Rotterdam and Leiden, Netherlands, July 17, 2024 – NecstGen, a non-profit CDMO, and Pan Cancer T, a company developing a TCR-T cell product (PCT1:CO-STIM) for the treatment of triple negative breast cancer, announce further projects.

This new agreement with Pan Cancer T builds directly on the solid foundation established in previous collaborations between both organisations. Following a successful technology transfer and proof-of-concept scale-up, both parties are happy to announce that more activities will be performed by NecstGen at its state-of-the-art facility for Cell and Gene Therapy development and manufacturing located in Leiden.

Rachel Abbott, CEO, Pan Cancer T commented, “Successfully completing our latest funding round will accelerate our path to the clinic and treating patients. CMC development is a critical component to realising this ambition. We recognise in NecstGen a partner committed to reducing the costs of development and manufacturing whilst maintaining commitment to quality.”

The companies will continue to undertake the process and analytical development of Pan Cancer T’s novel Cell Therapy. Led by Melissa van Pel, Head of Cell Therapy, NecstGen will utilise its large equipment portfolio and expert team to progress the process and assays required for PCT1:CO-STIM to be successfully manufactured.

This continued collaboration demonstrates NecstGen’s capability to scale and enhance processes as its partnerships evolve to enable bridging early research and clinical applications, including GMP manufacturing. 

Paul Bilars, CEO, NecstGen, said, “I am delighted with my team’s performance in our partnership with Pan Cancer T to date, demonstrating what NecstGen can contribute to organisations in Cell and Gene Therapy. NecstGen now routinely receives feedback that we are offering partners a competitive cost basis. This is core to our vision as an organisation. Maximising the budget of all organisations involved in Cell and Gene Therapy will accelerate therapies reaching patients and benefiting society.”

About Pan Cancer T

Pan Cancer T was founded in late 2020 as a spin-off from Erasmus MC (Rotterdam, the Netherlands) to advance next generation TCR T cell therapies for hard-to-treat solid tumors. The Company’s approach includes two differentiating elements. First, it exploits unique targets for T cells that are exclusively and robustly expressed by multiple solid cancers. Second, it develops technologies that enhance the durability of the T cells. The Company has ongoing R&D programs to develop safe and effective adoptive T cell therapies amenable to large cohorts of patients with triple negative breast cancer as well as cancers of the bladder, ovarium, colorectum, prostate, skin, esophagus, lung, or brain. For more information, please visit: www.pancancer-t.com

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing and rental services to academic and small/large industrial therapy developers to deliver a new generation of therapies to patients. For more information visit www.necstgen.com.

For more information please contact:

Pan Cancer T

Marconistraat 16
3029 AK, Rotterdam
The Netherlands

Dr. Rachel Abbott
CEO

E: rachel.abbott@pancancer-t.com

NecstGen

Sylviusweg 62
2333 BE Leiden
The Netherlands

Tristan Pritchard-Meaker, PhD
Head of Business Development

E: tristan@necstgen.com

Leiden, Netherlands — NecstGen, the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies, is proud to announce a collaboration with Dr. Debby Gawlitta of the Department of Oral and Maxillofacial Surgery & Special Dental Care at UMC Utrecht. This collaboration aims to develop a pioneering therapy for bone defects, leveraging the power of mesenchymal stromal cell (MSC)-derived spheroids.

Dr. Gawlitta’s research has demonstrated promising results in preclinical studies, showcasing successful endochondral bone regeneration in rat and goat models. These findings show the potential of devitalised bone marrow-derived MSC-spheroids in treating bone defects, a significant advancement in regenerative medicine.

Through this collaboration, NecstGen will support Dr. Gawlitta’s project by offering development support of this innovative therapy.

“We are excited about the potential of this collaboration with Dr. Gawlitta,” said Paul Bilars, CEO of NecstGen. “Our mission is to accelerate the delivery of innovative medicinal products to patients. This project exemplifies our commitment to support the next generation of therapies that can significantly impact patients’ lives.”

The project focuses on the GMP manufacturing of human MSC-derived spheroids, targeting maxillofacial and spinal fusion defects. It encompasses an extensive process, including expanding MSCs, spheroid formation, and rigorous quality control assays to ensure the required safety and efficacy standards.

This collaboration marks a significant step forward in bone regeneration therapy and reinforces the importance of partnerships between academia and industry in advancing healthcare innovations.

