NecstGen Delivers Consultancy to Advance Bone Regeneration Therapy

NecstGen Delivers Consultancy to Advance Bone Regeneration Therapy

Leiden, Netherlands — NecstGen, the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies, is proud to announce the successful completion of a consultancy project in collaboration with Dr. Debby Gawlitta from the Department of Oral and Maxillofacial Surgery & Special Dental Care at UMC Utrecht. The project focused on providing a technical and cost analysis of manufacturing options for Dr. Gawlitta’s innovative mesenchymal stromal cell (MSC)-derived spheroid therapy for bone defects.

Dr. Gawlitta’s research has demonstrated promising preclinical results in endochondral bone regeneration using MSC-derived spheroids. To bridge the gap between research and clinical application, this consultancy project assessed the feasibility and scalability of Good Manufacturing Practice (GMP) production for the therapy, offering insights into technical requirements, cost considerations, testing strategy, and potential pathways to clinical implementation.

Paul Bilars, CEO of NecstGen, highlighted the significance of the project:

“This consultancy project underscores our commitment to supporting innovators like Dr. Gawlitta in overcoming the technical challenges of advancing groundbreaking therapies. By offering tailored advice on manufacturing strategies, we aim to accelerate the translation of promising research into impactful patient treatments.”

Dr. Gawlitta expressed her appreciation for the collaboration:

“The consultancy provided by NecstGen has supported shaping the next steps for our therapy. Their expertise has clarified the technical and cost-related aspects of GMP manufacturing, enabling us to make informed decisions as we move toward clinical translation. With this foundation, we are better positioned to bring our bone regeneration therapy closer to reality.”

This project was supported by a RegMed XB/Dutch Cardiovascular Alliance Thematic Tech Transfer Voucher, which enabled the partnership and facilitated the evaluation of manufacturing options for this promising therapy.

About NecstGen
NecstGen is a non-profit CDMO and center of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility at the Leiden Bio Science Park, the largest bio-cluster in the Netherlands. NecstGen specialises in providing contract development, manufacturing, and consulting services to support academic and industrial therapy developers.

Pan Cancer T announces clinical development and manufacturing with NecstGen

Pan Cancer T announces clinical development and manufacturing with NecstGen

Pan Cancer T, a preclinical biotech focussing on the development of TCR-T cells, has extended its collaboration with Leiden ground NecstGen to include the clinical development and manufacturing of retroviral vectors. The parties have agreed to collaborate on the development of a retroviral vector manufacturing and testing process. The process will enable Pan Cancer T to utilise its licenced, stable producer technology to supply clinical vectors. NecstGen will develop a suitable, scalable manufacturing and testing procedure, establish a Master Cell Bank of the producer cell line, and be responsible for the clinical supply of viral vectors expressing the proprietary PCT-1 COSTIM TCR construct. The vector is to be used for TRC-T cell production in trials targeting Triple Negative Breast Cancer and Multiple Myeloma. This agreement follows an earlier agreement between Pan Cancer T and NecstGen, in which a commercially viable TCR-T cell production process was arranged.

Reinout Hesselink, VP of Process Development and CMC of Pan Cancer T says: We are very glad we have been able to extend our relationship with NecstGen to include the viral vector process. As both our vector- and our cell process are developed at the same CDMO, this agreement gives us the opportunity to develop a lean supply chain. This should speed up our clinical manufacturing capabilities.

The fact that we will be using a stable producer cell line, which allows for serum-free suspension culture, means that we will have a saleable, cost-efficient manufacturing process for one of our most critical materials.

Paul Bilars, CEO of NecstGen BV, adds that this agreement confirms our position as a go-to CDMO for cell and gene therapies. After assisting Pan Cancer T with their cell manufacturing process, we will now assist them with establishing their viral vector process.

This will be an interesting vector manufacturing process for us, and our technical capabilities as a CDMO, not only for cellular drug products but also for vector products, will be useful. We can run the process in our vector unit at different scales supporting preclinical, clinical and possibly commercial supply.

On Pan Cancer T

Pan Cancer T is an immunotherapy company developing next-generation TCR-T cell therapies for solid cancer.

The Company´s products are based on a form of T cell therapy called TCR-T therapy. It exploits the abilities of T cells to recognise and kill tumour cells. Pan Cancer T has developed a highly specific TCR targeted against Rophorin-1, which is highly expressed in tumour tissue of patients suffering from Triple Negative Breast Cancer and Multiple Myeloma. It has also developed a proprietary costimulatory molecule to enhance the activity and longevity of the TCR-expressing T cells.

