Combining cutting-edge proprietary technologies and enhanced manufacturing, TG4070 is positioned as a novel vaccine relevant to multiple tumor types
TG4070, the second candidate from the myvac® platform:
- Full internalized AI-driven capabilities with SNIPER, a novel neoantigen prediction tool
- Scalable cell-line manufacturing designed to support faster vaccine supply and broader platform deployment
- New randomized Phase 1 trial in combination with immune checkpoint inhibitor in adjuvant NSCLC1 – Patient screening to start in coming weeks
TG4050, the first candidate from the myvac® platform, continues to progress in Phase 2, with topline data expected in Q1 2028. Plan to move to cell-line manufacturing for potential next trials in HNSCC2
Conference call scheduled on June, 29 at 3 p.m. CET / 9:00 a.m. ET (see details below).
Webcast registration: https://lifescievents.com/event/ri20slf0/
Strasbourg, France, June 22, 2026, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces the initiation of a randomized Phase 1 trial evaluating TG4070, a novel individualized immunotherapy fully designed and developed in-house by Transgene, in combination with nivolumab in the adjuvant treatment of resected non-small cell lung cancer (NSCLC).
TG4070, Transgene’s second Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, reflects the strategic expansion of the myvac® platform. Following TG4050, currently being evaluated in the Phase 2 part of a randomized Phase 1/2 trial in head and neck cancer (NTC4183166), TG4070 supports the expansion of the myvac® platform into NSCLC while integrating Transgene’s proprietary AI-driven neoantigen selection and cell line manufacturing capabilities. Like TG4050, it leverages Transgene’s clinically validated Modified Vaccinia Ankara (MVA) viral vector, ensuring technological consistency of the myvac® platform.
This integrated proprietary ecosystem strengthens Transgene’s control over critical steps of INTV development, with an optimized manufacturing process, aiming at shortening turnaround time (compared to CEF3 based production), improving scalability and reproducibility, while potentially accelerating development timelines across multiple indications.
“The initiation of this randomized Phase 1 trial of TG4070 represents an important step in Transgene’s strategy to expand the myvac® platform beyond TG4050 in head and neck cancer, into additional early-stage solid tumor indications,” said Alessandro Riva, MD, Chairman and Chief Executive Officer of Transgene.
“The program reflects the growing integration of Transgene’s proprietary capabilities across AI-driven neoantigen selection through SNIPER and scalable manufacturing infrastructure designed to support broader platform deployment.”
SNIPER: Proprietary AI Platform Enabling High-Precision Neoantigen Selection
To support the development of TG4070 and future myvac®-derived candidates, Transgene has developed its own in-house, AI-driven bioinformatics tool, SNIPER (Specific Neoantigen Identification and Prediction of Elicited Response). SNIPER is the central component underpinning the neoantigen selection and design of TG4070.
With its multiple integrated computational models, SNIPER is designed to identify and prioritize highly immunogenic neoantigens through a proprietary scoring framework, including tumor-specific expression and antigen presentation intended to optimize candidate selection and support INTV design.
SNIPER highlights Transgene’s strong capabilities in AI-driven neoantigen selection, empowering robust computational development and enabling the scalable development of myvac®-derived candidates across additional oncology indications.
In addition, VacDesignR®, fully integrated into the myvac® platform, is Transgene’s patented in-house computational design engine that optimizes genetic construct for MVA vectors. This integration streamlines design process and significantly improves production reliability and vector quality – key features to achieving reliable, timely and efficient product supply.
Cell-line optimized manufacturing to support broader development
TG4070 is manufactured using a scalable and transposable cell-line based process designed to support broader deployment of INTV candidates while ensuring reliable vaccine supply. Compared with conventional CEF-based manufacturing, the optimized process enables more efficient and automated production, improved lead times and scalability.
Preclinical data demonstrated comparable performance to CEF-based product, supporting continuity with existing clinical data while significantly enhancing scalability.
This manufacturing evolution supports broader deployment of the myvac® platform across additional indications and larger patient populations. Transgene also plans to use cell-line based manufacturing in potential future TG4050 clinical trials. TG4050 is currently being evaluated in Phase 2 in head and neck cancer.
TG4070: Expanding the myvac® Platform into resected non-small cell lung cancer
The Phase 1 trial will evaluate the safety and tolerability of TG4070 in combination with nivolumab in resected NSCLC patients after neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00).