Dr. Gawlitta has received a RegMed XB/Dutch Cardiovascular Alliance Thematic Tech Transfer Voucher sponsoring this collaborative activity to further develop her innovative findings into treatments. “This subsidy of RegMed XB/DCA for propelling advanced therapies to clinical implementation is coming at the right time to explore and take our next steps in the translational axis. The expertise and experience of NecstGen in this field is instrumental in designing our envisaged bone regenerative treatments.”

For more information about NecstGen, please visit necstgen.com.

About NecstGen

NecstGen is a non-profit CDMO and centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. NecstGen provides critical contract development, manufacturing and rental services to academic and industrial therapy developers to deliver a new generation of therapies to patients.

About RegMed XB/Dutch CardioVascular Alliance TTT Voucher

The Thematic Tech Transfer (TTT) vouchers from RegMed XB/Dutch CardioVascular Alliance support the valorization trajectory of promising academic research within the regenerative and/or cardiovascular medicine fields. For more information, please visit www.tttransfer.nl and contact our impact officers.

European Innovation Council Awards €2.5 Million Grant to Trince, NecstGen, and IBSAL for Advancing Cell Therapy Manufacturing

[Ghent, Leiden, Salamanca, 15/03/2024] – Following a rigorous selection process by an expert panel, Trince, NecstGen, and IBSAL are proud to announce that their “Penphomet” project has been selected by The European Innovation Council (EIC) for a significant grant of €2.5 million. Out of 257 eligible submissions, Penphomet is one of the 27 that has been awarded. Led by Trince, the consortium aims to revolutionize cell therapy manufacturing by integrating nanotechnology, optics, and microfluidics.

Cell therapy has shown promising results in cancer treatment, specifically using patient-derived cells like T cells and mesenchymal stromal cells (MSCs) that have been genetically engineered to effectively target cancer cells.

The primary focus of the Penphomet project is to develop a safer, non-viral method for cell engineering that minimally impacts cell functionality and phenotype. The aim is to significantly reduce the costs associated with cell therapy manufacturing.

Over three years, the project aims to deliver a fully automated, high-throughput system that can be installed in centralized cell production facilities or integrated into point-of-care cell manufacturing equipment.

“We are grateful for the EIC’s support in funding the Penphomet project. It demonstrates that our breakthrough technology is addressing a crucial gap in the field of cell therapy,” said Philip Mathuis, CEO at Trince. “Together with our partners NecstGen and IBSAL, we are committed to advancing cell therapy manufacturing, ultimately benefiting patients and healthcare systems.”

“NecstGen is proud to be a part of the Penphomet consortium supporting the further development of the innovative technology of Trince. Non-viral methods for cell engineering represent a potentially cost saving route for cell engineered therapies. And furthering their use is important for the field of Cell and Gene Therapy and mission of NecstGen to enable patient access” said Paul Bilars, CEO, NecstGen.

“For the IBSAL and its main partners, the University Hospital and the University of Salamanca, the Penphomet project opens the possibility of exploring a new strategy of cell modification that can be enormously attractive for the next generation of advanced therapy medical products, and we are really pleased to be part of this initiative,” says Prof. Fermin Sanchez-Guijo, principal investigator of the IBSAL in this project.

The Penphomet project represents a significant advancement in improving the accessibility and affordability of cell therapies, with the potential for far-reaching impacts on cancer treatment and beyond.

For media inquiries or further information, please contact:

[Philip Mathuis]

[Trince]

[+32 9 273 56 25]

[info@trincebio.com]

Trince

Trince offers a unique intracellular delivery (transfection) technology for the life sciences/biotech field. The LumiPore platform is based on the interaction between pulsed laser light and photothermal nanomaterial. By irradiating the proprietary nanoparticles with laser light, highly localized light-induced thermal and mechanical forces are generated. When these forces come into contact with the cell membrane, they create temporary pores through which external effector molecules can enter the cell. This ‘photoporation’ technology was developed as a next-generation intracellular delivery platform for efficient, flexible gentle, and safe delivery of a wide variety of effector molecules in a broad range of primary and hard-to-transfect cells, while maintaining high therapeutic quality. The technology can deliver a diverse set of payloads in various hard-to-transfect cell types, including suspension and adherent cells (directly in a standard lab recipient) and even living tissue slices.

NecstGen

NecstGen is a non-profit CDMO and centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park.  NecstGen provides critical contract development, manufacturing and rental services to academic and industrial therapy developers to deliver a new generation of therapies to patients.

NecstGen offers:

• Full contract manufacturing services for Cell Therapy and Viral Vector
• Process design, scale-up, optimisation and automation for Cell Therapy and Viral Vector
• Assay development for in-process, release, and potency
• Cleanroom rental including services for QA, QC, and QP.

