Transgene and NEC Bio Sign License Agreement to Prepare the Next Steps of the Development of TG4050 in Head and Neck Cancer

Transgene and NEC announced the signing of a license agreement to advance the clinical development of TG4050, an individualized neoantigen therapeutic vaccine 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."

Source: Transgene and NEC media announcement