On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its lead asset TG4050 developed from its myvac platform, upcoming plans, and its financial position as of September 30, 2025.
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TG4050 – INTV: New Data presented at SITC (Free SITC Whitepaper) supports TG4050’s potential role in preventing cancer relapse
Transgene and its partner NEC1 will jointly present a poster on additional immunological data profiling the neoantigen-specific T-cell response after treatment with TG4050 in head and neck cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to induce neoantigen-specific cytotoxic CD8+ T-cell responses capable of targeting and eliminating tumor cells – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.
These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.
These results follow the positive randomized Phase I data presented in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO Annual Meeting – see press release).
The SITC (Free SITC Whitepaper) abstract is available both on the SITC (Free SITC Whitepaper) and Transgene websites. The poster presentation will take place on November 8 at the Conference and will be available on Transgene’s website following the presentation.
Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.
Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.
Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of its lead asset, TG4050, with the goal of bringing it to patients with operable HNSCC as quickly as possible.
myvac platform: Potential to reduce the risk of relapse across multiple operable solid tumors
Transgene’s INTV platform, myvac, could be applied across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel, Transgene is initiating start-up activities for a potential new Phase I trial in a second indication in an early treatment setting, with the aim of initiating once all conditions are met.
BT-001 (oncolytic virus – intratumoral administration): Updated Phase I/II data presented at ESMO (Free ESMO Whitepaper) 2025 demonstrated positive antitumoral activity
Transgene and BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting – see press release.
These updated data from the Phase I trial (NCT04725331) evaluating BT-001 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab)2 showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones.
The poster is available on Transgene’s website.
Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.
Key financial elements
In millions of euros Q3
2025 2024
Research Tax Credit 5.8 4.8
Revenue from collaborative and licensing agreements 0.1 -
Other income 0.3 0.2
Operating income 6.13 5.0
During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.
As of September 30, 2025, Transgene had €12.8 million in cash, compared to €16.7 million as of December 31, 2024.
Over the first nine months of 2025, Transgene’s net cash burn4 was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.
Business funded until the end of December 2026
In March 2025, the Company signed a new amendment to the current account advance agreement with its major shareholder TSGH (Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.
With this credit facility and the support of TSGH (Institut Mérieux), Transgene is able to fund its business until the end of December 2026, enabling the Company to deliver significant news flow on its myvac platform over the next 12 months.
(Press release, Transgene, NOV 4, 2025, View Source [SID1234659389])