New Phase I Immunological Data Presented at SITC 2025 Support TG4050’s Potential Role in Preventing Cancer Relapse

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC [*]patientsComprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse Conference call scheduled on November 14 at 4 p.m. CET (in English). See details below. Strasbourg, France & Tokyo,...

Illkirch Graffenstaden, 04/11/2025 (informazione.news - comunicati stampa - economia)

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC patients

Comprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse

Strasbourg, France & Tokyo, Japan, November 4, 2025, 5:45 p.m. CET – a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and will jointly present profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine ( ) TG4050 The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Comprehensive immunogenicity data confirm TG4050’s ability .

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Data presented at SITC demonstrate that :

The is available on both the SITC and Transgene websites. The will take place on and will be available that day on both the SITC and Transgene’s websites.

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Transgene and NEC previously shared data (see press release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

, from 10:00 a.m. to 11:00 a.m. ET (4 p.m. to 5 p.m. CET).

https://lifescievents.com/event/fsp25g74n/

The webcast and the replay will be available here and on Transgene’s website following the live event.

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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 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 viral vector-based modalities.
With Transgene’s platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The ® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations, identified and selected through advanced Artificial Intelligence technologies.
With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.
Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene

® is a viral vector (MVA – Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. ®-derived products are designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded “Investment for the Future” funding from Bpifrance for the development of its platform ®. TG4050 is the first ®-derived product being evaluated in clinical trials. Click here to watch a short video on c®.

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s ® 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 accurately prioritize and select 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.

TG4050 is being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. In the Phase I part, thirty-two evaluable patients have been included. First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026. The first efficacy data will become available as soon as all patients display two-year follow-up from randomization unless an event (relapse, death or lost to follow-up) occurs earlier.

NEC’s neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T-cell response. With NEC OncoImmunity now on board, NEC continues to strengthen its top-class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide.
For more information, please visit NEC Bio at https://www.nec-bio.com or https://www.nec-bio.com/en_DD/research-and-innovation/our-approach/

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, and follow us on Instagram, Facebook, and LinkedIn.

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