TG4050: Updated randomized Phase I data to be presented in Rapid Oral Presentation at ASCO 2025
Dr. Simone Steiner appointed Chief Technical Officer (CTO)
Business funded until the end of April 2026
Strasbourg, France, April 24, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today provides a business update, including itsfinancial position as of March 31, 2025.
Key events and upcoming milestones
Over the first quarter of 2025, all of Transgene’s preclinical and clinical assets progressed in line with expectations.
Individualized neoantigen therapeutic cancer vaccine (TG4050)
Transgene will deliver a rapidoral presentation on TG4050, its lead individualized neoantigen therapeutic cancer vaccine based on its myvac® platform and powered by NEC’s AI technologies, at the American Society of Clinical Oncology (ASCO) 2025 annual meeting in Chicago (USA). This oral presentation, which will take place on June 1, 2025, is part of a session that highlights clinical data that stood out among many submissions. The updated data will include disease-free survival (DFS) data at 24-month follow-up for all patients in the Phase I part of the trial evaluating TG4050 as adjuvant treatment for head and neck cancer.
As the treatment landscape evolves, these updated clinical data in the adjuvant treatment of operable head and neck cancer will be instrumental in determining TG4050’s optimal development path towards registration in this indication.
In the Phase II part of the trial, patient enrollment continues to progress at a good pace and randomization is expected to be completed on schedule in Q4 2025.
The myvac® individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025.
TG4001
The Company will present a poster on clinical data from the randomized Phase II trial of TG4001 in combination with avelumab in HPV16-positive recurrent/metastatic anogenital and cervical cancer at ASCO. While the primary endpoint of the Phase II study was not met, positive signals in the cervical cancer subgroup have been observed and further details will be included in the poster presentation.
The abstracts will be available on the ASCO website on May 22, 2025, at 5 p.m. ET.
Governance
Dr. Simone Steiner joined Transgene as Chief Technical Officer (CTO) on April 1, 2025. She is responsible for manufacturing and process development for Transgene’s innovative immunotherapy product pipeline and leads the optimization of the manufacturing process for individualized neoantigen therapeutic vaccines. She is also involved in the development of potential new candidates based on the myvac® platform, as well as in planning potential future clinical studies.
Dr. Steiner reports to Chairman and CEO, Alessandro Riva, and is a member of the Executive Committee.
Upcoming milestones
TG4050
24-month follow-up data of all patients recruited in the Ph. I part - Rapid Oral Presentation
ASCO annual conference (June 1, 2025)
Ph. II part - Randomization complete
Q4 2025
Other indication - Additional Ph. I trial to start
Q4 2025
TG4001
Clinical data to be presented – cervical cancer Poster
ASCO annual conference (June 2, 2025)
TG6050
Initial data expected (Phase I)
Q2 2025
BT-001
Updated data expected (Phase I/IIa)
H2 2025
Operating revenue
Q1
In millions of euros
2025
2024
Research Tax Credit
2.3
1.6
Revenue from collaborative and licensing agreements
0.1
-
Other income
0.1
0.1
Operating revenue
2.5
1.7
During the first quarter of 2025, operating revenue mostly comprised Research Tax Credit of 2.3 million compared to €1.6 million for the same period in 2024. This increase reflects the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer.
Cash, cash equivalents and other financial assets
Cash, cash equivalents and other financial assets stood at €15.6 million as of March 31, 2025, compared to €16.7 million as of December 31, 2024. In the first quarter of 2025, Transgene’s net cash burn was €14.8 million compared to €11.2 million for the same period in 2024. This results from progress in the Phase II part of the trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.
In March 2025, the Company signed a new amendment to the current account advance agreement with TSGH (Institut Mérieux), which increases the total amount of the facility by €15 million to €48 million. The Company has drawn down €22.5 million from this facility as of March 31, 2025.
With this credit facility and the support of TSGH (Institut Mérieux), Transgene is now able to fund its business until the end of April 2026, enabling the Company to reach important development milestones and deliver significant news flow on its portfolio.
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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. The portfolio also includes other viral-vector-based immunotherapies: TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO® viral backbone. 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 by Artificial Intelligence capabilities provided by its partner NEC. 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.fr Follow us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene— 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.fr). 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.
