Transgene and ProBioGen have broadened the scope of their existing collaboration through an additional license agreement for ProBioGen's AGE1.CR.pIX suspension cell line, aimed at enhancing Transgene's manufacturing capabilities.

Expanding an established manufacturing partnership

The additional license agreement centres on ProBioGen's AGE1.CR.pIX suspension cell line platform, which is designed to enable highly efficient manufacturing processes for vaccine production. The platform supports reliable, cost-effective production and increased productivity. The continued partnership underscores a shared commitment to advancing vaccine innovations through manufacturing scalability and optimisation support.

About the AGE1.CR.pIX platform

ProBioGen's AGE1.CR.pIX cell line is a stable proliferating avian cell line derived from primary cells of a duck embryo, developed as an alternative to the use of chicken eggs for large-scale vaccine production. Key characteristics of the platform include:

• Available as both a suspension and adherent cell line
• Optimised for viral vaccine production and stability
• Grows in a commercially available, chemically defined medium without animal components
• Qualified as a GMP master cell bank, ensuring every batch begins from the same fully characterised starting material
• Supports reproducible, scalable, and transferable manufacturing processes

Leadership perspectives on the agreement

Dr. Alessandro Riva, Chairman and Chief Executive Officer of Transgene, said the additional license reflects confidence in the technology to prepare for future clinical needs at scale. Dr. Volker Sandig, Chief Scientific Officer at ProBioGen, noted that a continuous cell line qualified as a GMP master cell bank, grown in chemically defined and animal-component-free medium, means every batch begins from the same fully characterised starting material, providing a foundation that is reproducible, scalable, and straightforward to transfer.

About the companies

Transgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Its clinical-stage portfolio includes viral vector-based immunotherapeutics, with TG4050 as its lead asset — an individualised therapeutic vaccine based on the myvac platform with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. TG4070, a second individualised vaccine candidate from the myvac platform, is in Phase 1 clinical development in combination with nivolumab in adjuvant non-small lung cancer. The company also has BT-001, an oncolytic virus based on the Invir.IO viral backbone, in clinical development.

ProBioGen is a Berlin-based contract development and manufacturing organisation specialising in biopharmaceuticals, viral vectors, and vaccines. Operating for over 30 years, ProBioGen runs three manufacturing lines in Berlin, where 300 employees contribute to advancing next-generation therapies and global biotech innovation.

Transgene and NEC Corporation reported 100% three-year disease-free survival (DFS) for patients treated with TG4050 in a Phase 1 trial for head and neck cancer.

The companies also announced the publication of comprehensive Phase 1 clinical and translational data in Nature Communications. The findings highlight durable neoantigen-specific T cell responses in patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC).

Clinical Outcomes

Three-year follow-up data from the Phase 1 part of the randomized Phase 1/2 trial demonstrate sustained clinical outcomes in the adjuvant setting. All 16 patients treated with TG4050 remained disease-free after a median follow-up of 41 months. In contrast, three of 16 patients in the control arm experienced relapse.

TG4050, which encodes up to 30 patient-specific neoantigens, maintained a favorable safety profile with no unexpected safety findings reported during the study period.

Immune Response Data

The peer-reviewed publication details robust and persistent neoantigen-specific CD8+ T-cell responses consistent with the vaccine’s mechanism of action. Key immunological findings include:

• Vaccine-induced responses were detected in 73.3% of patients treated with TG4050.
• Responders showed a median of three responding neoantigens per patient.
• These immune responses persisted for more than one year after the last vaccination.

Alessandro Riva, Chairman and CEO of Transgene, stated that the sustained neoantigen-specific immune responses provide evidence that the individualized therapeutic vaccine approach can generate durable anti-tumor immunity.

What the Numbers Show

The divergence between the treatment and control arms is stark: while 100% of TG4050-treated patients remained disease-free at the three-year mark, the control arm saw a relapse rate of approximately 18.75% (three out of 16 patients). This separation, combined with the high responder rate (73.3%) for neoantigen-specific T cells, suggests a strong correlation between the vaccine-induced immune response and sustained clinical remission in this cohort.

Next Steps

TG4050 continues to be evaluated in the ongoing randomized Phase 1/2 clinical trial (NCT04183166). Upcoming milestones include:

• First immunological data from the Phase 2 study in H2 2026.
• Two-year efficacy data (DFS) from the Phase 2 study in Q1 2028.

Masaki Kondo, Managing Director of NEC’s Life Science Division, noted that the results demonstrate the capacity of NEC’s AI-powered neoantigen prediction to identify tumor targets capable of generating clinically meaningful immune responses.