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.