Transgene Reports Continued Clinical Progress and Q3 2026 Financial Update
Publication in Nature Communications confirmed TG4050’s robust clinical proof of principle, with 100% DFS sustained after more than 3 years of follow-up in head and neck cancer (HNSCC)
Expansion of the myvac® platform with the initiation of the Phase 1 clinical trial of TG4070 in lung cancer (NSCLC)
Clear strategic and clinical development plan in early-stage solid tumors with financial visibility confirmed through early 2028
Strasbourg, France, November 9, 2026, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company developing myvac®, an individualized neoantigen therapeutic vaccines (INTV) platform designed to prevent cancer recurrence, alongside a portfolio of viral vector-based candidates, today provides a business update on its myvac®-based individualized assets TG4050 and TG4070, its upcoming plans, and its financial position as of September 30, 2026.
TG4050: 100% DFS sustained after more than 3 years of follow-up
Strong Phase 1 data from the randomized Phase 1/2 trial (NCT04183166), demonstrating the potential of TG4050 to prevent recurrence in patients early-stage HNSCC at high risk of relapse following surgery and (chemo)-radiotherapy, have been published in Nature Communications (see press release). TG4050 showed a favorable safety profile and induced persistent neoantigen-specific T cell responses, with a 100% disease-free survival (DFS) rate sustained after more than three years of follow-up.
The Phase 2 part of the study is ongoing. First immunological data are expected by year end, with the aim of presenting them at a scientific conference in 2027. Transgene expects to communicate topline results from TG4050’s Phase 2 trial by the end of Q1 2028.
In parallel, Transgene continues to strengthen its manufacturing capabilities in preparation for a potential Phase 3 trial in HNSCC. This includes transitioning TG4050 into a scalable cell line-based manufacturing process.
The Company remains on track to have Phase 3-ready manufacturing capacity by
the end of 2027.
TG4070: all French clinical sites open, enabling patient recruitment to begin
TG4070, Transgene’s second Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, represents an important strategic expansion of the myvac® platform.
Combining Transgene’s own cutting-edge proprietary AI-driven technologies for neoantigen selection with scalable manufacturing capabilities, TG4070 is designed to broaden the application of individualized cancer vaccines across multiple solid tumor indications, at an early stage of the disease.
Transgene has initiated a randomized Phase 1 trial evaluating TG4070 in combination with nivolumab in patients with resected non-small cell lung cancer (NSCLC) following neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00). Five clinical sites across France are now open and recruiting, marking an important operational milestone for the study.
The aim of the trial is to evaluate the potential of TG4070 to prevent relapse in combination with an immune checkpoint inhibitor in patients who remain at risk of recurrence despite current treatment approaches.
Advancing programs and strategic activities
Interest in individualized neoantigen therapies for cancer has recently increased, following the ESMO meeting where industry reported late-stage clinical data which could confirm the viability of this approach.
Building on the clinical proof-of-principle results to date from TG4050, Transgene is actively preparing for the efficient initiation of a potential Phase 3 trial following the 2-year DFS results of the ongoing Phase 2 clinical trial, expected in Q1 2028.
With TG4070 now entering clinical development, Transgene is also investigating the broader application of its myvac® platform which has the potential to generate INTVs against a wide range of tumor types.
Alongside this growing momentum, Transgene continues to engage with potential partners and stakeholders.
Beyond myvac®, which remains the focus of the Company, Transgene continues to evaluate the development opportunities for its broader portfolio of viral vector-based immunotherapies, including TG-MVATM and oncolytic viruses. The first patient was enrolled in the investigator-sponsored OV-PRIME-R trial, conducted in collaboration with the University of Copenhagen, evaluating BT-001 in combination with an anti-PD-1 therapy in patients with pMMR (proficient mismatch repair) localized rectal cancer (see press release).
Key financial elements
Operating income amounted to €4.3 million for the first nine months of 2026 compared to €6.1 million for the same period in 2025. It mainly consisted of the Research Tax Credit, amounting to €3.9 million, compared with €5.8 million for the same period in 2025.
As of September 30, 2026, Transgene had €84.3 million in cash, cash equivalents and other current financial assets, compared to €111.9 million as of December 31, 2025.
Transgene’s cash burn1 amounted to €29.5 million in the first nine months of 2026 compared with €28.8 million for the same period in 2025.
Under current plans, the company has sufficient cash to ensure financial visibility until early 2028.
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Contacts
| Transgene: | |
| Media: | Investors & Analysts: |
| Caroline Tosch-Pourchot | Lucie Larguier |
| Corporate and Scientific Communications Manager | Chief Financial Officer (CFO) |
| +33 (0)3 68 33 27 38 | +33 (0)3 88 27 91 00/21 |
| communication@transgene.fr | investorrelations@transgene.fr |
| MEDiSTRAVA | |
| Frazer Hall/Sylvie Berrebi | |
| + 44 (0)203 928 6900 | |
| transgene@medistrava.com |
About Transgene
Transgene (Euronext: TNG) is a biotech company designing and developing individualized neoantigen therapeutic vaccines (INTV) to prevent cancer recurrence alongside a portfolio of viral vector-based candidates. With Transgene’s myvac® platform, individualized therapy enters the field of precision medicine with an immunotherapy tailored to each individual patient. The myvac® approach enables the generation of virus-based immunotherapies encoding patient-specific neoantigens. Transgene has further expanded the platform’s capabilities with its own proprietary AI-driven neoantigen selection and scalable cell-line manufacturing.
TG4050, the most advanced INTV, demonstrated clinical proof of principle in the adjuvant treatment of head and neck cancer. TG4070, the second myvac®-based INTV introduces Transgene’s proprietary AI-driven neoantigen selection and scalable cell-line manufacturing capabilities and is evaluated in combination with nivolumab in the adjuvant treatment of non-small cell lung cancer (NSCLC).
The Company is developing other viral vector-based assets including TG-MVA™, a next-generation prophylactic vaccine candidate against mpox and smallpox and a new generation of multifunctional oncolytic viruses.
Additional information about Transgene is available at: www.transgene.com
Follow us on social media: LinkedIn: @Transgene — X: @TransgeneSA — Bluesky: @Transgene
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.
1 Cash burn corresponds to the sum of net cash flows from operating, investing and financing activities, excluding proceeds from share issuances and excluding current account advance/other financial asset disposals related to the parent company. It does not include the effects of exchange rate fluctuations.
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