LIÈGE, BELGIUM & GRENOBLE, FRANCE--PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancer, announces today the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia. This is the result of a call for proposals on R&D projects in the field of Advanced Therapy Medicinal Products (ATMP). Members of the project consortium will receive €8.1M ($8.9M) in funding, including €4.7M ($5.1M) for PDC*line Pharma. The total budget is €12.5M ($13.7M).

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The project aims to develop PDC*neo+, a personalized therapeutic vaccine for colorectal cancer using PDC*line Pharma's innovative PDC*line technology. Targeting unique neoantigens in each colorectal cancer patient, PDC*neo+ represents a groundbreaking approach in cancer immunotherapy.

Globally, colorectal cancer (CRC) is among the most prevalent and deadly cancers, with a high recurrence rate post-surgery and chemotherapy. PDC*neo+ is designed as an adjuvant treatment to prevent relapses in high-risk patients with stages II, III and certain stage IV CRCs. Its action post-chemotherapy potentially makes it a pioneering treatment in CRC.

This project is a collaborative effort involving several key partners. OncoDNA contributes its expertise in personalized medicine and liquid biopsies, focusing on neoantigen identification and circulating tumor DNA analysis. salamanderU is developing a compact isolator for decentralized vaccine production to bring manufacturing closer to the clinical centers. Academic centers UCLouvain - IREC (Institut de Recherche Expérimentale et Clinique)/MIRO (Molecular Imaging, Radiotherapy and Oncology) and ULB-BCTL (Breast Cancer Translational Research Laboratory) offer essential support in translational research and clinical trial execution.

The main goal of the project is to confirm the clinical feasibility and safety of PDC*neo+ in a phase I trial. This initiative is expected to have a significant impact on CRC patient care, alongside broader economic and societal benefits. Over its three-year duration, across all partners, it is estimated to create or maintain around 34 full-time jobs.

“We are very happy that our project has been selected by the Walloon region. The subsidies and collaborative effort of the partners in the consortium will speed-up the launch of a first phase I clinical trial with PDC*neo+, the personalized vaccine based on PDC*line cells loaded with neoantigens to treat CRC patients, positioning our technology in the very promising field of neoantigen-based cancer vaccines,” said Eric Halioua, CEO of PDC*line Pharma.

“We are very thrilled to be part of this innovative project and clinical trial. It acknowledges our recent proficiency in the discovery of neoantigens and our robust experience in liquid biopsy monitoring by detection of circulating tumor DNA (ctDNA)," said Jean-Pol Detiffe, founder and chief strategy and innovation officer at OncoDNA.

“We are very enthusiastic about participating in this collaborative project and bringing the production of PDC*Neo+ closer to the patient. Through this project, salamanderU strengthens its position as a designer and manufacturer of innovative isolators for the manufacture of ATMP,” said Claude Dedry, CEO of salamanderU.

“We are very pleased and motivated to take part in this exciting and collaborative project. With our expertise, we will contribute to characterizing the immunogenicity of colorectal cancers and to the development and recruitment of patients for this clinical trial,” said Marc Van den Eynde and Jean-Pascal Machiels, oncologists at UCLouvain (Cliniques universitaires St-Luc).

“We are delighted to be involved in this interesting collaborative project. Leveraging our expertise in various ‘omics’ technologies, such as single-cell RNA sequencing and spatial transcriptomics, we will delve into the tumor microenvironment of colorectal cancers. Our objective is to develop predictive biomarkers for vaccine response and actively contribute to patient recruitment for the clinical trial," said Christos Sotiriou, head of the BCTL at ULB and Francesco Sclafani, gastrointestinal oncologist and clinical researcher at Institut Jules Bordet, Hopital Universitaire de Bruxelles (HUB) and Bordet Cancer Research Laboratory.