Pan Cancer T´s differentiated Next Generation approach thus addresses two major obstacles in the field. Firstly, we work on a unique set of 30 untapped targets, exclusively and robustly expressed in multiple solid cancers. Secondly, our augmented T cells are engineered for enhanced durability in order to drive deeper and more durable clinical responses in multiple solid tumours.

On 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. NecstGen additionally offers cleanroom rental to allow organisations to maintain control of production while de-risking the capital investment required.

NecstGen is open to the world and supports academic, small, and large industrial therapy developers to translate research and early-stage clinical programs into patient treatments. One of NecstGen’s primary aims is to support the development of therapeutics for orphan diseases that may be underserved but are nevertheless catastrophic to people who suffer from them.

NecstGen is a mission-driven CDMO owned by Leiden University Medical Center (LUMC). This large-scale investment to support academia and industry was undertaken to address the barriers to entry for the creation of next-generation therapeutics, including:

  • Investment: The high cost of capital equipment, facilities, research, and development.
  • Limited capacity: Market availability of development and manufacturing slots.
  • Know-how: Knowledge, expertise, and talent acquisition.
  • Intellectual property: Complex ownership and control of the technologies required to realise new therapies successfully.
OogFarma Partners with NecstGen for Ophthalmic Therapy.

OogFarma Partners with NecstGen for Ophthalmic Therapy.

Leiden, the Netherlands, October 8, 2024 – OogFarma has entered into a strategic partnership with NecstGen, a non-profit Contract Development and Manufacturing Organisation (CDMO), to rent cleanroom facilities to support its distribution of Ophthalmic Therapies utilising its innovative syringe system. This partnership focuses on making essential treatments for macular degeneration more affordable, thereby reflecting the shared mission of both organisations.

OogFarma’s simple mission is to deliver high quality ready-to-use anti-VEGF treatment as safely and efficiently as possible, directly to healthcare professionals. Their pre-filled syringes are designed to eliminate waste and unused- or ‘residual’- volume. This makes for a cost-effective solution, that also eliminates the need for preparations steps at point of care, potentially improving patient safety.

The pre-filled syringe is particularly effective for administering small doses, which, in this case, is anti-VEGF treatment essential for patients with macular degeneration, an eye disease.

NecstGen’s advanced GMP-compliant Grade B cleanrooms and facilities provide OogFarma with the end-to-end processing environment it requires. Training and support activities will be provided by NecstGen’s team, and these are shaped by the requirements and feedback of OogFarma. This collaboration is about more than cleanroom rental; it is about creating a shared solution to deliver affordable therapies.

“We had an idea of what we wanted to create—requiring the right facility, quality systems, logistics, inhouse QC, and good documentation practices,” said Bart-Jan Thies, CEO of OogFarma. “NecstGen offered a true plug-and-play solution, like a GMP-train ready to board, providing everything we needed, including essential training. We are particularly pleased with NecstGen’s state-of-the-art facility, which is qualified and validated to meet the latest standards, ensuring a seamless process.”

In the partnership, the syringes are used for ophthalmic treatments; however, future potential uses may include Gene Therapy, which is commonly used to deal with small-volume, costly goods. OogFarma and NecstGen are committed to reducing the barriers to advanced treatments, making a difference for patients who need them the most.

“At NecstGen, our mission is to support those making treatments accessible and affordable,” said Paul Bilars, CEO of NecstGen. “Our partnership with OogFarma helps to address the challenging cost of goods in healthcare, ensuring that an innovative solution can be utilised to better serve the patients who need treatments. By enabling technologies like this syringe, we aim to help create a future where advanced, quality healthcare is accessible to all.”


About OogFarma

OogFarma is a new, innovative compounding pharmacy that focuses entirely on ophthalmology.

With the increasing demand for ophthalmic injections, we provide a solution that guarantees quality, safety, and efficiency. We are proud to support the Dutch market with the latest scientific insights and innovative products. By exclusively focusing on ophthalmic treatments, we aim to deliver the best care to both ophthalmic specialists and their patients.

“Ophthalmic injections are our specialization. Patient safety and quality are our foundation.”


