1 The EIC Accelerator Project

EIC Accelerator Program: An In-Depth Overview

The EIC Accelerator program, part of the European Innovation Council (EIC), plays a pivotal role in nurturing innovative startups and small-to-medium enterprises (SMEs) in Europe, particularly in the DeepTech sector. This program is designed to support high-risk, high-potential companies that are developing groundbreaking technologies and solutions.

Funding Structure

The EIC Accelerator offers a dual funding mechanism comprising grants and equity investments, aimed at facilitating the growth and scaling of innovative businesses:

Purpose and Impact on the European Ecosystem

The primary purpose of the EIC Accelerator is to empower innovative startups and SMEs, enabling them to thrive in the competitive global market. By providing substantial financial support, the program helps overcome common barriers faced by early-stage companies, such as limited access to capital and resources. Furthermore, the EIC Accelerator plays a significant role in fostering collaboration between startups and private investors, thereby enhancing the overall innovation landscape in Europe. By facilitating connections with venture capitalists and industry leaders, the program increases the chances of securing additional funding and strategic partnerships.

Case Study: Genewity B.V. and the i-THYMUS Project

Company Overview: Genewity B.V., based in the Netherlands, is a pioneering firm focused on advancing gene and cell therapy technologies. The company aims to leverage these innovative approaches to regenerate the thymus gland, a critical organ for the adaptive immune system.

Project Acronym: i-THYMUS
Funding Type: Grant first
Submission Details: Genewity submitted its Step 2 proposal on March 22, 2023, subsequently succeeding in the Step 3 interview.

Project Description: i-THYMUS

The i-THYMUS project aims to harness the potential of gene therapy, cell therapy, and induced pluripotent stem cells (iPSCs) to regenerate the thymus gland and restore the function of the adaptive immune system.

Technology Background:

Significance of the Project

The i-THYMUS project addresses a critical need in immunology, particularly for individuals with compromised immune systems due to age, disease, or genetic factors. By regenerating the thymus, Genewity aims to enhance the adaptive immune response, offering potential therapies for various immunodeficiencies and related conditions. The project not only contributes to scientific knowledge in the field of immunology but also stands to impact public health significantly by improving health outcomes for vulnerable populations.

Conclusion

The EIC Accelerator program is a vital component of the European innovation ecosystem, providing substantial funding and support to high-potential startups like Genewity B.V. Through initiatives like the i-THYMUS project, the program facilitates the development of revolutionary technologies that can transform healthcare and improve lives. As the program continues to evolve, its impact on fostering innovation and collaboration within the DeepTech sector remains invaluable.

2 The Funding Rounds

# Genewity B.V.: EIC Accelerator Funding and Company Profile

Genewity B.V. is a clinical-stage biotechnology company founded in 2022 and based in Leiden Bioscience Park, Netherlands. The company specializes in developing advanced treatments using extracorporeal gene therapy with lentiviral vectors, enabling the modification of stem cell characteristics for innovative gene-modified cell therapies.

Funding History

Genewity secured funding from the European Innovation Council (EIC) Accelerator program in March 2023. This funding represents a significant milestone for the company, coming approximately one year after its founding in 2022. The EIC Accelerator program is designed to support innovative startups and SMEs with high growth potential.

The company submitted its Step 2 proposal to the EIC Accelerator on March 22, 2023, and subsequently succeeded in the Step 3 interview phase, resulting in the funding award. The specific amount of the EIC Accelerator funding is not disclosed in the available information.

Business Focus

Genewity focuses on generating thymus cells from pluripotent stem cells to develop treatments for:

• Congenital athymia (complete absence of a thymus gland)
• Autoimmune diseases

The company's lead product, i-Thymus, received significant regulatory recognition in 2024, with both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) granting it Orphan Drug Designation for the treatment of congenital athymia. This designation provides several benefits:

• Market exclusivity for up to ten years in Europe and seven years in the U.S. following approval
• Financial incentives including reduced regulatory fees in the EU and tax credits for clinical trials in the U.S.
• Personalized regulatory guidance on clinical trial design and the overall regulatory pathway

Company Structure and Development

As a relatively young biotech company, Genewity appears to be in the early clinical stage of development. Led by CEO Dr. Arno Bisschop, the company is working toward advancing i-Thymus to manufacturing under Good Manufacturing Practices (GMP) and clinical-stage investigations.

The company is registered as Genewity Holding B.V., with its headquarters in the Leiden Bioscience Park, a prominent biotech hub in the Netherlands. While detailed financial information about the company's valuation is not publicly available, it has been described as a "small, ambitious team" by its CEO.

No information regarding additional funding rounds beyond the EIC Accelerator funding in March 2023 is available in the provided data. Similarly, there is no indication of exit events such as IPOs, buyouts, or acquisitions involving Genewity B.V. As a recently founded company (2022) that received EIC funding in 2023, Genewity appears to be in its early growth and development stages, focusing on advancing its therapeutic pipeline.

