On September 16, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for the six-month period ended June 30, 2025, and provides an update on the myvac platform, its lead asset TG4050, and upcoming plans (Press release, Transgene, SEP 16, 2025, View Source [SID1234656003]).

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Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented: "We are extremely proud that all patients treated with TG4050 in our Phase I trial remained disease-free after a median follow-up of 30 months. These results, selected for oral presentation at ASCO (Free ASCO Whitepaper) 2025, represent a pivotal milestone for Transgene and underscore the potential of our viral vector-based individualized therapeutic cancer vaccine platform. The durable clinical benefit and robust immune responses we have observed, together with the strong enthusiasm from clinicians, reinforce our vision to deliver transformative therapies to people living with operable head and neck cancer. TG4050 continues to progress through Phase II and we look forward to sharing first data from his trial in 2026. We will also present further immunological data from our Phase I study later this year."

TG4050: Individualized Neoantigen Therapeutic Cancer Vaccine (INTV)

ASCO 2025: TG4050, the first candidate from Transgene’s myvac platform, achieves all Phase I endpoints, with 100% disease-free survival (DFS) after more than 2-years

Transgene presented positive data from the randomized Phase I part of the ongoing multicenter Phase I/II trial (NCT04183166) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2025) Annual Meeting (see press release). TG4050 was administered as a single agent in the adjuvant treatment of HPV-negative operable head and neck squamous cell carcinoma (HNSCC).

– All patients who received TG4050 remained disease-free for at least two years (median follow-up: 30 months), providing strong clinical proof of principle. TG4050 also induced durable and specific T cell responses persisting 24 months after the start of treatment.

-> In addition, the results successfully met all trial endpoints (including safety and feasibility). Additional immunological data from Phase I patients will be presented at an upcoming congress in Q4 2025. These data will provide further insight into the phenotyping of patients’ immune responses against selected epitopes. In addition, Transgene expects to communicate on the 3-year follow-up of Phase I patients in H1 2026.

Based on the positive Phase I data presented at ASCO (Free ASCO Whitepaper) and further immunological data (that will be communicated in Q4 2025), Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of TG4050 and bring it to patients with operable HNSCC as quickly as possible.

Ongoing Phase II part: critical milestones in 2026 and 2027

Initial patient screening has been completed in the randomized Phase II part of the Phase I/II clinical trial with TG4050 (see press release).

Randomization of all patients in the Phase II part is expected to be completed by the end of 2025.

First immunogenicity data and preliminary efficacy data from the Phase II part of the trial are expected in H2 2026 and Q4 2027, respectively.

Expanding the myvac potential in 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 with the development plan in HNSCC, Transgene is setting up a new Phase I trial in a second indication in an early treatment setting, with the aim to initiate it as soon as all conditions are met.

Other viral vector-based assets

BT-001 (oncolytic virus – intratumoral administration): Updated data on Phase I/II trial to be presented at ESMO (Free ESMO Whitepaper) 2025

Transgene and BioInvent will present a poster on updated data from the ongoing Phase I trial (NCT04725331) evaluating BT-001, an armed oncolytic virus expressing an anti-CTLA4 monoclonal antibody, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab)[1], at the European Society for Medical Oncology Annual Meeting (ESMO 2025 — see press release). The abstract will be available on the ESMO (Free ESMO Whitepaper) website on October 13, 2025, at 0:05 am CEST.

In previously reported data (ESMO 2024), BT-001 was well tolerated with limited adverse events and no dose-limiting toxicities. BT-001 in monotherapy was shown to shrink injected lesions in patients with advanced solid tumors.

In combination with pembrolizumab, BT-001 showed promising efficacy data with partial responses in patients with relapsed and refractory advanced melanoma and leiomyosarcoma.

Transgene and BioInvent are pursuing clinical development opportunities with clinicians for BT-001 administered intratumorally.

TG4001 (HPV16 therapeutic vaccine)

Transgene presented a poster (available here) on randomized Phase II data of TG4001 in combination with avelumab in a cervical cancer subgroup at the 2025 ASCO (Free ASCO Whitepaper) conference.

Transgene is currently evaluating potential partnership opportunities to determine the best path forward for the program.

TG6050 (oncolytic virus — intravenous administration)

The Phase I dose-escalation Delivir trial (NCT05788926), evaluating TG6050 administered by intravenous infusion, has enrolled 22 patients with advanced non-small cell lung cancer who have failed standard therapeutic options.

TG6050 has demonstrated good tolerability as monotherapy, with no new safety signals identified. However, the analysis of preliminary efficacy and translational data did not demonstrate a clear efficacy signal in the context of intravenous administration in this indication. Patient recruitment of the Phase I trial is completed, and the Company is evaluating the best way forward for this candidate.