About NecstGen

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

NecstGen offers:

  • Full contract manufacturing services for Cell Therapy and Viral Vector development and manufacturing
  • Process design, scale-up, optimisation, and automation for Cell Therapy and Viral Vector
  • Assay development for in-process, release, and potency testing
  • Cleanroom rental, including services for QA, QC, and QP.
€10 Million Awarded to NecstGen, NTrans Technologies, LUMC, and Divvly to Transform Cell and Gene Therapies

€10 Million Awarded to NecstGen, NTrans Technologies, LUMC, and Divvly to Transform Cell and Gene Therapies

• A grant from IPCEI Med4Health will facilitate the development of advanced technologies to improve cell and gene therapy production.

• The consortium will focus on novel technologies and production processes to overcome current bottlenecks in cell and gene therapy manufacturing, enabling cost-effective production and facilitating clinical trials for conditions like Duchenne Muscular Dystrophy and Diamond Blackfan Anemia.

Leiden, the Netherlands, August 28, 2024 – In a major advancement toward bringing cell and gene therapies more rapidly to patients, NecstGen, together with partners NTrans Technologies, Leiden University Medical Center (LUMC), and Divvly, has been awarded a €10 million grant from the European Union’s Important Project of Common European Interest (IPCEI) Med4Cure program. This project aims to transform the treatment landscape for serious medical conditions like Duchenne Muscular Dystrophy and Diamond Blackfan Anemia by pioneering cost-effective production methods, making these treatments more accessible.

Addressing Major Industry Challenges

Cell and gene therapies offer the potential to treat, prevent, and cure devastating diseases by targeting the underlying genetic causes. Yet, their development is often hindered by high costs and complex manufacturing processes, largely due to limited access to advanced production methods. This restricts therapy developers and manufacturers from scaling up production effectively. This project aims to break down these barriers, enhancing the scalability and affordability of therapies and ensuring that they reach patients quicker.

Collaborative Efforts and Impact

NecstGen, a non-profit contract development and manufacturing organization (CDMO), will lead the project, leveraging its comprehensive approach to implementing a complete value chain, from concept to patient. It will focus on innovative cell line and production process technologies to reduce overall production costs. NTrans Technologies will improve treatment effectivenes s through its proprietary gene-editing platform, while Divvly will enhance industry compliance for Good Manufacturing Practices (GMP) with its advanced software solutions. The LUMC, a renowned Dutch medical university, will lead (pre-)clinical trials, offering crucial insights and support, directly impacting therapy development for Duchenne Muscular Dystrophy and Diamond Blackfan Anemia.

“By uniting our strengths and challenging current paradigms in cell and gene therapy manufacturing, we can accelerate the availability of these life-saving therapies,” said Paul Bilars, Chief Executive Officer, NecstGen. “At NecstGen, we are dedicated to transforming these technologies to support therapy developers and ultimately, deliver life-changing treatments to patients, both in Europe and globally.”

About IPCEI
The Important Project of Common European Interest (IPCEI) is an initiative by the European Union designed to support large-scale, cross-border projects that are highly innovative and strategically important for Europe. With 14 highly innovative projects, the IPCEI Med4Cure program aims to enhance drug discovery and pharmaceutical production processes, addressing major health challenges and fostering innovation and collaboration across Europe.

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

NecstGen offers:

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

For more information about our project, please visit our website or contact us directly. If you are a therapy developer or industry professional interested in partnering with us or learning about our innovative solutions, please reach out to:
https://necstgen.com/contact-us/

For media inquiries, please contact:
bd@necstgen.com

This project has received funding from Rijksdienst voor Ondernemend Nederland (Netherlands Enterprise Agency).

Press Release: NecstGen Recurring Customer Pan Cancer T Secures € 4.25 Million Seed Extension

Press Release: NecstGen Recurring Customer Pan Cancer T Secures € 4.25 Million Seed Extension

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

Collaboration UMC Utrecht for Bone Regeneration Therapy

Collaboration UMC Utrecht for Bone Regeneration Therapy

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.

NecstGen Services

Cell Therapy Development & Manufacturing

Viral Vector Development & Manufacturing

Cleanroom Rental

About Us

NecstGen is a non-profit CDMO and Centre of Excellence for Cell and Gene Therapy located in a purpose-built GMP facility in Leiden, The Netherlands. Dedicated to the field of Cell and Gene Therapies, we provide expertise and capacity.

NecstGen

Team

Partners

History

Facility

Ecosystem