of Clinics Pulmonary Medicine Department UZ Gent, Prof. dr. Karim Vermaelen | UZ Gent, prof. Karim Vermaelen (MD, PhD) | CRIG

“Obtaining the manufacturing license and the timely production of the personalized Neo-mDC batches for this phase I clinical trial illustrate the commitment and dedication of our team. These accomplishments underscore the potential of CellGENTherapies in translating cell and gene therapies developed by researchers into phase 1 clinical trials, and to produce the requested personalized batches during the recruitment phase”.

Prof Bart Vandekerckhove, Dir CellGENTherapies  prof. Bart Vandekerckhove (MD, PhD) | CRIG; Research Explorer – Researcher profile for Bart Vandekerckhove

Key highlights of the publication

The phase 1 clinical trial was designed to evaluate the safety, feasibility and immunogenicity of Neo-mDC vaccination in resected non-small cell lung cancer (NSCLC) patients. The process to obtain this personalized vaccine, starting from the identification of neoantigens in the patient’s tumor to the design and production of the customized vaccine, took place entirely at the University Hospital of Ghent (UZGent), with CellGenTherapies being involved in the manufacturing of Neo-mDC vaccine batches according to GMP standards. The clinical trial showed that Neo-mDC vaccination is safe, feasible and can induce robust, long-lasting T cell responses that were very similar to responses elicited by known potent vaccines such as measles vaccines. This clinical trial lays the foundation for further clinical development of Neo-mDC vaccine.

The publication can be accessed here: https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(24)00185-X.