IBSAL

The Institute of Biomedical Research of Salamanca (IBSAL) is part of IECSCYL (The Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León) and is one of the Biomedical Research Institutes accredited by the Carlos III Institute from the Spanish Ministry of Health (Order of February 17, 2014). IBSAL’s mission is to develop clinical and translational research, promoting synergy between clinical and basic research groups and optimizing resources through shared services and efficient management structures. One of the 6 areas of the Institute is Gene, Cell and Transplant Therapy, coordinated by Prof. Sánchez-Guijo. The location where the project tasks will be carried out is the Hematology Department of the University Hospital of Salamanca (HUS), also chaired by Prof Sanchez-Guijo. The Department provides services a.o. in cell therapy, includes a GMP Facility and a Translational Research Lab, and has extensive experience in the preclinical and clinical development and management of ATMPs, especially MSCs but also CAR T cells. 

EIC Transition projects focus on results generated by EIC Pathfinder, FET (Future and Emerging Technologies – as the predecessor of EIC Pathfinder)  or European Research Council (ERC) Proof of Concept projects, to mature the technologies and build a business case for specific applications. Grants of up to €2.5 million are available to validate and demonstrate technology in application-relevant environment and develop market readiness. 

Leiden November 16^th, 2023 — NecstGen, Netherlands, a pioneering biotechnology center and non-profit CDMO specialising in Gene and Cell therapy, is proud to announce its groundbreaking collaboration with the Center for Gene and Cellular Therapy at Aarhus University Hospital (AUH), Denmark. This partnership aims to advance the production of mesenchymal stromal cells (MSCs) for experimental clinical use, ushering in a new era of advanced therapies and medical breakthroughs.

Mesenchymal stromal cells hold immense promise for regenerative medicine due to their remarkable ability to regenerate damaged tissue and regulate the immune system. However, their large-scale production while complying with strict Good Manufacturing Practice (GMP) standards has remained a challenge. NecstGen and AUH’s Center for Gene and Cellular Therapy are joining forces to address this challenge by introducing bioreactor-driven GMP-compliant MSC production processes.

Key Highlights of the Collaboration:

• Advanced Bioreactor Use: Utilizing advanced bioreactors, the partnership will enhance MSC production, ensuring large-scale availability for clinical trials.
• Strict GMP Adherence: Commitment to GMP standards guarantees the highest quality of MSCs, crucial for clinical use and future therapy commercialization.
• Faster Clinical Trials: The initiative aims to fast-track the development of therapies for conditions like degenerative diseases and immune disorders through efficient MSC production.
• Global Patient Impact: The collaboration is poised to make a substantial contribution to regenerative medicine, offering new treatment avenues for patients worldwide.
• Scientific Excellence: Both entities are united in their pursuit of excellence, with a common goal to revolutionize healthcare through innovative cell therapies.

Dr. Melissa van Pel, Head of Cell Therapy at NecstGen, expressed her excitement about the collaboration, stating, “This partnership marks a significant milestone in the field of regenerative medicine. By combining our expertise with AUH’s Center for Gene and Cellular Therapy, we are poised to make substantial advancements in the production and clinical application of mesenchymal stromal cells.”

Dr. Bjarne K. Møller, Director of AUH’s Center for Gene and Cellular Therapy, added, “Our shared commitment to GMP compliance and rigorous scientific standards ensures that the MSCs produced through this collaboration will meet the highest quality and safety requirements. We are excited about the potential of this research to benefit patients in the near future.”

The collaboration between NecstGen, NL, and AUH’s Center for Gene and Cellular Therapy represents a leap forward in the field of regenerative medicine. Together, they aim to drive innovation, accelerate clinical development, and ultimately provide new hope for patients seeking advanced treatments for challenging medical conditions.

For media inquiries, please contact:

Tristan Pritchard-Meaker

Head of Business Development

NecstGen

Email: tristan@necstgen.com

Phone: +31 6253 44 672

About NecstGen:

The Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) comprises a state-of-the-art facility for development and GMP manufacturing of Cell and Gene Therapies. NecstGen additionally offers cleanroom rental, Quality Control services and a Qualified Person to allow organisations to maintain control of production while de-risking the capital investment required to do so.

Website: https://necstgen.com

About Aarhus University Hospital’s Center for Gene and Cellular Therapy:

The Center for Gene and Cellular Therapy at Aarhus University Hospital is dedicated to advancing the field of regenerative medicine through research, development, and clinical applications. Its mission is to bring cutting-edge therapies to patients with unmet medical needs.

