Strasbourg, France & Schiphol, Netherlands, Apr 3, 2026 - (JCN Newswire) - Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Bio B.V. ("NEC"), a wholly owned subsidiary of NEC Corporation (TSE: 6701), a leader in IT, network and AI technologies, announce the signing of a license agreement to advance the clinical development of TG4050, an individualized neoantigen therapeutic vaccine (INTV) in the adjuvant treatment of resected HPV-negative head and neck cancer.

TG4050 is an individualized immunotherapy based on an MVA viral vector incorporating neoantigens selected using NEC’s AI-enabled prediction platform. It is currently being evaluated in patients with head and neck cancer with the aim of preventing relapse and extend disease-free survival following surgery and adjuvant therapy. TG4050 is designed to stimulate and educate the immune system against a patient’s cancer using tumor-specific genetic mutations (neoantigens) targeting each patient’s unique tumor. These neoantigens are identified and selected using NEC’s proprietary platform, which applies advanced machine learning to select immunogenic mutations that are most likely to induce a strong immune response.

Under the terms of the license agreement, Transgene secures access to NEC’s AI-based neoantigen prediction platform for further development of TG4050 in the adjuvant treatment of resected HPV-negative head and neck cancer while conferring rights to enable Transgene’s further clinical development and to support commercialization and potential partnering of the program. NEC retains full ownership and operational control of its AI platform and will support Transgene to conduct further clinical activity.

NEC will receive a technology access fee of €2.5 million in Transgene shares following the signing (see below) and an additional €2.5 million in cash to be paid out in a series of tranches through early 2028. Additionally, a further payment will be milestone-based and a portion of such payment will be made in Transgene’ shares. NEC is also eligible to receive undisclosed additional consideration including development milestone payments, as well as a double-digit share of profits or licensing revenues.

"Building on the results of our long-standing collaboration and with the license to use NEC’s prediction platform, we are now in a strong position to pursue further development of TG4050, which will be informed by data from our ongoing Phase 2 trial. We are also pleased to welcome NEC as a shareholder of Transgene and appreciate their confidence as we work together to advance a treatment that has the potential to improve the outcomes for patients at risk of relapse in head and neck cancer," said Dr. Alessandro Riva, Chairman and CEO of Transgene.

Akira Kitamura, GM, AI Drug Development Division of NEC Corporation and CEO of NEC Bio, added, "This agreement is an important milestone in our partnership with Transgene and reflects NEC’s long-term commitment to the development of TG4050. This collaboration is a clear example of how NEC can bring differentiated AI capabilities to biopharma. The clinical data generated to date is encouraging and support the potential of TG4050 as a promising approach to reducing relapse risk in patients with head and neck cancer. We look forward to deepening our collaboration with Transgene and to realizing the full clinical and strategic potential of this partnership."

Capital increase

As indicated above, a €2.5 million portion of the access fee to be paid to NEC will be paid in Transgene shares. Transgene will thus issue 3,345,824 new shares to NEC Bio B.V. at a price of €0.7472 per share. This price corresponds to the volume-weighted average (VWAP) of the last five (5) closing prices of the Transgene shares on the regulated market of Euronext in Paris prior to signing. The new shares will represent 1.22% of the share capital of Transgene post issuance (and 0.98% of its voting rights)1.

The capital increase is carried out on the basis of the 22nd resolution of the Combined General Meeting of May 15, 2025. The new shares will be admitted to trading on the regulated market of Euronext in Paris as soon as they are issued and will be immediately assimilated to the existing Transgene shares (ISIN code FR0005175080).

The capital increase is expected to be completed by the end of April 2026.

(1) Based on today’s share capital and voting rights.Share

About TG4050

TG4050 is an individualized immunotherapy being developed in the treatment of resected HPV-negative head and neck cancer that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based individualized neoantigen therapeutic vaccine (INTV) encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to prioritize and select the sequences that are predicted to be the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.

About Transgene

Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company’s clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the myvac® platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The Company has other viral vector-based assets, including BT-001, an oncolytic virus based on the Invir.IO® viral backbone, which is in clinical development. The Company also conducts innovative discovery and preclinical work, aimed at developing novel immunotherapies.With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X: @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene

About NEC Corporation

The NEC Group leverages technology to create social value and promote a more sustainable world where everyone has the chance to reach their full potential. NEC Corporation was established in 1899. Today, the NEC Group’s approximately 110,000 employees utilize world-leading AI, security, and communications technologies to solve the most pressing needs of customers and society. For more information, please visit https://www.nec.com, follow us on Instagram, Facebook, and LinkedIn.

About NEC Bio

NEC Bio is the biotechnology arm of NEC Corporation, headquartered in the Netherlands, and focused on leveraging state of the art AI technologies to address world's most pressing healthcare challenges. Leveraging cutting-edge science, data, and innovation, NEC Bio is dedicated to developing personalized therapies designed to transform patient outcomes and improve quality of life globally. With a growing international footprint, NEC Bio includes subsidiaries such as NEC OncoImmunity in Oslo, Norway, and NEC Bio Therapeutics in Mannheim, Germany—each contributing specialized expertise across immunotherapy, precision medicine, and translational research. Together, these entities form a collaborative ecosystem committed to accelerating innovation from discovery to patient impact.To learn more, visit www.nec-bio.com and follow us on LinkedIn for the latest updates.

Disclaimer
This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.com). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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