Sources: - Genewity receives both EMA and FDA Orphan Drug Designation

• Genewity company information on Dealroom.co
• Genewity company information on Investny.org

3 The Press Releases

Genewity B.V.: Post-EIC Accelerator Funding Developments Genewity B.V., a Netherlands-based biotech company specializing in thymus-driven therapies for immune reconstitution, secured EIC Accelerator funding in 2023. Since then, the company has focused on advancing its core technology, i-Thymus, an autologous gene-modified cell therapy designed to treat congenital athymia and autoimmune disorders.

Key Updates

• Regulatory Milestones: Genewity obtained Orphan Drug Designation from both the EMA and FDA for i-Thymus, accelerating its clinical development pathway.
• Leadership Expansion:
• Appointed Bart Bergstein as Chief Financial Officer (CFO) in May 2024 to strengthen financial strategy.
• Named Willem-Jan Krebber Chief Operating Officer (COO) in September 2024 to oversee clinical and commercial scaling.
• Technology Development: The company is refining its platform to generate thymic cells from pluripotent stem cells using lentiviral vector technology, aiming to address unmet needs in immune system restoration.

Strategic Focus

Genewity operates at Leiden Bioscience Park with a dual focus: advancing preclinical research through academic collaborations and progressing toward clinical trials. Its licensing agreements with Dutch University Medical Centers underpin both research and clinical activities while maintaining separation to avoid conflicts.

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Sources

• News - Genewity
• About Genewity

4 The Technology Advancements

Genewity B.V.: Current Capabilities and Advancements

Genewity B.V. is a biotechnology company based in Leiden, the Netherlands, specializing in developing advanced treatments using extracorporeal gene therapy with lentiviral vectors. The company focuses on generating thymus cells from pluripotent stem cells to treat congenital athymia and autoimmune diseases.

Current Capabilities

Genewity harnesses cutting-edge biotechnology to develop autologous thymus tissue, aiming to restore the immune system with minimal rejection risk. Its product pipeline includes i-Thymus, currently in the preclinical stage, and i-TOL, in the discovery stage. The company collaborates closely with leading institutions and industry partners, contributing to rigorous preclinical and clinical research.

Advancements Since EIC Accelerator Funding

Following the EIC Accelerator funding in March 2023, Genewity has made significant advancements:

• Optimization of Gene Therapy Vectors: The company has improved its gene therapy vector to enhance cell differentiation and thymus functionality, which is crucial for consistent outcomes in future clinical applications.
• Establishment of Humanized Mouse Model: Genewity has developed a commercial athymic mouse model with human immune progenitor cells to study the efficacy of i-Thymus in developing human T-cells.
• Regulatory Milestones: Genewity received both EMA and FDA Orphan Drug Designation for i-Thymus, marking an important milestone in its development and providing regulatory support and market exclusivity.

Technology Improvements and Demonstrations

Genewity has not publicly demonstrated its technology in the market through customer trials or pilots but is actively involved in preclinical research. The development of i-Thymus involves creating patient-specific organoids using stem cell technology, differentiating induced pluripotent stem cells (iPSCs) into thymus cells.

New Patents, Scientific Studies, and Clinical Trials

While there are no recent publications of new patents or scientific studies, Genewity has filed a patent application and registered trademarks to secure its proprietary technology. The company is preparing for clinical trials by enhancing its GMP production capabilities and seeking partnerships for transitioning to the clinical stage.

Sources

• Genewity
• Genewity B.V. | The Org
• The i-Thymus: wielding the potential of gene therapy, cell ... - CORDIS

5 The Partnerships and Customers

Genewity B.V.: Strategic Partnerships and Market Positioning Post-EIC Accelerator Funding Since securing EIC Accelerator support in March 2023, Genewity B.V. has advanced its mission to develop thymus-driven therapies for immune deficiencies. While specific customer names remain undisclosed, the company’s progress highlights critical collaborations and regulatory milestones shaping its trajectory.

Key Partnerships and Collaborations

Genewity collaborates with Dutch University Medical Centers, leveraging licenses to execute research programs and clinical trials. These partnerships enable access to academic expertise and infrastructure for preclinical and clinical development. The company also participates in European research grants, as evidenced by their Horizon project (CORDIS ID: 190124491) focused on gene therapy integration for thymus cell generation.

Regulatory Milestones

In 2024, Genewity obtained Orphan Drug Designation from the EMA and FDA for i-Thymus, a therapy targeting congenital athymia. This dual designation accelerates regulatory pathways in both markets, providing market exclusivity (10 years in the EU, 7 years in the U.S.) and financial incentives such as reduced fees and tax credits.

Market Positioning Through Relationships

• Academic-Clinical Synergy: By aligning with medical centers like LUMC (Leiden University Medical Center), Genewity bridges translational research gaps, ensuring patient-centric development aligned with RegMed XB’s cross-border initiatives.
• Regulatory Leverage: Orphan status enhances credibility with investors and clinicians, positioning i-Thymus as a frontline candidate for rare disease treatment.
• Technology Scaling: Lentiviral vector-based platforms benefit from shared pilotline infrastructure within RegMed XB’s network, optimizing manufacturing processes alongside partners like NecstGen.