LinkedIn: https://www.linkedin.com/posts/center-for-gene-and-cellular-therapy-aarhus-university-hospital_celltherapy-genetherapy-cgctauh-activity-7018188460528136192-zHhs/?trk=public_profile_like_view

Leiden, Netherlands, September 19, 2023 – Necstgen, a CDMO and centre of excellence for Cell and Gene Therapy, and ProteoNic, a leading provider of premium vector technology and services for efficient production of biologics, announce the successful development of improved lentiviral (LV) vectors, driving higher titers of functional viral particles based on the application of ProteoNic’s 2G UNic™ premium vector technology.

Both companies, located on the Leiden Bio Science Park, recognise the need to increase viral titres and optimise production processes. Cost-efficiency and manufacturing yields play a critical role in the feasibility of vector-based therapies. Through their combined efforts ProteoNic and NecstGen have achieved up to 5-fold higher functional LV titers, with significant potential impact on overall process efficiency.

Frank Pieper, CEO of ProteoNic commented “We are excited to see our collaboration with Necstgen achieving this important milestone. We will continue our efforts aimed at improving AAV and LV vectors, catering to both transient production systems and  stable viral producer cell lines”.

Paul Bilars CEO, NecstGen said “These significant results show the strength and importance of our local ecosystem, and highlight how collectively we can address the challenges of Cell and Gene Therapy development and their translation to solutions for patients and society”.

Through their combined efforts ProteoNic and NecstGen aim to improve and advance AAV and LV viral vector manufacturing technology and increase production capacity as well as payload expression in target tissues, to the ultimate benefit of patients in need of Cell and Gene Therapies.

The companies aim to make the improved technology broadly accessible. ProteoNic will offer licensing and co-development opportunities, while NecstGen plans to apply the technology in its CDMO business.

About ProteoNic

ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines and viral vectors with greatly improved production characteristics. The company commercializes its proprietary 2G UNic™ technology through licensing and partnership arrangements. For more information, see www.proteonic.nl.

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing and rental services to academic and small/large industrial therapy developers to deliver a new generation of therapies to patients. For more information visit www.necstgen.com.

For more information please contact:

ProteoNic

Mark Posno, PhD

Vice President Business Development

T: +1 617 480 8016

E: posno@proteonic.nl

NecstGen

Tristan Pritchard-Meaker, PhD

Head of Business Development

E: tristan@necstgen.com

Mölndal, Sweden and Leiden, Netherlands, May 16, 2023 – Cline Scientific, a Swedish life science company developing a novel regenerative medicine, and NecstGen, a CDMO and centre of excellence for Cell and Gene Therapy, have signed a Letter of Intent to develop and manufacture clinical batches of Cline’s cell therapy for cartilage repair, StemCART.

Through this intended partnership, NecstGen will support the further development and manufacture of Cline’s cell therapy for damaged cartilage, StemCART. StemCART is an Advanced Therapy Medicinal Product (ATMP) that aims to revolutionize the treatment of cartilage damage for patients worldwide. The Swedish therapy developer envisions to out-license StemCART to a commercial partner following successful in-human trial results.

Hanne Evenbratt, CEO of Cline Scientific: “This LOI is an important first step in Cline’s preparation for the clinical phases of StemCART and a principal component of the manufacturing strategy. We are very excited to move forward with the team at NecstGen and anticipate a prosperous collaboration.”

Paul Bilars, CEO of NecstGen: “We are happy to support Cline Scientific throughout this critical phase in the development of its StemCART therapy. This potential joint action is very much a demonstration of our mission to support organizations developing therapies for patients”

About Cline Scientific
Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. Cline’s unique patented surface nanotechnology provides solutions to critical challenges for cell-based products and processes in Life Science. Cline is driving two projects through to a clinical-stage, StemCART – a stem cell therapy for joint repair, and CellRACE- a cancer diagnostic to predict metastasis.

About NecstGen
NecstGen is a centre of excellence for Cell and Gene Therapy, located in a large 4000m2 purpose-built GMP facility on the biggest bio-cluster in the Netherlands, Leiden Bio Science Park. NecstGen provides critical contract development, manufacturing and rental services to all therapy developers who aim to deliver the next generation of treatments to patients. For more information visit www.necstgen.com.

Cline Scientific
Hanne Evenbratt, CEO. T: +46 0704887923 E: hanne.evenbratt@clinescientific.com

NecstGen
Tristan Pritchard-Meaker, Head of Business Development E: tristan@necstgen.com