Personalized vaccine TG4050 induces polyepitopic immune responses against private neoantigens in resected HPV-negative head and neck cancers

TG4050 is a neoantigenic cancer vaccine derived from Transgene’s myvac platform and leverages NEC’s Artificial Intelligence (AI) technologies to identify and predict the most potent neoantigens for immunogenicity. According to the data presented at the AACR 2024 conference, at a median follow-up duration of 18.6 months, all assessable patients who received the vaccine following standard-of-care adjuvant chemoradiotherapy (n = 16; arm A) remained in remission. Among those placed in the observation group (n = 16; arm B), three individuals encountered disease recurrence at 6.2, 8.8, and 18.5 months, respectively. Additionally, immune responses were assessed in 16 vaccinated individuals in arm A and one vaccinated individual in arm B. Around 16 patients exhibited activated neoantigen-specific T cells, which were not detected prior to receiving TG4050, indicating vaccine-induced activation. Furthermore, following vaccination, the quantity of these T cells rapidly rose and remained consistent for up to 7 months post-vaccination.

CD4-positive and CD8-positive reactions were detected in 16 out of 17 evaluable patients who received the TG4050 vaccine. Additionally, the vaccine triggered a targeted immune response against 33% of the mutations, with the majority (80%) of immune reactions observed post-vaccination being absent at baseline.

Adverse effects reported with the vaccine were reportedly mild to moderate. The most common treatment-related toxicity was injection site reaction. Overall, the findings indicate that TG4050 is safe and promotes an immune response against several neoantigens in most patients.

KOL insight

“The immunological data generated by TG4050 show a strong and specific cellular immune response, despite strict measurement criteria. The diversity, quality, and persistence of these responses were, without no doubt, a key factor in preventing relapses in patients treated with TG4050.”–Expert Opinion

“TG4050 elicited unambiguous CD8-positive T-cell responses toward tumor antigens.”–Expert Opinion

Conclusion

Following surgery and adjuvant chemoradiotherapy, the personalized neoantigen vaccine TG4050 stimulated tumor-specific immune reactions, leading to minimal relapse rates among patients with resected human papillomavirus (HPV)–negative head and neck cancers. In addition to that, TG4050 is already demonstrating a beneficial effect for patients with head and neck cancers at high risk of relapse. So based on this, the company is looking forward to starting the Phase II trial in the adjuvant treatment of head and neck cancer.