Home
Cell and Gene Therapy
Cell and gene therapy utilizes immune cells from patients or healthy donors, which undergo ex vivo processing or genetic modification so that they can better recognize and destroy cancer cells. By harnessing the power of the immune system and genetic modification, these therapies can target cancer cells with greater precision, thereby reducing side effects and improving patient outcomes.
We are literally building the infrastructure of Oncode Accelerator for cell- and gene therapy product development.
Our team members have pioneered cellular therapies from the laboratory to the clinic and established preclinical and clinical European CAR T networks. We have unique expertise in CAR T design, manufacturing, valorization, treatment experience, and data structure.
Streamline cell-based Advanced Therapeutic Medicinal Product (ATMP) development through shared infrastructure and expertise.
Led by pioneers in the field of cell and gene therapy, the Workstream combines scientific experience with a multidisciplinary academic infrastructure, to build and optimize robust preclinical pipelines for ATMP development. Innovation Platforms (Patient Cohorts, Organoids and Artificial Intelligence) are integrated to optimize and develop prediction models for the success of ATMP production and clinical effects, with an aim to accelerate the process from target identification to proof-of-concept.
To facilitate rapid translation from the laboratory to the clinic a GMP simulator environment (GMP-sim) is constructed within the Workstream Cell and Gene Therapy. This GMP-sim creates a pre-GMP environment and consists of a core team of translational scientists and GMP production experts (including pharmacists) with specific focus on bridging the gap between preclinical research and GMP production of ATMPs for clinical application.
Bridge the gap from concept to clinic, with robust and innovative ATMP pipelines.
Shared infrastructure and strategic alliances
The infrastructure is shared with the Innovation Center for Advanced Therapies (ICAT), a part of the RegMed XB Pilot Factory. In addition, the BioTherapeutics Unit (BTU) from the Netherlands Cancer Institute is utilized as a second GMP-sim facility, forming part of the infrastructure of the Cell and Gene Therapy Workstream. By connecting and expanding GMP-sim infrastructures within the Netherlands, exploration of new production strategies and the quick transition from research-grade production to GMP conditions suitable for patient applications are enabled.
Oncode Accelerator has a strategic alliance with DARE‑NL: a unique partnership of all academic developers of ATMPs in the Netherlands. DARE-NL aims to accelerate the clinical implementation of ATMPs by providing a single knowledge and material exchange platform. Our Regulatory Innovation Workstream collaborates with DARE‑NL to integrate expertise in health technology assessment and regulatory science related to ATMPs. This ensures that new therapies are developed with a clear path to regulatory approval and patient access.
Co-develop ATMPs through Demonstrator Projects
Key to the success of the Oncode Accelerator program is the selection and execution of high-quality Demonstrator Projects which aim to both validate the Oncode Accelerator infrastructure while simultaneously addressing unmet medical needs. New partners who join the Oncode Accelerator Program with a Demonstrator Project to co-develop their cell-based ATMP asset, can tap into extensive scientific expertise and plug-and-play models for the development of oncological cell and gene therapies.
By combining the key capabilities of our Workstreams with the innovations from our Platforms we create a synergistic effect resulting in better therapies, tailored to individual patients or patient subgroups.
Watch the recording in our Building Bridges webinar series to learn more about the activities from the Cell and Gene Therapy Workstream.
Click on the arrows below to understand how Oncode Accelerator supports cancer researchers and drug developers in turning cell-based ATMP assets into de-risked clinical candidates through Demonstrator Projects.
-
Are you looking to...
- Co-develop cancer-specific ATMPs in collaboration with several centers of excellence:
- TIL (Netherlands Cancer Institute)
- TCR-T (Netherlands Cancer Institute, UMC Utrecht)
- Gamma-delta T cells (TEGs) (UMC Utrecht)
- CAR T (UMC Groningen, UMC Utrecht)
- Allogeneic stem cell-derived NK, CAR-NK, Tscm CAR-T (Radboud UMC)
- Extensively characterize the specificity and effectivity of the ATMP, including the on/off target reactivity profile
- Co-design the ATMP production process in collaboration with leading academic facilities
- Co-develop and validate QC tests for product characterization, safety and potency testing
- Execute engineering runs to assess GMP readiness and upscaling
- Establish a complete documentation set (e.g. protocols, batch record, IMPD, training records)
- Validate and evaluate (pre-)clinical readiness of your asset
- Get first-in-human proof of concept (POC) clinical data for your novel therapeutic leads
- Co-develop cancer-specific ATMPs in collaboration with several centers of excellence:
-
Would you like to utilize...
- Innovative technologies including viral and non-viral engineering, lentivirus and retrovirus manufacturing, and CRISR/Cas-9 gene editing technologies
- The extensive experience and multidisciplinary infrastructure (e.g. research, GMP production and clinical treatment) present in Dutch ATMP manufacturing centers
- Accelerate the GMP process scale-up using our GMP simulator infrastructure
- Existing infrastructure for GMP production and QC testing of ATMPs, specifically (gene-modified) cell therapy products
- Qualified vendors (vendors of raw materials, equipment, disposables) and cleared raw materials, equipment and disposables (including documentation)
-
Why should this be of interest?
In close collaboration with Demonstrator Project partners, exciting novel cell products are developed, manufactured, and (pre-)clinically tested.
By integrating organoid technology, well-defined patient cohorts data and materials and artificial intelligence (AI) from our Platforms through Demonstrator Projects, we optimize and develop prediction models for the success of ATMP production and clinical effects while aiming to de-risk the overall process.
Furthermore, utilizing datasets from Dutch and international registries (such as the EBMT CAR T-registry—which contains data from over 12,000 patients who have undergone CAR T-cell therapy—with fully anonymized real-life and clinical trial patient data), AI algorithms can be developed to predict the clinical benefits of cell therapy for specific patient subsets.
Patient Cohorts Organoids Artificial Intelligence
A Demonstrator Project can be executed at any stage of the Workstream pipeline and incorporates at least one of the innovative Platforms (Patient Cohorts, Organoids and/or Artificial Intelligence). The stages are designed to ensure that potential oncology therapies are thoroughly evaluated and de-risked before moving on to clinical trials. One stage of a pipeline will be one Demonstrator Project, eligible for up to 50% co-funding.
Contact us and learn more about how to join our program.
Oncode Accelerator is a dynamic collaboration of more than 35 public and private partners. The following consortium partners are part of the Cell and Gene Therapy Workstream.
Below is a curated selection of scientific publications by the Workstream Cell and Gene Therapy. Click on each publication to access the full text online.