While a perioperative approach with an immunotherapy-based regimen has reshaped the treatment landscape of early-stage NSCLC, approximately 65% of patients do not achieve a major pathological response4 and remain at high risk of relapse5.
"Patients with resected non-small cell lung cancer who do not achieve a major pathological response after neoadjuvant chemo-immunotherapy remain at significant risk of relapse. TG4070 represents a compelling approach in this setting, as individualized neoantigen therapeutic vaccines can induce highly specific and durable anti-tumor immune responses. In combination with an immune checkpoint inhibitor such as nivolumab, this strategy has the potential to further enhance T-cell activity and improve outcomes in this high-risk population," said Nicolas Girard, MD, PhD, Professor of Thoracic Oncology at Curie Institute and Principal Investigator of the TG4070 trial.
Transgene will host a webcast on June 29, 2026, at 3:00 p.m. CET / 9:00 a.m. ET (in English).
During this live event, Transgene’s team, including Alessandro Riva, Chairman and CEO, and Prof. Nicolas Girard, MD, PhD, (Institut Curie), will discuss the expansion of the myvac® platform, the medical need for early-stage NSCLC patients and the potential benefit of TG4070 in this indication.
Register here: https://lifescievents.com/event/ri20slf0/
A replay of the webcast will be available on the Transgene website following the live event.
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Contacts
| Transgene: | |
| Media: | Investors & Analysts: |
| Caroline Tosch | Lucie Larguier |
| Corporate and Scientific Communications Manager | Chief Financial Officer (CFO) |
| +33 (0)3 68 33 27 38 | Nadege Bartoli |
| communication@transgene.fr | Investor Relations Analyst and Financial Communications Officer |
| MEDiSTRAVA | +33 (0)3 88 27 91 00/03 |
| Frazer Hall/Sylvie Berrebi | investorrelations@transgene.fr |
| + 44 (0) 203 928 6900 | |
| transgene@medistrava.com |
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. TG4070, a second individualized vaccine candidate derived from the myvac® platform, is in Phase 1 clinical development in combination with nivolumab in adjuvant non-small lung cancer (NSCLC). 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 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 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: LinkedIn: @Transgene — X: @TransgeneSA — Bluesky: @Transgene
About myvac®
myvac® is a viral vector (MVA – Modified Vaccinia Ankara)-based individualized immunotherapy platform developed by Transgene to target solid tumors. myvac®-derived products are designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer specific genetic mutations. To support this approach, Transgene has established a highly integrated set of end-to-end capabilities combining artificial intelligence, bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. TG4050, its first candidate, is currently evaluated in a randomized Phase 2 in resected HNSCC. TG4070, its second candidate, is being evaluated in a randomized Phase 1 trial in NSCLC. Transgene has been awarded “Investment for the Future” funding from Bpifrance for the development of its platform myvac®. Click here to watch a short video on myvac®.
About TG4070
TG4070 is the second AI-driven individualized immunotherapy being developed for solid tumors based on Transgene’s myvac® platform. It leverages SNIPER, Specific Neoantigen Identification and Prediction of Elicited Response, Transgene’s proprietary AI-driven bioinformatics tool that enables the precise identification and prioritization of highly immunogenic neoantigens through a proprietary scoring framework, strengthening the potential efficacy of the therapy. Based on a viral vector (MVA – Modified Vaccinia Ankara), TG4070 is engineered to encode patient-specific neoantigens identified through advanced genomic analysis and artificial intelligence-driven prediction technologies. It is produced using a cell line, enabling a robust and readily scalable manufacturing process.
TG4070 is designed to stimulate the patient’s immune system to generate a targeted T-cell response against tumor-specific mutations, with the objective of recognizing and eliminating residual cancer cells and reducing the risk of disease recurrence.
The candidate is in a randomized Phase 1 development in combination with nivolumab as adjuvant treatment for patients with resected non-small cell lung cancer (NSCLC) (EUCT 2025-520946-31-00).
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
1 Non-small cell lung cancer
2 Head and neck squamous cell carcinoma
3 Chicken embryo fibroblasts
4 Disappearance of at least 90% of tumor cells
5 Source: CheckMate 77T trial (https://clinicaltrials.gov/study/NCT04025879) F. Tanaka et al. Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T
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