Technological Advancements Supported by Collaborations

Genewity’s work on pluripotent stem cell-derived thymus cells relies on academic partnerships for gene-editing validation. Participation in EU-funded projects further integrates interdisciplinary expertise in immunology and gene therapy scaling.

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Sources

• Genewity Official Website
• EIC Selects 51 European Startups
• CORDIS i-Thymus Project Details
• RegMed XB Annual Report 2023

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6 The Hiring and Company Growth

Genewity B.V.: Team Growth and Scaling Post-EIC Accelerator Funding Genewity B.V., a clinical-stage biotech company based in Leiden, Netherlands, specializes in thymus-driven therapies and gene-modified cell treatments for immune disorders. Founded in 2022, the company has positioned itself as a pioneer in immune reconstitution therapies, leveraging lentiviral vector technology to develop autologous cell therapies.

Current Hiring and Team Growth

• Hiring Status: As of the latest available data (company website accessed May 2025" class="inline-link" target="_blank" rel="noopener noreferrer">EMA/FDA Orphan Designation Announcement, Genewity’s careers page states there are no open vacancies. However, this does not preclude recent hires or non-public recruitment efforts tied to post-funding scaling.
• Headcount: Specific employee numbers are not disclosed publicly. The management team includes seven executives: CEO Arno Bisschop, CFO Bart Bergstein, CDO Willem-Jan Krebber, CBO Max Renes, CLO Rob Posthumus, Director of Operations Katja Jansen, and Directors of Preclinical Development Aline Zbinden and Ying Poi Liu. Additional roles likely include R&D scientists given their academic collaborations, but exact team size remains unspecified.
• Growth Trajectory: Since its 2022 founding, Genewity has established partnerships with Dutch medical centers and secured licenses for clinical trials, indicating steady operational growth. EIC Accelerator funding (awarded March 2023) typically supports scaling activities such as hiring or trial expansion; however direct evidence of headcount increases post-funding is not publicly detailed.

Key Positions and Strategic Scaling

While recent hires are not explicitly listed on their website or third-party sources like Dealroom.co, the existing leadership reflects expertise spanning immunology (Bisschop’s background), finance (Bergstein), legal compliance (Posthumus), and preclinical development (Zbinden/Liu). Expansion into clinical trial execution suggests potential growth in regulatory affairs or manufacturing roles to support commercialization efforts linked to their thymic cell therapies for athymia patients.

Management Stability

The founding management team remains intact based on public profiles from Genewity’s website and Dealroom.co records since its 2022 inception. No turnover or restructuring is reported as of May 2025.

Future Outlook

Genewity’s focus on bridging academic research with clinical application—coupled with EIC funding—positions it to advance trials for congenital athymia treatments while potentially diversifying into autoimmune disease applications long-term.

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Sources

• Genewity Official Website - Leadership details & therapeutic focus areas
• Dealroom.co Company Profile - Founding year & location data

7 The Media Features and Publications

Genewity B.V.: Post-EIC Accelerator Funding Trajectory and Public Engagement Since securing EIC Accelerator funding in March 2023, Genewity B.V., a Netherlands-based biotech firm specializing in thymus-regenerative therapies, has marked significant milestones through regulatory achievements, public communications, and strategic collaborations. Below is a synthesis of their media presence, publications, and event participation post-funding:

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Media Features & Regulatory Milestones

In October 2024, Genewity announced dual Orphan Drug Designations from the EMA and FDA for its lead product i-Thymus, targeting congenital athymia. This recognition underscores the therapy’s potential to address unmet needs in immune deficiencies. The company’s website highlights its focus on autologous thymus tissue engineering, emphasizing reduced rejection risks through patient-derived stem cells.

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Publications Naming Genewity

• CORDIS EU Research Projects: Genewity’s involvement in EU-funded initiatives like the i-Thymus project is documented on CORDIS portals, detailing its gene-editing approach using lentiviral vectors to generate functional thymic cells.
• RegMed XB Annual Report: The 2023 report lists Genewity as one of four spin-offs emerging from regenerative medicine projects supported by cross-border collaborations.

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Podcasts & Interviews

While no direct podcasts or interviews are publicly listed from the provided sources, CEO Dr. Arno Bisschop has been quoted discussing i-Thymus’s clinical potential following regulatory milestones. The absence of dedicated interview transcripts suggests a focus on written press releases and institutional updates.

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Conference Participation & Presentations

• Internal Team Growth: In September 2024, Willem-Jan Krebber joined as COO to streamline clinical production—a move highlighted in company announcements but not yet linked to specific conferences.
• Research Collaborations: Though direct event participation isn’t detailed in sources, Genewity emphasizes partnerships with Dutch academic institutions (e.g., Leiden Bioscience Park) involved in gene therapy trials.

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Event Involvement

The company strengthened its digital presence post-EIC funding with an updated website featuring news sections and team profiles but has not yet disclosed physical event attendance beyond implied academic partnerships.

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Sources:

Genewity Official Website Orphan Drug Announcement CORDIS Project Listing RegMed XB Annual Report Dutch Gene Therapy Overview Patent Reference