On November 9, 2026 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, reported a business update on its myvac-based individualized assets TG4050 and TG4070, its upcoming plans, and its financial position as of September 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 neoantigenspecific 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 linebased 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 TG4070to prevent relapsein combination with an immune checkpoint inhibitorin 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 (Free ESMO Whitepaper) 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 investigatorsponsored 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.

(Press release, Transgene, NOV 9, 2026, View Source [SID1234674487])